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: Methods and systems are provided for fixating connective tissue to bone. Some aspects include a carrier member having a length, width, and thickness, wherein the length and width are each at least two times greater than the thickness; attachment members extending from the carrier member and that engage connective tissue of an animal; and a bone engaging member extending from the carrier member and configured to attach to a bone of the animal. In some aspects, when the attachment members are engaged with the connective tissue and the bone engaging member is attached to the bone, the connective tissue and the bone are limited in being pulled apart from one another during physiological use of the connective tissue.

Abstract: A surgical pin guide for reconstruction of a carpo-metacarpal (CMC) joint of a hand includes: a guide body having first and second opposed second end portions; a first pin receiving member connected to the first end portion of the guide body, the first pin receiving member having an elongated channel extending therethrough; and a second pin receiving member connected to the second end portion of the guide body, the second pin receiving member having an elongated channel extending therethrough. The first pin receiving member channel is sized and configured to receive a proximal end portion of a first pin that has a distal end portion residing in a trapezium of a hand. The second pin receiving member channel is sized and configured to receive and align a second pin for insertion into a first metacarpal of the hand.

Abstract: Surgical constructs and methods for tissue to bone repair employing a tissue construct reinforced with a reinforcement (reinforcing) material such as suture, tape, weave or mesh, among many others. The reinforced construct preferably includes a stitched reinforced region formed by employing a suture loop construct with a free floating needle that is attached to the suture loop, and also with a piece of material (a reinforcement or reinforcing material) attached to the suture loop. The reinforced construct may be attached to any fixation device and/or any bone tunnel.

Abstract: Embodiments of the present invention provide a cannulated screw driver assembly which includes a rigid guide pin such that the assembly can be used to assist the surgeon in inserting and positioning the rigid guide pin and an interference screw within a bone graft tunnel. Once the screw is properly placed, screw driver assembly components to include the rigid guide pin, the driver and the handle can be removed while the screw remains in the tunnel to secure the graft. In one embodiment, the interference screw can be removed from the distal end of the driver and the driver and handle can be removed from the screw's proximal end. Embodiments of the inventions also include an interchangeable driver to mate with different size and types of interference screws.

Abstract: A method for preparing a biological material for implanting provides irradiating at least a portion of the surface of the material with an accelerated Neutral Beam.

Abstract: The invention provides acellular tissue matrices made from collagen-containing tissues of animals genetically modified so as to be deficient in the galactose 1,3-galactose epitope and methods of making and using such acellular tissue matrices.

Abstract: A guide apparatus including a body having a proximal end, a distal end, a hole formed therethrough, and a central axis defined therethrough, and a projection member coupled to the distal end of the body. An outer diameter of the body is larger than an outer diameter of the projection member. Further, the projection member does not obstruct a pathway defined by the hole.

Abstract: A graft attachment apparatus including at least two separately formed filament loops, and a fixation member comprising at least one opening configured to receive the at least two separately formed filament loops. The at least two separately formed filament loops are coupled to the fixation member. Further, each of the at least two separately formed filament loops are continuous loops.

Abstract: An apparatus and method for performing a surgery, especially an ACL replacement surgery, where a flexible strand insertion rod co-operates with a U-Guide apparatus to insert a flexible strand into a tunnel formed in a bone portion and to guide a pair of drill points to form a pair of tunnels transversely to the tunnel of the insertion rod. The drill points are guided through the insertion rod and the flexible strand is held over the drill points as the transverse tunnels are formed. The insertion rod is then removed from the tunnels formed in the bone and the flexible strand is held looped over the second drill point. Subsequently, a soft tissue replacement is affixed to one end of the flexible strand and pulled over up to the first drill point with the other end of the flexible strand. The first drill point is then used to pull a cross pin through the transverse tunnel to hold the looped end of the soft tissue replacement in place.

Abstract: Implants for osteo and osteochondral repair have been developed. These implants include a series of channels between the upper and lower surfaces of the implants, such that when implanted the lower surfaces are situated in an area rich in bone marrow and the channels provide a means for the bone marrow to migrate through the implant. Preferably the implants are made from resorbable polymer fibers, preferably arranged in braids that are knitted or woven together such that the braids are substantially parallel with each other. The implants may be rolled into a bundle of braids with the axis of the braids substantially parallel to the axis of the bundle, to provide channels along the axis of the bundle. A preferred embodiment includes P4HB fibers braided and knitted into a structure that is coated with a ceramic, preferably physiologic calcium phosphate.

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 system and method for soft tissue to bone repair employing at least one suture anchor combined with at least one knotless fixation device. The method for soft tissue to bone fixation includes: (i) providing a first medial row constructed with a first plurality of fixation devices, at least one of the first plurality of fixation devices is an anchor; and (ii) providing a second lateral row constructed with a second plurality of fixation devices, at least one of the second plurality of fixation devices is a knotless fixation device, and suture or tape or allograft/biological component extending over the soft tissue and secured in place by the anchors in the first and second medial rows.

Abstract: A prosthetic anchor to be attached to a natural or prosthetic structure of a human or animal. The anchor includes a central layer with first and second surface. A plurality of fiber bundles, each with a medial portion, are concentrically embedded within the central layer to substantially define a horseshoe-shaped pattern. A substrate element is configured to be secured to the natural or prosthetic structure and to receive the second surface of the central layer. A securing element operably coupled to the second surface of the central layer is configured to secure the central layer to the substrate element in at least two positions.

Abstract: An implantable device is provided for soft-tissue or soft tissue-to-bone repair, fixation, augmentation, or replacement that includes a biomimetic and biodegradable nanofiber scaffold. Also provided is a fully synthetic implantable multiphased scaffold which includes, in a single continuous construct, a plurality of phases to mimic the natural anatomy of a tendon or ligament and their insertion sites. Also provided are scaffold apparatuses for musculoskeletal tissue engineering.

Abstract: Biocompatible coatings and spin finishes that can be applied to polyhydroxyalkanoate (PHA) polymers, and medical devices made from PHA polymers, have been developed. The coatings impart good lubricity to PHA polymers, particularly to fibers and braids made from these materials, making the coatings ideal for use on medical devices such as PHA braided sutures. The spin finishes can be applied to PHA fibers to facilitate their manufacture, and also for their conversion to other products, including medical textiles. The spin finishes serve to protect multifilament fiber bundles, and keep them intact following extrusion, and also to impart lubricity to the fiber bundles and monofilament fibers so that they are not damaged in subsequent processing steps particularly in textile processing. The coating reduces tissue drag of, for example, braided sutures.

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 agent to attract a desired cell.

Abstract: A system for single tunnel, double bundle anterior cruciate ligament reconstruction includes implant constructs and instruments. The implant constructs provide a combination of cortical fixation and bone tunnel aperture fixation. The implant constructs separate a graft into distinct bundles. The instruments are used to prepare shaped bone tunnels to receive the implant constructs and graft bundles. Methods for reconstructing the antero-medial and postero-lateral bundles of the anterior cruciate ligament may rely on single femoral and tibial tunnels and a single strand of graft.

Abstract: An arthroplasty device is provided having an interpenetrating polymer network (IPN) hydrogel that is strain-hardened by swelling and adapted to be held in place in a joint by conforming to a bone geometry. The strain-hardened IPN hydrogel is based on two different networks: (1) a non-silicone network of preformed hydrophilic non-ionic telechelic macromonomers chemically cross-linked by polymerization of its end-groups, and (2) a non-silicone network of ionizable monomers. The second network was polymerized and chemically cross-linked in the presence of the first network and has formed physical cross-links with the first network. Within the IPN, the degree of chemical cross-linking in the second network is less than in the first network. An aqueous salt solution (neutral pH) is used to ionize and swell the second network. The swelling of the second network is constrained by the first network resulting in an increase in effective physical cross-links within the IPN.

Abstract: Described herein are tissue grafts derived from the placenta that possess good adhesion to biological tissues and are useful in would healing applications. In one aspect, the tissue graft includes (1) two or more layers of amnion, wherein at least one layer of amnion is cross-linked, (2) two or more layers of chorion, wherein at least one layer of chorion is cross-linked, or (3) one or more layers of amnion and chorion, wherein at least one layer of amnion and/or chorion is cross-linked. In another aspect, the grafts are composed of amnion and chorion cross-linked with one another. In a further aspect, the grafts have one or more layers sandwiched between the amnion and chorion membranes. The amnion and/or the chorion are treated with a cross-linking agent prior to the formation of the graft. The presence of the cross-linking agent present on the graft also enhances adhesion to the biological tissue of interest. Also described herein are methods for making and using the tissue grafts.

Abstract: A soft tissue fixation system, most typically applicable to orthopedic joint repairs, such as anterior cruciate ligament (ACL) knee repair procedures, comprises an implant which is placeable in a tunnel disposed in a portion of bone, wherein the tunnel is defined by walls comprised of bone. A first member is deployable outwardly to engage the tunnel walls for anchoring the implant in place in the tunnel, and a second member is deployable outwardly to engage tissue material to be fixed within the tunnel. The second member also functions to move the tissue material outwardly into contact with the tunnel walls to promote tendon-bone fixation. Extra graft length is eliminated by compression of the tendon against the bone at the aperture of the femoral tunnel, which more closely replicates the native ACL and increases graft stiffness. The inventive device provides high fixation of tendon to bone and active tendon-bone compression.

Abstract: A component for satisfactorily plugging a bone tunnel formed in surgery such as ACL reconstruction by regenerating bone in a space portion of the bone tunnel (e.g., a bone tunnel for an arthroscope). The plug component is made of a calcium phosphate-based material, and includes a porous part having a porosity of 50 to 85%. The plug component has a cylindrical shape such that one of its end surfaces forms an angle of 30 to 60 degrees to its central axis.

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: The invention relates to a band-like structure for the augmentation of a ligament, comprising a central section for fastening to an organ of the true pelvis, said central section having a central knit fabric with a central warp direction, a lateral section for fastening to a suspension surface and a plurality of threads, which are connected to the central section and the lateral section. It is proposed that the central knit fabric comprises the plurality of threads.

Abstract: Various embodiments are directed to femoral and tibial bases that form structures of an implantable mechanical energy absorbing system. A bone facing surface of each type of base has a main surface portion and a plurality of protrusions extending from the main surface portion. The base can be attached to a bone so that the main surface portion is disposed in contact with but not penetrating into soft tissue at a substantially uniform distance from the bone.

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

Abstract: The present invention relates generally to methods for preparing a dual tendon bundle that is useful as a replacement ligament or tendon graft for, for example, anterior cruciate ligament (ACL) reconstruction. More particularly, the dual tendon bundle prepared according to the present invention has a functional cross section diameter and/or a minimum length that meets or exceeds the standard requirements for replacement ligament or tendon grafts. The present invention further relates to the dual tendon bundle prepared by the disclosed methods and packages comprising the same. Methods of using the dual tendon bundle prepared according to the present invention by providing the dual tendon bundle thus obtained for implanting into a patient in need thereof are also provided.

Abstract: Disclosed is a device and method for repairing a partially or totally ruptured tendon. The device comprises an implant placed inside or outside of the tendon on either side of the rupture in order to strengthen the ruptured area during repair. Once positioned inside the tendon, the tendon is held in place so it can heal either by sewing or stapling through the tendon and implant, or by any other suitable method that utilizes the implant to provide strength to the ruptured area. In this manner the tendon can heal with less chance of rupturing again prior to healing.

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: A buckle useful for cortical fixation has a graft retention loop slidably affixed thereto for movement from a first position adjacent a first end of the buckle to a second position at about the midpoint of the buckle. The buckle, with a graft over the loop, is drawn up lengthwise through a bone tunnel through a tibia and then flipped sideways to rest against the surface of the bone with the loop and graft depending back into the tunnel. The sliding attachment of the loop permits flipping of the buckle minimizes the flipping distance, which is the excess amount of the loop which must be pulled free of the tunnel to allow the buckle to be flipped sideways.

Abstract: A facet joint prosthesis for replacing a facet joint comprising superior and inferior facets, the prosthesis comprising: a) a superior facet joint component forming a superior endplate having a superior outer surface adapted to attach to the superior facet and an inner surface, b) an inferior facet joint component forming an inferior endplate having an inferior outer surface adapted to attach to the inferior facet and an inner surface, and c) a ligament adapted to constrain relative movement between the facets, wherein the ligament comprises an elastic core having a superior surface adapted to attach to the inner surface of the superior facet joint component and an inferior surface adapted to attach to the inner surface of the inferior facet joint component.

Abstract: A method and device for finding isometric points in the joints of mammals for use in surgical repair of a joint. Isometric points are first identified in radiographic or other two dimensional images and then located in the actual joint. A method for repairing a cruciate ligament-deficient canine stifle employing the method and device for finding isometric points is described. A method and apparatus for locating the axis of rotation of a joint is also described.

Abstract: A fixation device for securing a transplant in a bone tunnel, having a strap with a plurality of protrusions disposed along its length, a fastening member with an aperture therein for passing the strap, and a connection element disposed at a distal end of the strap for engaging a transplant is provided. The fixation device is configured such that, when the distal side of the fastening member lies substantially flush against an outer surface of the bone, a longitudinal axis of the aperture is substantially parallel to a longitudinal axis of the bone tunnel. A method for securing a transplant in a bone tunnel using the aforementioned fixation device is also provided.

Abstract: Implantable assemblies/devices and methods are provided for manipulating energy transferred by members defining an articulating anatomical joint, wherein the members collectively define a path of motion. Assemblies/devices are provided with a first component configured to be attached to a first anatomical member of the anatomical joint, a second component configured to be attached to a second anatomical member of the anatomical joint; and a tension member joining the first and second components. The tension member is placed under tension to absorb energy transferred by the anatomical members when the first component is attached to the first anatomical member and the second component is attached to the second anatomical member and a distance between locations of attachment of the first and second components becomes smaller then an implant-defined distance between the locations.

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: Described herein are methods and devices for use in repair of a patient's anterior cruciate ligament (ACL). These methods (and devices for performing them) allow the repair, rather than merely replacement, of the ACL. For example, described herein are anchoring devices that may be inserted into a bone and may anchor a scaffolding/support (e.g., graft) material within the bone so that the torn or damaged end of the ACL may be secured to the scaffolding/support material within the femoral notch. These anchoring devices and method of using them are particularly well suited for use with the continuous suture passers described herein, since these suture passers may allow access to previously inaccessible regions of the knee (or other body regions).

Abstract: An apparatus for anchoring at least two graft ligaments within a longitudinal bone tunnel includes a longitudinal sleeve having at least two radially spaced ligament-contacting surfaces located in lateral opposition to a sleeve inner lumen. The sleeve is configured for at least partial insertion into the bone tunnel with each graft ligament positioned laterally adjacent a different ligament-contacting surface. The graft ligaments are at least partially located between the bone tunnel and the sleeve. An actuating member has longitudinally separated proximal and distal actuating member ends. An asymmetrically offset profile is defined by at least one of the sleeve and the actuating member. The asymmetrically offset profile has a plurality of longitudinally spaced engagement thresholds. The actuating member is inserted longitudinally into the sleeve to cause frictional engagement of each graft ligament with both the bone tunnel and at least one ligament-contacting surface.

Abstract: Disclosed are medical devices and methods for tendon, ligament, and soft tissue repair. A method includes introducing a first segment having a delivery assembly into a first soft tissue, and removing the delivery assembly to expose an opening of a hollow body of the first segment. The method also includes introducing a second segment having a second delivery assembly and a second body into a second soft tissue, guiding the second delivery assembly through the opening, and advancing the second body into the hollow body, thereby joining the first soft tissue and the second soft tissue.

Abstract: An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

Abstract: Apparatus for use in supporting a graft ligament within a bone tunnel, the apparatus comprising a graft ligament plug, the graft ligament plug comprising a groove extending along one side of the plug, across the front end of the plug, and then back down the opposing side of the plug, with the groove being sized such that when a graft ligament is disposed in the groove, the graft ligament will protrude out of the groove and engage adjoining portions of the bone tunnel so as to facilitate osseointegration therewith; wherein the graft ligament plug is formed in two opposing halves, such that the graft ligament can be positioned within the groove and thereafter clamped between the opposing two halves of the graft ligament plug when the two opposing halves are brought together so as to form the complete graft ligament plug.

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: Devices and methods for treating defects in connective tissue are provided along with methods for making such devices. The devices can include acellular arterial tissue matrices that facilitate regrowth of the damaged tissue.

Abstract: Disclosed are medical devices and methods for tendon, ligament, and soft tissue repair. A method includes introducing a first segment having a delivery assembly into a first soft tissue, and removing the delivery assembly to expose an opening of a hollow body of the first segment. The method also includes introducing a second segment having a second delivery assembly and a second body into a second soft tissue, guiding the second delivery assembly through the opening, and advancing the second body into the hollow body, thereby joining the first soft tissue and the second soft tissue.

Abstract: A system and method for soft tissue to bone repair employing at least one suture anchor combined with at least one knotless fixation device. The method for soft tissue to bone fixation includes: (i) providing a first medial row constructed with a first plurality of fixation devices, at least one of the first plurality of fixation devices is an anchor; and (ii) providing a second lateral row constructed with a second plurality of fixation devices, at least one of the second plurality of fixation devices is a knotless fixation device, and suture or tape or allograft/biological component extending over the soft tissue and secured in place by the anchors in the first and second medial rows.

Abstract: A soft tissue fixation system, most typically applicable to orthopedic joint repairs, such as anterior cruciate ligament (ACL) knee repair procedures, comprises an implant which is placeable in a tunnel disposed in a portion of bone, wherein the tunnel is defined by walls comprised of bone. A first member is deployable outwardly to engage the tunnel walls for anchoring the implant in place in the tunnel, and a second member is deployable outwardly to engage tissue material to be fixed within the tunnel. The second member also functions to move the tissue material outwardly into contact with the tunnel walls to promote tendon-bone fixation. Extra graft length is eliminated by compression of the tendon against the bone at the aperture of the femoral tunnel, which more closely replicates the native ACL and increases graft stiffness. The inventive device provides high fixation of tendon to bone and active tendon-bone compression.

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: An apparatus and method is disclosed for performing a surgery, such as an orthopedic surgery. The apparatus can include a guide portion and an alignment portion. The guide portion can assist in positioning the alignment portion to assist in aligning an implant. The implant can be aligned and positioned to hold a graft relative to a bone portion.

Abstract: Positioning instruments and related methods are described for implanting an energy absorbing system for treating joints. The positioning instruments and methods allow the energy absorbing system to be positioned at a joint such that the desired motion will occur for the particular design of a particular energy absorbing system which is to be implanted. The positioning instruments include a locating instrument for locating an anatomical feature and a target location for implantation of the energy absorbing system, a verification instrument for verification of the target location, a placement guide for guiding placement of a part of the energy absorbing system, and positioning device for aligning portions of the energy absorbing system.

Abstract: Positioning instruments and related methods are described for implanting an energy absorbing system for treating joints. The positioning instruments and methods allow the energy absorbing system to be positioned at a joint such that the desired motion will occur for the particular design of a particular energy absorbing system which is to be implanted. The positioning instruments include a locating instrument for locating an anatomical feature and a target location for implantation of the energy absorbing system, a verification instrument for verification of the target location, a placement guide for guiding placement of a part of the energy absorbing system, and positioning device for aligning portions of the energy absorbing system.

Abstract: Distensible ligaments and distensible ligament systems are provided, including apparatuses, systems, devices, hardware, methods, and combinations for distensible systems.