Abstract: Provided are hybrid soft tissue constructs comprising a core material, a biomaterial matrix and mammalian cells. Also provided are methods of augmenting or reconstructing a soft tissue of a mammal. Additionally, methods of forming a hybrid soft tissue construct are provided. The use of the above constructs for augmenting or reconstructing a soft tissue of a mammal are further provided. Additionally provided is the use of the above constructs for the manufacture of a medicament for augmenting or reconstructing a soft tissue of a mammal.

Abstract: In one aspect, the present invention relates to a medical device for positioning a surgical prosthesis on a fascial defect of a tissue wall. In one embodiment, the medical device has a removable flexible member having a body portion having at least one magnetic section, and a magnet member positioned in relation to the at least one magnetic section such that a movement of the magnet member causes the flexible member to move accordingly. The surgical prosthesis is detachably attachable to the flexible member, and the flexible member is introducible into and removable from a body cavity.

Abstract: A composition for promoting tissue growth which includes a material for placing in contact with animal tissue.

Abstract: A system and method for delivering one or more implantable members, such as metal coils, via an introducer member, such as an endoscopic needle, into a space created within the submucosal layers of the LES to augment and bulk the sphincter to improve compliance in patients with gastroesophageal reflux disease. The implantable member comprises a first substantially straightened configuration when carried by the introducer member, whereby it assumes a more curvilinear or coiled configuration following deployment such that it expands against adjacent submucosal tissue, creating a bulge at the implantation site. In another embodiment, the implantable member can serve as an anchoring port for sutures or other elements introduced for gastroplication of the LES to create tissue folds that increase sphincter compliance. The implantable members may be configured to include an external portion that interconnects with an adjacent implantable member, thereby creating tension that also increases compliance of the LES.

Abstract: Described are medical devices configured for use in cosmetic surgery. The medical devices include an elongate body member having a proximal end, a distal end, and a plurality of gaps defined therebetween. At least a portion of the body member is associated with one or more layers of a collagenous extracellular matrix (ECM) material. The elongate member can include one or more tissue engaging members. In preferred embodiments, the collagenous extracellular matrix material includes one or more native or non-native bioactive components.

Abstract: An apparatus and method of distributing a load to a cartilage defect repair plug is provided. A load is applied to a first articulation layer. The load is distributed to a second layer and the load is transferred in the normal direction to the first density of subchondral bone. The load is distributed to a third layer and the load is transferred in the normal direction to a second density of subchondral bone. The load is then distributed to a fourth layer and the load is transferred in the normal direction to a third density of subchondral bone.

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 is disclosed. 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: In one embodiment the apparatus includes a first retractor, a second retractor, and a shaft. The shaft defines a central channel extending from a first end portion of the shaft to a second end portion of the shaft. The first retractor and the second retractor are configured to collectively form a lumen. The shaft is configured to be disposed within the lumen. In one embodiment method of disposing a graft within a body of a patient, includes making an incision in the body of the patient, inserting a medical device into the body of the patient through the incision, removing the shaft of the medical device from the body of the patient, and moving the first refractor within the body of the patient away from the second retractor.

Abstract: An implantable prosthesis for an anatomical defect, such as a tissue or muscle defect, that promotes tissue or muscle growth into the prosthesis and subsequently strengthens the area of the defect. At least one pocket and preferably two concentric pockets may be provided to aid with manipulating the prosthesis. Where two pockets are used, a barrier or partition exists between the pockets and the outer pocket allows manipulation of the outer periphery. The incidence of postoperative adhesions between a portion of the prosthesis and tissue, muscle or organs may be minimized with the use of a barrier layer. Reinforcing members may be attached to portions of the prosthesis to aid in positioning and deployment in the area of desired coverage without rendering the prosthesis unduly difficult to implant or uncomfortable for the patient. Typically, two concentric members are employed.

Abstract: A prosthesis for implantation into a human body is made by a method that includes the steps of providing a natural animal ligament or tendon that has a substrate, crosslinking and fixing the substrate, minimizing the antigens from the substrate, tanning the substrate to improve its mechanical properties, and coupling an active layer to the substrate.

Abstract: Mixtures, such as gels or pastes, comprising freeze-milled cartilage particles and exogenous growth factors are used for repairing chondral defects. Such mixtures may be applied to constructs comprising cancellous bone for implantation at the defect site. Suitable growth factors include variants of FGF-2, particularly variants that include a sole amino acid substitution for asparagine at amino acid 111 of the ?8-?9 loop of the FGF-2 peptide. Such FGF-2 variants are released slowly and continuously at a constant rate from cartilage pastes. In other embodiments, the amino acid substituted for asparigine is glycine. Other variants that may be used include FGF-9 variants having truncated chains and a sole amino acid substitution in the ?8-?9 loop of the FGF-9 peptide either for tryptophan at amino acid 144 or for asparagine at amino acid 143.

Abstract: An implantable tissue repair device has a cover and tissue regeneration material. The cover includes a top panel and a bottom panel joined together along a leading edge. The tissue regeneration material is positioned between the top and bottom panels. The cover includes a continuous sheet of biocompatible material extending across the edge and into the top panel and bottom panel. The cover is thicker along the leading edge than at least a portion of the top panel and thicker than at least a portion of the bottom panel. At least a portion of one of the panels covering the tissue regeneration material is thicker than a portion of the other panel covering the tissue regeneration material. A method of making the device is also disclosed.

Abstract: A method of treating a vein comprises accessing a vein at an access point spaced from a sapheno-femoral junction. A bioabsorbable fibrous body is implanted into the vein through the access point. The body is moved in the vein toward the sapheno-femoral junction.

Abstract: An intestinal submucosa tissue graft construct for use in repairing diseased or damaged tissues is provided. The graft construct comprises vertebrate intestinal submucosa tissue, added endothelial cells, and at least one additional preselected, exogenous population of cells which enhances initiation of the formation of vessel-like structures in the graft. The preselected population of cells can be a population of non-keratinized or keratinized epithelial cells or a population of mesodermally derived cells selected from the group consisting of fibroblasts, smooth muscle cells, skeletal muscle cells, cardiac muscle cells, multi-potential progenitor cells, pericytes, osteogenic cells, and any other suitable cell type, preferably selected based on the tissue to be repaired. Methods for enhancing the vascularization in vivo of these intestinal submucosa tissue graft constructs and for preparing these graft constructs are also provided.

Abstract: Methods for soft tissue repair and/or augmentation using injectable, biodegradable polymers are described herein. In one embodiment, the polymer compositions are liquid or pastes at room temperature. In a preferred embodiment, the polymer composition contains liquid or pasty hydroxy fatty acid-based copolyesters, polyester-anhydrides, or combinations thereof. The viscosity of the polymers increases upon contact with bodily fluid to form a solid or semisolid implant suitable for soft tissue repair and/or augmentation. In another embodiment, the polymer composition contains particles of a polymer stereocomplex. One or more active agents may be incorporated into the polymer compositions. Suitable classes of active agents include local anesthetics, anti-inflammatory agents, antibiotics, analgesics, growth factors and agents that induce and/or enhance growth of tissue within the filled cavity or control the growth of a certain type of tissue, and combinations thereof.

Abstract: The present disclosure relates to reticulated elastomeric matrices, and more particularly to at least partially degradable elastomeric elements that are compressible and exhibit resilience in their recovery and that can be employed in diverse applications including, without limitation, biological implantation, especially in humans.

Abstract: A dermatological skin treatment device is provided. The device comprises implant injection device, comprising, a control, an implant loader, an implant ejection port, and inserts at least one implant into a treatment area, the implant comprising a biocompatible material having a nominal length from perpendicular about 5 mm to 20 mm, the length being substantially longer than a nominal outer diameter of the implant, wherein the implant has at least two barbs preferably configured in an opposing pattern and mirrored along each respective half of the implant. The device and method inserts the implants under the skin to form new fibrous structures in a subdermal treatment area to counteract cellulite by creating a highly fibrous layer directly or through wound healing processes.

Abstract: An implant is disclosed including a bio-compatible implant body that can be provided with a tip, or interconnected by one or more filaments. The implant body can be formed of a variety of biocompatible materials, including bio-remodelable materials such as small intestine submucosa. Methods are disclosed for assembly of the implant. Additionally, a method is disclosed for delivering the implant to a desired location in a patient.

Abstract: Silk is purified to eliminate immunogenic components (particularly sericin) and is used to form fabric that is used to form tissue-supporting prosthetic devices for implantation. The fabrics can carry functional groups, drugs, and other biological reagents. Applications include hernia repair, tissue wall reconstruction, and organ support, such as bladder slings. The silk fibers are arranged in parallel and, optionally, intertwined (e.g., twisted) to form a construct; sericin may be extracted at any point during the formation of the fabric, leaving a construct of silk fibroin fibers having excellent tensile strength and other mechanical properties.

Abstract: The tether may be configured to extend through the defect and outside a patient's body to allow a surgeon to position and/or manipulate the patch from a location outside of the body. An indicator may be provided on the tether as an aid for a surgeon in determining when the patch or plug has been inserted a sufficient distance within the patient. A support member may be arranged in or on the patch or plug to help deploy the patch or plug at the surgical site and/or help inhibit collapse or buckling of the patch or plug. The patch or plug may be configured with a pocket or cavity to facilitate the deployment and/or positioning of the patch or plug over the opening or weakness.

Abstract: The invention is directed to compositions and methods for reconstructing artificial female reproductive organs. The constructs and methods of the invention can be used for ameliorating congenital malformations and disorders of female reproductive tract using tissue engineered female reproductive organs, such as the uterus, vagina, cervix, and fallopian tubes. These tissue engineered female reproductive organs can be generated by perfusing cultured cell populations derived from cells of the female reproductive tissues, such as uterine, vaginal, cervical, fallopian tube epithelial cells as well as smooth muscle cells.

Abstract: A novel method of manufacturing thick foams, especially molded thick foams useful as tissue scaffolds and other medical devices. Also disclosed are novel thick foams made using the process of the present invention, wherein such thick foams may be used as medical devices or components of medical devices.

Abstract: Disclosed are implantable tissue augmentation devices, methods, and associated tools. The devices include an inflatable body, having a self-sealing membrane operably attached to a wall of the implant. The self-sealing membrane provides access for filling the device, and includes a first layer comprising a fabric. The fabric has a first plurality of yarn strands positioned in a first direction, and a second plurality of yarn strands positioned in a second direction. The first and second plurality of yarn strands intersect to form a matrix pattern with cells defined by free spaces between yarn strands. The membrane also includes a first elastomeric material configured to fill the cells as well as form a coating over the first and second plurality of yarn strand, and a second layer comprising a second elastomeric material. The second elastomeric material has a lower durometer than the first elastomeric material. Kits and systems are also disclosed.

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: The present invention provides the use of spider silk threads for the production of tissue implants for medical use. A scaffolding matrix is provided for implantation, which matrix is comprised of spider silk thread and/or segments of spider silk threads which are cross-linked. The cross-linked spider silk thread segments essentially maintain a three-dimensional shape into which it is formed by pressing between moulds. The three-dimensional shape obtainable by moulding is sufficiently stable to be used as an implant or for colonizing by mammalian cells while essentially maintaining the three-dimensional shape. In a further embodiment, the scaffolding matrix of cross-linked spider silk segments is at least partially covered by cells autologous or heterologous to the implant recipient. The matrix colonized with cells is obtainable by in vitro cultivation of isolated cells in suspension with the scaffolding matrix.

Abstract: An implantable prosthesis for repairing an anatomical defect, such as a tissue or muscle wall hernia, including an umbilical hernia, and for preventing the occurrence of a hernia at a small opening or weakness in a tissue or muscle wall, such as at a puncture tract opening remaining after completion of a laparoscopic procedure. The prosthesis includes a patch and/or plug having a body portion that is larger than a portion of the opening or weakness so that placement of the body portion against the defect will cover or extend across that portion of the opening or weakness. At least one tether, such as a strap, extends from the patch or plug and may be manipulated by a surgeon to position the patch or plug relative to the repair site and/or to secure the patch or plug relative to the opening or weakness in the tissue or muscle wall. The tether may be configured to extend through the defect and outside a patient's body to allow a surgeon to position and/or manipulate the patch from a location outside the body.

Abstract: The present invention generally relates to particles comprising hyaluronic acid, wherein the particles are coated or encapsulated with a coating. The coating preferably comprises a polymer, protein, polysaccharide, or combination thereof that decreases the rate of degradation of the hyaluronic acid once the particles are placed in an aqueous environment, such as inside mammalian skin. The compositions of the present invention comprising such coated hyaluronic acid are useful for soft tissue augmentation, and are particularly useful as dermal fillers.

Abstract: A tissue graft is disclosed that includes a decellularized umbilical vessel having a luminal surface and an ablumenal surface, wherein the decellularized umbilical vessel is prepared by an automated dissection process. The decellularized umbilical vessel has not been substantially cross-linked. In one method of use, the decellularized umbilical vessel is capable of having at least one cell type seeded at least a portion of at least one of the luminal and ablumenal surfaces thereof. A process of preparing the tissue graft, methods of using the tissue graft, and kits which contain the tissue graft are also disclosed.

Abstract: An inguinal hernia repair device in the form of an implantable plug that is affixed at one end to the center region of a sheet of implantable material. The plug takes the form of a plurality of hollow members, arranged so as to be in substantially parallel relationship when implanted into a defect. The hollow members are preferably tubular members and are preferably bundled together by various means, such as bonding or wrapping a band or strand about the plurality of hollow members to maintain them in adjacent and contacting relationship during insertion into a defect. The device is provided with a base member for anchorage made of a composite material having a non-bioabsorable component and a bioabsorbable component.

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 artificial contractile structure generally devised to be used in the medical field to assist the functioning of an organ, includes a support (2) and one or more fibers (5) fixed thereto. The fibers are made of a contractile material which can be activated by an activator so as to provide the structure in a rest or activated position, the activated position being defined with fibers of reduced length compared to their length in the rest position. The structure is adapted to be placed around a hollow part of an organ to be contracted. The fibers are distributed along the support in order to be able to reduce the volume of the hollow part, when the fibers are contracted. The fibers and the activator are designed so that the temperature of fluids or tissues surrounding the organ does not increase above 40° C., preferably 39° C., and more preferably 38° C.

Abstract: This invention relates to a lamellae tissue layer, comprising a grooved silk fibroin substrate comprising tissue-specific cells. The silk fibroin substrates provides an excellent means of controlling and culturing cell and extracellular matrix development. A multitude of lamellae tissue layers can be used to create a tissue-engineered organ, such as a tissue-engineered cornea. The tissue-engineered organ is non-immunogenic and biocompatible.

Abstract: The present invention relates to a method of preparing a tissue graft material. The invention also relates to a multipurpose tissue graft material and to methods of using same as a replacement for vascular and non-vascular tissue.

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: Biocompatible materials for use in vascular applications or for implantation have been engineered, combining human recombinant tropoelastin with other synthetic or natural biomaterials to form protoelastin. The materials can be in the form of elastin films on metal or polymer substrates, laminates of alternating polymer and elastin, blends of polymer and elastin, or elastin crosslinked with or tethered to polymer or metal. These are mechanically stable, elastic, strong and biocompatible (i.e., not thrombogenic and promoting adhesion of cells, especially human endothelial cells), not eliciting a foreign body response. Plasma polymerization of substrate is shown to enhance biocompatibility, especially when used to bind elastin or other protein to the substrate.

Abstract: A spinal motion device for implanting in the spine as a replacement for the natural disc, to permit motion between adjacent vertebral bodies or as a vertebral body replacement that permits motion at its ends. The spinal motion device comprises a composite structure formed by a body having at least one bearing member, made from a biocompatible material such as pyrolytic carbon, attached to a support surface thereof.

Abstract: Expandable devices and methods for treating and enlarging a tissue, an organ or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material or a perforated material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The devices allow immediate direct contact between the filling material and the tissue. These devices and methods can be used for example for: horizontal and vertical bone augmentation in the jaws, soft tissue augmentation, fixating bone fractures etc.

Abstract: The present invention relates to a tissue defect repair implant including a porous material, wherein the material is expandable or compressible. The implant may be a scaffold, and may also be formed of a material such as, for example, collagen or demineralized bone matrix. Another aspect of the invention may be a method for the repair of a tissue defect in a patient in need thereof, including implanting an implant between two adjacent tissues, wherein the implant may include a porous material which is expandable or compressible. The two tissues may be soft tissue and hard tissue, and alternatively, the two tissues may be soft tissue, and may further be the same or different soft tissues.

Abstract: An artificial dura biomedical device and a brain surgery method utilizing the same are disclosed. The steps includes: fixing an artificial dura to a partial skull; and fixing the partial skull with the artificial dura to a cut hole of a whole skull. The artificial dura biomedical device includes an artificial dura and a connecting element. The connecting element fixes the partial skull with the artificial dura.

Abstract: An apparatus and system for providing reduced pressure to a defect in a nerve is disclosed. The apparatus comprises a nerve conduit having a generally tubular shape that has walls including a luminal wall surrounding the tissue site to contain fluids within a luminal space between the tissue site to contain fluids within a luminal space between the tissue site and the luminal wall. The apparatus further comprises a manifold having a porous body and a connector for receiving reduced pressure, wherein the manifold is positioned within the luminal space adjacent the tissue site to distribute the reduced pressure to the defect. Additionally, a method for providing reduced pressure to a defect in a nerve is disclosed that includes implanting the nerve conduit and manifold at a site of damaged nerve tissue and applying a reduced pressure to the manifold thereby stimulating repair or regrowth of nerve tissue.

Abstract: This invention relates to biomaterials for directional tissue growth which comprise soluble fibres having a variable cross-sectional area which dissolve in a directional manner in situ, thereby controlling the direction and rate of formation of microchannels within the biomaterial and allowing vectored and timed channelling through the biomaterial. This may be useful, for example in directing the growth of blood vessels, nerves and other repair cells through the biomaterial in defined directions.

Abstract: Provided is an apparatus that includes a nerve conduit, a manifold and a support structure for providing a reduced pressure. Also provided is a system that includes a source of reduced pressure, a nerve conduit, a manifold, a support structure and a conduit for providing fluid communication between the manifold support and the source of reduced pressure. Additionally provided is a method that includes implanting the above nerve conduit, manifold and support structure at a site of damaged nerve tissue and applying a reduced pressure to the manifold thereby stimulating repair or regrowth of nerve tissue.

Abstract: Described are devices, methods and systems useful for achieving occlusion of vascular vessels. Percutaneous procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous reflux. Certain embodiments encompass the deployment and filling of an inflatable occlusion device via a percutaneous procedure, so as to occlude or obliterate a portion of a vascular vessel.

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 therebetween. 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: The medical articles which including the following: (a) a ceramic or metallic region whose surface includes a plurality of depressions, (b) a multilayer coating region including multiple polyelectrolyte layers deposited over the surface of the ceramic or metallic region; and (c) a therapeutic agent disposed beneath or within the multilayer coating region. According to another aspect of the present invention, medical articles are provided, which include: (a) a ceramic or metallic region, (b) a multilayer coating region including multiple polyelectrolyte layers deposited over a surface of the ceramic or metallic region, the multilayer coating region including a plurality of protuberances; and (c) a therapeutic agent disposed within regions beneath the protuberances. Also described herein are methods of making such medical articles, and methods of administering a therapeutic agent to a patent using such medical articles.

Abstract: Provided are an artificial dura mater having a laminated constitution of at least two layers of in vivo degradable polymers, at least one layer of them being a substrate layer, the substrate layer being formed of a lactic acid/glycolic acid/?-caprolactone copolymer, the copolymer having a component molar ratio of 60-85:3-15:10-30 mol % and the copolymer having an average chain length that satisfies the following expressions (1) to (3) and a process for the production thereof, and when this artificial dura mater is used, no liquid leakage is caused since the bloating of suture holes is small, and the period of time for which it retains its strength is suitably a little longer than the period of time required for the regeneration of an autodura mater, 2<L(LA)<[LA%/(LA%+GA%+CL%)]×X×0.058??(1) 1<L(GA)<[GA%/(LA%+GA%+CL%)]×X×0.58??(2) 1<L(CL)<[CL%/(LA%+GA%+CL%)]×X×0.

Abstract: This invention relates to highly porous scaffolding and methods of producing the same. Specifically, the scaffolding comprises a pore volume fraction of no less than 80% (v/v) of the total volume of the scaffold and interconnecting pores forming channels in the scaffold.

Abstract: It is intended to provide a method of preparing a decellularized soft tissue whereby swelling after an ultrahigh pressure treatment can be inhibited, etc. The above-described method of preparing a decellularized soft tissue comprises the application step wherein an ultrahigh hydrostatic pressure is applied to an isolated soft tissue in a medium to thereby disrupt cells in the soft tissue, and the removal step wherein the disrupted cells are removed. As the medium, use is made of an aqueous solution containing a water-soluble polysaccharide such as dextran.

Abstract: The present invention relates to an implant for stabilizing body tissue. The implant includes a core formed of a material which expands when contacted with liquid and a retainer which at least partially encloses the core.

Abstract: Biocompatible polyarylates of diphenol compounds and poly(alkylene oxide) dicarboxylic acids, articles formed therefrom and therapeutic uses are disclosed.