Abstract: Provided herein is a 3D printing system and related compositions, and method of using such, that can produce a polymeric microfiber having embedded microspheres encapsulating an active agent with micron precision and high spatial and temporal resolution. One aspect of the present disclosure provides a method of forming a biocompatible scaffold. Another aspect provides a method of forming a polymeric fiber having a microencapsulated agent distributed in the polymeric fiber. Another aspect provides a composition including a polymeric microfiber produced by 3D printing.

Abstract: Certain small molecule amino acid phosphate compounds such as phosphoserine and certain multivalent metal compounds such as calcium phosphate containing cements have been found to have improved properties and form an interpenetrating network in the presence of a polymer that contains either an electronegative carbonyl oxygen atom of the ester group or an electronegative nitrogen atom of the amine group as the bonding sites of the polymer surfaces to the available multivalent metal ions.

Abstract: An implant having a preferably hollow cylindrical basic structure. A nonwoven fabric is disposed in and/or on the basic structure, the nonwoven fabric preferably comprising biocompatible thermoplastic polyurethane and/or a polymer selected from the group consisting of polylactic acid; polycaprolactone, and a copolymer thereof, and/or a polymer including polyphosphazene. At least in at least one section of the implant, preferably at the proximal and/or distal ends of the implant, fastening means are provided or the nonwoven fabric is treated such that, at least in the expanded state of the implant, the protrusion of nonwoven fabric sections from the implant is significantly reduced. Furthermore, a method for producing such an implant is provided.

Abstract: Meniscal extrusion can occur due detachment of the knee capsule from structures of the knee. Disclosed herein are methods to repair the meniscal detachment. Additionally, cadaveric and synthetic models can be used to teach said methods of repair.

Abstract: A reinforced graft construct for repairing a tendon or ligament formed by inserting a piece of material, such as suture, through the graft lengthwise. The material may be inserted along only a portion of the graft or along the entire graft. The material may be a reinforcement (reinforcing) material such as suture, tape, weave, or mesh passed lengthwise through the graft (for example, along the center of the graft). The ends of the graft may be whipstiched to provide additional fixation when implanted. The material may be bioabsorbable such that it will resorb away after a period of time in the body.

Abstract: A culture media, media supplement, or soluble matrix for cryopreservation or enhanced regenerative cell growth in culture and maintenance of multi-lineage differentiation potentiation. The inventive culture media, media supplement, or soluble matrix comprises a GAG composition comprising a sulfated GAG, such as chondroitin sulfate. A soluble matrix, a cell administration package or kit comprising the soluble matrix and a device for cell administration, and a method of use thereof, for administration of regenerative cells for treating a joint disease or other weakened or damaged tissue comprising the specified GAG compositions are further provided.

Abstract: A soft tissue repair assembly. The assembly includes a flexible member having first and second ends, and a strand passing through the flexible member. The strand has first and second strand ends extending through the flexible member, such that pulling at least one of the first and second strand ends changes the flexible member from a first shape suitable for insertion through soft tissue to a second shape suitable for securely lodging the soft tissue repair assembly relative to soft tissue.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A surgical device and method is used in attaching a tendon or a ligament to bone. In a preferred form, the device is a crimp configured to reduce the thickness of the free end of the tendon or the ligament to facilitate insertion of the tendon or the ligament into an opening formed in the bone.

Abstract: A graft ligament anchor includes a tubular body having a bore therethrough and proximal and distal ends. A flange is attached to the tubular body at the proximal end thereof and extends radially outwardly beyond the tubular body. A deformable wall is disposed in the tubular body bore and defines, at least in part, a chamber for retaining the graft ligament therein. An expansion device is configured for insertion into the tubular body axially of the tubular body, and for impinging upon the deformable wall to press the deformable wall, and hence the graft ligament received in the chamber, toward a wall of the bore, whereby to fix the graft ligament in the tubular body.

Abstract: A graft fixation device (1) comprising a sheath (2) having a body (9) that defines an inner longitudinal bore (8) and a member (3) for receipt within said bore (8), wherein said sheath (2) comprises at least one projection (15) moveably connected to said sheath body (9) and said at least one projection (15) is arranged so as to be displaceable radially outwardly of said sheath body (9) upon receipt of said member (3) within said bore (8).

Abstract: Various methods and devices are provided for a graft fixation device for fixing a graft member within a bone tunnel. In one embodiment, a graft fixation device is provided having a radially expandable sheath adapted to be disposed within a bone tunnel, and a sheath expander adapted to be received within the radially expandable sheath to expand the sheath and thereby anchor a graft between the sheath and the bone tunnel. In an exemplary embodiment, the graft fixation device is particularly useful to affix a graft within a femoral tunnel.

Abstract: Sheaths for implantable fixation devices are disclosed. Sheaths have a flexible body with a perforated wall, an open end, a closed end, and a body interior sized and shaped to receive the fixation device.

Abstract: Soft tissue grafts and methods for making and using them are presented. The graft includes an intermediate portion and a reduced area end portion.

Abstract: An implant for repairing a joint between a first bone and a second bone includes a first section constructed of a substantially rigid material and a graft constructed of soft tissue having a first end and a second end. The first section has a first end surface configured for positioning against the first bone. The graft is configured for stabilizing the first section relative to the first bone. A first fastener is configured for mounting to the graft and the first section to anchor the graft to the first section. A second fastener is configured for mounting to the graft and the first bone to anchor the graft to the first bone.

Abstract: Methods for drilling an angled osteal tunnel into a bone by drilling or punching at least one first tunnel portion into the bone from a first surface location on the bone, the at least one first tunnel portion having an interior end within the bone and then drilling or punching at least one second tunnel portion into the bone from a second surface location on the bone using a guide component to guide a drill to the interior end of the first tunnel portion, whereby the at least one first tunnel portion and the at least one second tunnel portion intersect and connect at an angle, resulting in an angled osteal tunnel.

Abstract: A graft ligament anchor comprises a graft ligament engagement member disposed in an opening in a bone, the graft ligament engagement member being arranged to receive a graft ligament alongside the engagement member, and a locking member for disposition in the opening, and at least in part engageable with the graft ligament engagement member. Movement of the locking member in the opening causes the locking member to urge the engagement member, and the graft ligament therewith, toward a wall of the opening, to secure the graft ligament to the wall of the opening. A method for attaching a graft ligament to a bone is also provided.

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: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A surgical device and method is used in attaching a tendon or a ligament to bone. In a preferred form, the device is a crimp configured to reduce the thickness of the free end of the tendon or the ligament to facilitate insertion of the tendon or the ligament into an opening formed in the bone.

Abstract: A surgical device for assisting in the repair and rehabilitation of a tendon, formed of a cylindrical, helically wound braid (similar to a “Chinese finger trap”). The device may be implantable, and configured to enclose the repair site of the severed tendon. As tension or pull is applied to the tendon, the device tightens to secure the repair site. The device may improve mobility and use of the tendon by providing stability to the repair site, improving glide through the tendon sheath, allowing diffusion of nutrients to the repair site, and/or reducing adhesions within the tendon sheath.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A graft ligament anchor comprises a graft ligament engagement member disposed in an opening in a bone, the graft ligament engagement member being arranged to receive a graft ligament alongside the engagement member, and a locking member for disposition in the opening, and at least in part engageable with the graft ligament engagement member. Movement of the locking member in the opening causes the locking member to urge the engagement member, and the graft ligament therewith, toward a wall of the opening, to secure the graft ligament to the wall of the opening.

Abstract: A ligament incorporated into a prosthetic joint exhibiting a plasticized, elongated and deformable material. A fibrous material is internally disposed within the deformable material, the fibrous material terminating in first and second enlarged bead portions arranged in proximity to enlarged pocket defined ends associated with the deformable materials. First and second bones define a joint region therebetween, the deformable end pockets and bead portions being inserted through associated holes defined in joint proximate locations associated with the bones, so that actuation of a projection location of the fibrous material causes the bead portions to outwardly deflect the end pockets, resulting in the ligaments being anchored in place between the bones.

Abstract: A ligament incorporated into a prosthetic joint exhibiting a plasticized, elongated and deformable material. A fibrous material is internally disposed within the deformable material, the fibrous material terminating in first and second enlarged bead portions arranged in proximity to enlarged pocket defined ends associated with the deformable materials. First and second bones define a joint region therebetween, the deformable end pockets and bead portions being inserted through associated holes defined in joint proximate locations associated with the bones, so that actuation of a projection location of the fibrous material causes the bead portions to outwardly deflect the end pockets, resulting in the ligaments being anchored in place between the bones.

Abstract: A graft ligament anchor comprises a graft ligament engagement member disposed in an opening in a bone, the graft ligament engagement member being arranged to receive a graft ligament alongside the engagement member, and a locking member for disposition in the opening, and at least in part engageable with the graft ligament engagement member. Movement of the locking member in the opening causes the locking member to urge the engagement member, and the graft ligament therewith, toward a wall of the opening, to secure the graft ligament to the wall of the opening.

Abstract: Sheaths for implantable fixation devices are disclosed. Sheaths have a flexible body with a perforated wall, an open end, a closed end, and a body interior sized and shaped to receive the fixation device.

Abstract: A material fixation system is particularly adapted to improve the tendon-to-bone fixation of hamstring autografts, as well as other soft tissue ACL reconstruction techniques. The system is easy to use, requires no additional accessories, uses only a single drill hole, and can be implanted by one person. Additionally, it replicates the native ACL by compressing the tendons against the aperture of the tibial tunnel, which leads to a shorter graft and increased graft stiffness. It is adapted to accommodate single or double tendon bundle autografts or allografts. It also provides pull out strength measured to be greater than 1000 N.

Abstract: A graft ligament anchor includes a tubular body having a bore therethrough and proximal and distal ends. A flange is attached to the tubular body at the proximal end thereof and extends radially outwardly beyond the tubular body. A deformable wall is disposed in the tubular body bore and defines, at least in part, a chamber for retaining the graft ligament therein. An expansion device is configured for insertion into the tubular body axially of the tubular body, and for impinging upon the deformable wall to press the deformable wall, and hence the graft ligament received in the chamber, toward a wall of the bore, whereby to fix the graft ligament in the tubular body.

Abstract: The invention provides a ligament or tendon prosthesis. The prosthesis has at least two load bearing elements (6a, 6b) arranged in series and having different mechanical properties. The invention also provides a method for producing the prosthesis of the invention, as well as a method for replacing a torn or damaged ligament or tendon.

Abstract: An orthopedic implant device is non-rigid, i.e., flexible and/or malleable, in a first form for insertion into a desired in vivo site, and then transformable into a rigid, or hardened, form for providing a load-bearing function or providing other structural and/or mechanical function after implant. The device includes a biocompatible sheath and a curable material sealed within the sheath. The curable material is provided in a first form that provides flexibility to the device and is structured to rigidize in a second form after insertion to an in vivo location as a result of application of a cure-initiating energy to the material prior to insertion. Related methods and kits are also provided.

Abstract: An implantable tendon protection system includes a body adapted to be implanted within a bursa overlying a tendon of a patient to protect the tendon. The body may be fixed to the tendon with adhesive, sutures, staples, and/or anchors. A surgical kit is provided with such a tendon protection system and an insertion cannula. Methods of protecting a tendon of a patient are also disclosed.

Abstract: Sheaths for implantable fixation devices and methods of using the sheaths are disclosed. Sheaths have a flexible body with a perforated wall, and an interior of the body is sized and shaped to receive the fixation device. Sheaths include a plurality of flexible or inflexible tubes arranged to form a ring, where the central cavity defined by the ring is sized and shaped to receive the fixation device.

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 sheath for organizing soft tissue includes a first tube having a flexible body sized and shaped to receive a fixation device, and a second tube coupled to the first tube having a flexible body sized and shaped to receive a soft tissue graft. A method for implanting soft tissue in a bone tunnel includes coupling a soft tissue graft to a sheath assembly; and positioning the sheath assembly relative to the soft tissue graft based on a measured depth of a bone tunnel. A set of surgical devices for implanting soft tissue grafts in a bone tunnel includes a sheath assembly, a measurement device for measuring the depth of the bone tunnel, a securing element configured to secure the sheath assembly to the soft tissue graft at a position determined by the measured bone tunnel depth, and a tensioning device configured to organize a plurality of soft tissue grafts.

Abstract: Sheaths for implantable fixation devices and methods of using the sheaths are disclosed. Sheaths have a flexible body with a perforated wall, and an interior of the body is sized and shaped to receive the fixation device. Sheaths include a plurality of flexible or inflexible tubes arranged to form a ring, where the central cavity defined by the ring is sized and shaped to receive the fixation device.

Abstract: The present invention has multiple aspects relating to assembled self fixing bone-tendon-bone (BTB) grafts and BTB implants. A preferred application in which self fixing assembled bone-tendon-bone (BTB) grafts and implants of the present technology can be used is for ACL repairs in a human patient. In one embodiment, a self fixing BTB graft is characterized by the presence of threads along at least a portion of the exterior surface of one or both bone blocks. In another embodiment, a self fixing assembled bone-tendon-bone implant comprises a removable tendon tensioner which imparts a predetermined tension on the tendon of the BTB graft.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: Various embodiments are directed to a sheath for covering one or more components of an extra-articular implantable mechanical energy absorbing system. The sheath is generally an elongated structure having an inner space extending the length thereof. In use, the sheath can exclude the energy absorbing system from surrounding tissue and facilitate creating a capsule for its operation. Materials and dimensions are selected to achieve these purposes. The ends of the sheath include various attachment mechanisms for securing the sheath to one or more components of an extra-articular implantable mechanical energy absorbing system.

Abstract: A graft ligament anchor comprises a ligament engagement member in the form of an expandable elastomeric sleeve of substantially cylindrical shape for disposition in an opening in a bone alongside of a portion of a ligament, and a locking member for disposition in the engagement member . Movement of the locking member in the engagement member causes the locking member to expand the engagement member and thereby urge, the ligament toward a wall of the opening so as to secure the ligament to the wall. A method for attaching a graft ligament to a bone comprises providing an opening in the bone, inserting the ligament and a ligament engagement member in the opening, with the ligament disposed alongside the engagement member, inserting a locking member in the engagement member and moving the locking member to engage the engagement member to urge the engagement member, and the ligament, toward a wall of the opening to secure the ligament to the wall.

Abstract: Sheaths for implantable fixation devices and methods of using the sheaths are disclosed. Sheaths have a flexible body with a perforated wall, and an interior of the body is sized and shaped to receive the fixation device. Sheaths include a plurality of flexible or inflexible tubes arranged to form a ring, where the central cavity defined by the ring is sized and shaped to receive the fixation device.

Abstract: Sheaths for implantable fixation devices and methods of using the sheaths are disclosed. Sheaths have a flexible body with a perforated wall, and an interior of the body is sized and shaped to receive the fixation device. Sheaths include a plurality of flexible or inflexible tubes arranged to form a ring, where the central cavity defined by the ring is sized and shaped to receive the fixation device.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A graft ligament anchor comprises a graft ligament engagement member disposed in an opening in a bone, the graft ligament engagement member being arranged to receive a graft ligament alongside the engagement member, and a locking member for disposition in the opening, and at least in part engageable with the graft ligament engagement member. Movement of the locking member in the opening causes the locking member to urge the engagement member, and the graft ligament therewith, toward a wall of the opening, to secure the graft ligament to the wall of the opening.

Abstract: A radially expandable sheath is provided having a substantially closed distal end with at least two sidewalls extending proximally therefrom and defining a central lumen. Each sidewall can have a substantially concave outer surface adapted to seat a graft member, and each side wall is at least partially separated by a longitudinally oriented slot that extends from a proximal end along a substantial length of each sidewall. The slot preferably terminates at a position just proximal to the distal end. The device can also include a sheath expander that is adapted to be disposed in the central lumen of the radially expandable sheath and that is configured to flex the sidewalls to radially expand the sheath so as to fix a graft member within a bone tunnel.

Abstract: A sheath for organizing soft tissue includes a first tube having a flexible body sized and shaped to receive a fixation device, and a second tube coupled to the first tube having a flexible body sized and shaped to receive a soft tissue graft. A method for implanting soft tissue in a bone tunnel includes coupling a soft tissue graft to a sheath assembly; and positioning the sheath assembly relative to the soft tissue graft based on a measured depth of a bone tunnel. A set of surgical devices for implanting soft tissue grafts in a bone tunnel includes a sheath assembly, a measurement device for measuring the depth of the bone tunnel, a securing element configured to secure the sheath assembly to the soft tissue graft at a position determined by the measured bone tunnel depth, and a tensioning device configured to organize a plurality of soft tissue grafts.

Abstract: A graft ligament anchor comprises a graft ligament engagement member disposed in an opening in a bone, the graft ligament engagement member being arranged to receive a graft ligament alongside the engagement member, and a locking member for disposition in the opening, and at least in part engageable with the graft ligament engagement member. Movement of the locking member in the opening causes the locking member to urge the engagement member, and the graft ligament therewith, toward a wall of the opening, to secure the graft ligament to the wall of the opening.

Abstract: A connective tissue scaffold including opposed first and second anchoring segments formed from a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to a longitudinal axis of the scaffold and a plurality of bioresorbable polymeric fibers oriented in a direction substantially transverse to a longitudinal axis of the scaffold. A central segment joins the first and second anchoring segments and includes a plurality of bioresorbable polymeric fibers oriented in a direction substantially parallel to the longitudinal axis of the scaffold. The scaffold can also a tissue particle and/or biological component.