Abstract: The present invention provides novel compositions comprising multipotent cells or microvascular tissue, wherein the cells or tissue has been sterilized and/or treated to inactivated viruses, and related methods of using these compositions to treat or prevent tissue injury or disease in an allogeneic subject.

Abstract: This invention relates, e.g., to a Myocyte-based Flow Assist Device (MFAD) for treating a subject in need of increased flow of a biological fluid, such as venous blood or lymph, comprising a sheath which comprises rhythmically contracting myocytes.

Abstract: Systems and methods for preparing a tissue repair construct for a ligament reconstruction procedure using a reinforced whip-stitching are provided. The described techniques include passing a needle having suture tails attached thereto through a first surface of a graft at an origin point so that a portion of the suture tails exits on a second, opposite surface of the graft while a terminal length of the suture tails is maintained on the first surface of the graft. Multiple suture loops are formed by repeatedly passing the needle with the suture tails around opposite sides of the graft and through the first surface of the graft at subsequent entry points spaced apart along a length of the graft. Each loop is formed so that the construct is reinforced by having a terminal length of each of the suture tails disposed between the first surface of the graft and the loop.

Abstract: The present invention provides a method of bone regeneration for repairing a bone defect in a subject in need thereof. The method comprises the use of blood aspirate of the mandible bone marrow with the use of xenogen bone support.

Abstract: The present invention relates to shaped, bone fiber-based products and methods to make the same.

Abstract: Provided herein are methods of culturing organized skeletal muscle tissue from precursor muscle cells by cyclically stretching and relaxing said muscle cells on a support in vitro for a time sufficient to produce said organized skeletal muscle tissue, including reseeding said organized skeletal muscle tissue by contacting additional precursor muscle cells to said organized skeletal muscle tissue on said solid support, and then repeating said step of cyclically stretching and relaxing said muscle cells in said support in vitro for time sufficient to enhance the density (i.e., increased number of nuclei and/or number of multinucleated cells) of said organized skeletal muscle tissue on said support.

Abstract: Systems and methods for preparing a tissue repair construct for a ligament reconstruction procedure using a reinforced whip-stitching are provided. The described techniques include passing a needle having suture tails attached thereto through a first surface of a graft at an origin point so that a portion of the suture tails exits on a second, opposite surface of the graft while a terminal length of the suture tails is maintained on the first surface of the graft. Multiple suture loops are formed by repeatedly passing the needle with the suture tails around opposite sides of the graft and through the first surface of the graft at subsequent entry points spaced apart along a length of the graft. Each loop is formed so that the construct is reinforced by having a terminal length of each of the suture tails disposed between the first surface of the graft and the loop.

Abstract: Disclosed is a device for implantation into a bone void while minimising the potential for an increase in pressure within the bone void.

Abstract: Tissue products lacking a desired percentage of immunogenic epitopes, such as galactose alpha-1,3 galactose epitopes, are provided. Methods of making and using the tissue products are also provided.

Abstract: Systems and methods for preparing a ligament graft construct for a ligament reconstruction or repair procedure are provided. In general, the described techniques utilize a reinforcement material having at least one suture tail extending therefrom. The reinforcement material is a ribbon or a ribbon-like flattened portion attached to or integrally formed with the at least one suture tail. To prepare a tissue repair construct, the reinforcement material is positioned on a first surface of a graft to extend from an end thereof and the at least one suture tail, coupled to a needle, is repeatedly passed through the reinforcement material and the surface of the graft to a second surface of the graft, and around a side portion of the graft to thereby create multiple suture loops. The tissue repair construct can be formed on each end of the graft.

Abstract: The presently disclosed subject matter provides a scalable and electrostretching approach for generating microfibers exhibiting uniaxial alignment from polymer solutions. Such microfibers can be generated from a variety of natural polymers or synthetic polymers. The hydrogel microfibers can be used for controlled release of bioactive agents. The internal uniaxial alignment exhibited by the presently disclosed fibers provides improved mechanical properties to microfibers, contact guidance cues and induces alignment for cells seeded on or within the microfibers.

Abstract: The present invention relates to a tasseled cortical bone graft and a method of preparing cortical bone in thin strips or tubes then fully demineralizing it to give it formed flexibility and then creating a plurality of strands extending from one or more connection locations in the cortical bone in a fashion similar to a tassel.

Abstract: Systems and methods for preparing a tissue repair construct for a ligament reconstruction procedure using a reinforced whip-stitching are provided. The described techniques include passing a needle having suture tails attached thereto through a first surface of a graft at an origin point so that a portion of the suture tails exits on a second, opposite surface of the graft while a terminal length of the suture tails is maintained on the first surface of the graft. Multiple suture loops are formed by repeatedly passing the needle with the suture tails around opposite sides of the graft and through the first surface of the graft at subsequent entry points spaced apart along a length of the graft. Each loop is formed so that the construct is reinforced by having a terminal length of each of the suture tails disposed between the first surface of the graft and the loop.

Abstract: Provided are a scaffold material that functions as a scaffold material for two weeks or more in vivo and causes substantially no foreign-body reaction, and a method for producing the scaffold material. Specifically, a porous scaffold material comprising collagen fibers is provided.

Abstract: Implants having improved mechanical properties and/or degradation profiles, kits including such implants, and methods of producing and using the same.

Abstract: Described herein are tissue grafts produced by contacting dehydrated placental tissue grafts with a cross-linking agent. The tissue grafts described herein provide barrier and prevent the migration of a bioactive agent from the wound. Thus, the tissue grafts enhance wound healing while preventing the undesirable migration of a bioactive agent from the wound. Methods for making and using the cross-linked grafts are also described herein.

Abstract: Methods and devices for the repair of articular tissue using collagen material are provided. Compositions of collagen material and related kits are also provided.

Abstract: A flexor tendon repair device has a sheet of mesh material of rectangular shape with four edges: two longitudinal edges and two lateral edges perpendicular to the longitudinal edges. Each pair of edges is mutually parallel and spaced apart. Each edge is also folded inwardly for two smooth edges upon which the healing tendon rests and two smooth edges where the sheet mutually joins. Along with the sheet, the invention includes sutures, typically doubled, and one at each lateral edge. The lateral edges generally support the healing tendon while the sheet wraps around the tendon with the longitudinal edges generally parallel to the length of the tendon. A surgeon, during use of the invention, tightens each suture along the longitudinal edges, closing the device, and then upon the laterals to tie the suture. Upon tying, the mesh attains an ovoid shape similar to the natural cross section of a tendon.

Abstract: Anterior cruciate ligament reconstruction methods and devices are designed to achieve an anatomically accurate double bundle anterior cruciate ligament reconstruction by using a single femoral and tibial tunnel. The method and devices reconstruct the two bundles of the anterior cruciate ligament in a single femoral and tibial tunnel using a bone-patellar tendon-bone graft. The methods and devices enable an accurate anatomical reconstruction of the anteromedial and posterolateral bundles by creating a single femoral and tibial tunnel as opposed to creating two tunnels in the tibia and femur.

Abstract: The invention relates to implantable collagen devices made by seeding at least one elongate collagen construct, e.g., comprising at least one elongate synthetic collagen fiber with a plurality of cells and applying a strain and/or stress to the at least one elongate collagen fiber to induce the cells to differentiate into target phenotypes, e.g., tendon or ligament phenotype cells (and/or fibroblasts), typically with an extracellular matrix of collagen to organize into a tissue on the at least one collagen fiber.

Abstract: A fixation implant and associated methods are presented. The fixation implant includes a shaft extending from a first end portion to a second end portion and having an intermediate portion therebetween. The intermediate portion is generally smooth and the end portions are threaded. The method includes use of the fixation implant for repair of a metapodial phalangeal joint of a human extremity. The method includes: forming a bone tunnel in a bone; approximating material near the bone tunnel; and threading the fixation implant into the bone tunnel in interference fashion to secure the material relative to the bone tunnel. The fixation implant may be cut such that the end portion is flush with the bone.

Abstract: For the repair of a cartilage defect in a human or animal patient use is made of an implant comprising an implant body including a natural cartilage matrix and being coated with cells having a chondrogenic potential. These cells are produced by in vitro cell proliferation starting from chondrocytes isolated from a cartilage biopsy. The chondrocytes which are de-differentiated during cell proliferation are re-differentiated during tissue culturing and are in particular suitable for producing and maintaining the cartilage matrix of the implant body. The cells adhering to the surface of the implant body are preferably also chondrocytes being de-differentiated by cell proliferation, but not re-differentiated, and are therefore particularly suitable for integrating the implant in the defect. Due to the cells adhering to the surface of the implant body, the implant is successfully integrated in the viable tissue surrounding the defect.

Abstract: Degradable, polymeric fiber-based, three-dimensional braided scaffolds for use as graft materials in ligament and tendon repair, reconstruction and replacement are provided. Also provided are methods for preparing these scaffolds.

Abstract: A device for surgically coupling a soft tissue graft into a tunnel of a bone. The device includes a first member and a second member. The first member includes a first graft-engaging surface extending from a first end to a second end of the first member. The second member includes a second graft-engaging surface extending from a first end to a second end of the second member. The first graft-engaging surface and the second graft-engaging surface define a graft-accepting through-passage with a longitudinal axis extending therethrough when the first member is secured to the second member.

Abstract: One aspect of the present invention is a method of producing a decellularized composite tissue bioscaffold for musculoskeletal tissue interface reconstruction by physicochemically treating a musculoskeletal tissue interface isolated from allogeneic sources. In certain embodiments, such musculoskeletal tissue interfaces can also be isolated from xenogeneic sources. The method comprises treatment of the interface with detergents, chemical oxidants and ultrasonic energy, and wash steps in between to remove residual detergents as well as oxidants. The resulting bioscaffold may be freeze-dried or lyophilized, sterilized and aseptically packaged for subsequent use.

Abstract: A method of repairing soft tissue of a joint of a human extremity, such as a hand or foot. The method includes maintaining a metapodial bone intact; inserting a suture passing instrument into a space adjacent the metapodial and phalangeal bones; passing the suture through a volar ligament near a distal end of the metapodial bone and reattaching the volar ligament to the proximal phalanx. The method also includes making an incision on the dorsal aspect of the extremity to expose the dorsal aspect; inserting the distal portion of the suture passer instrument through the incision on the dorsal aspect of the extremity; inserting the distal portion of the suture passing instrument into a tendon sheath connected to a volar plate; and passing a portion of a suture through the volar plate.

Abstract: Methods and instruments for repairing soft tissues of a skeletal joint, such as, for example, of the foot or hand are presented. The method includes the steps of maintaining the metapodial bone intact; forming a bone tunnel through the proximal phalanx between volar and dorsal aspects of the proximal phalanx; passing a repair suture through the soft tissue to be repaired; passing the repair suture through the bone tunnel; and securing the suture. The method may be used for the repair of soft tissue, such as a volar ligament and/or a collateral ligament.

Abstract: Apparatus and methods for fixation of bone to bone, or soft tissue to bone. The apparatus comprises two fixation devices (for example, two buttons) joined by a biologic material (for example, a graft or tendon). Each fixation device is provided with at least one opening that allows the passage of the flexible material attached to the biologic material. The button may be formed, for example, of metal, PEEK or PLLA.

Abstract: The disclosure describes implantable medical products, that include dry or partially hydrated biocompatible constructs comprising collagen fibers configured to expand in situ after implantation to frictionally engage a bone tunnel wall to thereby affix the construct in the bone tunnel.

Abstract: It is described a construct for use in surgical repair of tendon. The construct contains at least one layer of human amnion and chorion tissues and is generally cylindrical with a C-shaped cross-section to allow for ease of implantation over the tendon. Methods for preparing the construct is described. In addition, an improved method for surgical repair of a damaged or diseased tendon using the construct is also described. The improved method reduces adhesions, scar formation, inflammation and risk of post-operative infection.

Abstract: A system and method for forming a bone construct include providing bone marrow stromal cells on a substrate without disposing the cells within an exogenous scaffold, and culturing the cells in vitro in osteogenic media such that the cells form a confluent monolayer and detach from the substrate to form a self-organized three-dimensional bone construct. A system and method for forming a ligament construct using fibrogenic media and a system and method for forming a functionally integrated bone-ligament construct are also provided.

Abstract: A system and method for forming a bone construct include providing bone marrow stromal cells on a substrate without disposing the cells within an exogenous scaffold, and culturing the cells in vitro in osteogenic media such that the cells form a confluent monolayer and detach from the substrate to form a self-organized three-dimensional bone construct. A system and method for forming a ligament construct using fibrogenic media and a system and method for forming a functionally integrated bone-ligament construct are also provided.

Abstract: An implant for orthopedic applications includes a quantity of flexible, elongated elements at least some of which possess connective tissue-healing activity, the elongated elements being arranged in substantially common alignment along their longitudinal axis.

Abstract: Biological tissues may be prepared for use in biological prostheses. The biological tissue may be fixated with glutaraldehyde and may be subjected to successive treatment of the tissue with a solution containing taurine to neutralize excess aldehyde groups that remain free after fixation.

Abstract: An implant including a substantially cohesive aggregate comprising bone-derived particles. Cohesiveness is maintained by a member of mechanical interlocking, engagement of adjacent bone-derived particles with one another through engagement with a binding agent, thermal bonding, chemical bonding, or a matrix material in which the bone-derived particles are retained. The aggregate is shaped as a one-dimensional or two-dimensional body.

Abstract: Described herein are tissue grafts derived from the placental tissue that are reinforced with at least one biocompatible mesh. The tissue grafts possess good adhesion to biological tissues and are useful in wound healing applications. Also described herein are methods for making and using the tissue grafts.

Abstract: A biocompatible ligament repair implant or scaffold device is provided for use in repairing a variety of ligament tissue injuries. The repair procedures may be conducted with ligament repair implants that contain a biological component that assists in healing or tissue repair. The biocompatible ligament repair implants include a biocompatible scaffold and particles of viable tissue derived from ligament tissue or tendon tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Abstract: A method and apparatus for fixing a ligament in a bone tunnel by cross-pinning the ligament in the bone tunnel.

Abstract: An instrument for placing a graft into a bone tunnel comprises an elongated shaft having a forked distal end comprising a pair of tines. A suture spans a space defined between the tines whereby the graft may be positioned between the tines and against the suture so as to be manipulated into the bone tunnel. The tendon folds about the suture, the suture having a releasable tension such that the instrument can be removed from the bone, leaving the tendon behind without the tendon hanging up on the suture.

Abstract: The present invention provides a novel split barbed fixation device for tenodesis, soft tissue reattachment of tendons and ligaments to bones. The insertion device is adapted for an entirely arthroscopic approach while achieving fixation strength with ultimate pullout resistance comparable to interference screws. The device includes an integrated tendon grasper that provides for easy manipulation of the tendon arthroscopically while eliminating the need for external whip stitching of the tendon, thereby reducing preparation time. The device further includes elements that prevent the fixation implant from being destabilized or rotating during deployment and manipulation, including: a depth limiting sheath, a first implant retainer, a first implant retaining step, a tendon grasping needle tube, and an implant keyway for mating the implant to the tube.

Abstract: The present invention relates to a bone-tendon-bone graft and components. Embodiments of the present invention comprise an intermediate bone block that is used to adjustably secure soft tissue (e.g., tendon) in a patient. Embodiments of intermediate bone blocks of the present invention are used singly or in combination with one or more bone blocks to form a bone block assembly for securing soft tissue. The present invention further relates to an assembled bone-tendon-bone graft for implantation in humans comprising the intermediate bone block and a length of soft tissue. A bone-tendon-bone graft comprises a length of soft tissue extending from a first assembled bone block to a second bone block and then doubles back to said first assembled bone block. Depending upon the embodiment, the second bone block fixedly or slideably attaches to the length of soft tissue and facilitates it doubling back to the first assembled bone block.

Abstract: A method for treating glutardialdehyde-stabilized biological tissue of animal or human origin, such as porcine, bovine pericardium or human cadaver heart valves, provides a physical plasma treatment of the, in particular, collagen tissue for increasing the biocompatibility, cell colonization and durability thereof.

Abstract: The present invention is directed to a composition comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. Also disclosed is a tissue graft or implant comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. The composition and/or tissue graft or implant of the invention is usable in combination with seeded cells, a tissue growth factor, and/or a chemotactic gent to attract a desired cell.

Abstract: The present disclosure provides an implantable medical device comprising a composite graft material including a first biologic component, such as an acellular tissue matrix, and a second non-biologic component.

Abstract: A biocompatible tissue graft is provided. The tissue graft includes an extracellular matrix patch that has a peripheral surface and at least one fiber stitched in a reinforcing pattern to mitigate tearing of the graft, improve the fixation retention of the graft, and/or limit cyclic stretching of the graft and substantially maintain these properties following partial enzymatic degradation of the graft while it remodels. The at least one fiber includes at least one free end that extends beyond the peripheral surface of the extracellular matrix for securing the patch to a host tissue.

Abstract: A biological nerve guide for implantation into a human body is made by providing a natural animal tissue membrane, crosslinking and fixing the membrane, minimizing the antigens from the membrane, tanning the membrane, coupling an active layer to an inner surface of the membrane, cutting the membrane into a desired shape and size, positioning the cut membrane onto a rod-shaped mold so that the cut membrane assumes a cylindrical configuration, and attaching a spiral support to the outer surface of the cut membrane.

Abstract: The present invention provides a method of performing anterior cruciate ligament replacement. Specifically, a graft tissue is harvested from a patient and single tunnels are prepared in each of the tibia and the femur of the patient. The graft is secured in the femoral tunnel and separated into an anterior cruciate medial bundle and a anterior cruciate posterior lateral bundle. The bundles are inserted through the tibial tunnel. During insertion the posterior lateral bundle is positioned in a posterior lateral position in the tibial tunnel while the anterior cruciate medial bundle is positioned in an anterior cruciate medial position in the tibial tunnel. The anterior cruciate medial bundle is then tensioned while the patient's knee is in approximately 90 degrees of flexion, and the posterior lateral bundle is tensioned while the patient's knee is approximately in full extension. Each of the bundles is then secured in the tibial tunnel.

Abstract: Methods of repairing a joint formed by at least two bone sections are provided wherein a biocompatible osteogenic band fabricated from an osteogenic biological material such as bone, tendon, ligament and collagen is affixed to two or more bone sections.

Abstract: A method and apparatus for fixing a ligament in a bone tunnel by cross-pinning the ligament in the bone tunnel.

Abstract: A graft construct formed of a plurality of single tendon strands or soft tissue grafts placed together so that at least a portion of one of the single tendon strands is wrapped around a portion of another of the single tendon strands by employing suturing, for example. The graft construct is provided with at least two regions, one region formed of at least a plurality of tendon strands tied together, and the other region formed of loose segments of the plurality of tendon strands.