Abstract: An apparatus and method are provided for a syndesmosis treatment construct configured to be placed into a cinched configuration that presses a first bone against a second bone. The syndesmosis treatment construct comprises a proximal fixator to contact the first bone and a distal fixator to contact the second bone. A first suture and a second suture are parallelly looped through the distal fixator. A free splice slidably rides on proximal ends and distal ends of both of the first and second sutures. The distal ends are looped through the proximal fixator and bound within a stitch splice. The proximal ends are passed outside of the stitch splice and through the proximal fixator. The free splices compress and seize the proximal ends during pulling of the proximal ends by a practitioner so as to maintain the cinched configuration.

Abstract: Aspects of the disclosure relate methods and synthetic scaffolds for regenerating gastrointestinal tissue (e.g., esophageal tissue).

Abstract: A method of reinforcing a biological construct according to an exemplary aspect of the present disclosure includes, among other things, attaching a suture loop/needle construct to a reinforcement material and stitching the reinforcement material to a biological construct to form a reinforced biological construct. The reinforcement material is attached to the suture loop/needle construct prior to approximating the reinforcement material to the biological construct.

Abstract: A graft retention device has an elongated body with first and a second ends, and a midpoint therebetween. A pair of elongated slots through the body defines a tang therebetween. At least one of the slots have an open first end into the body at the body first end such that the first end is closed via a retention line between the tang and the body. A graft retention loop disposed over the tang is slidable therealong from a first position closer to the body first end and a second position closer to the midpoint.

Abstract: Connective tissue-to-bone interface scaffolds (e.g., ligament-to-bone interface scaffolds, tendon-to-bone interface scaffolds, etc.). These scaffolds may be a single integrated implant or may be a modular (e.g., two-part) implant system.

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: An artificial ligament prosthesis which is notable in that it comprises a layer totally or partly consisting of PCL fibres. The ligament prosthesis is a biodegradable and “biointegrable” artificial ligament which makes it possible to take away all the apprehensions and uncertainties due to non-degradable synthetic supports. It is a prosthetic structure inspired by and similar to the native tissue, which is biodegradable while being sterilisable. It can optionally be seeded in order to facilitate the formation of functional tissues with controlled cell and tissue activity, having the required mechanical properties. The prosthesis maybe slowly resorbable in order to be gradually replaced with a functional tissue identical to that of the native ligament.

Abstract: Methods and apparatuses for repairing a tear in soft tissue are disclosed. A method according to the principles of the present disclosure includes connecting an intermediate member to a bone anchor and placing the intermediate member on the soft tissue. The method further includes inserting a first suture through the intermediate member and the soft tissue to attach the intermediate member to the soft tissue and fixing the bone anchor to bone to secure the soft tissue to the bone.

Abstract: A method of reinforcing a biological construct according to an exemplary aspect of the present disclosure includes, among other things, attaching a suture loop/needle construct to a reinforcement material and stitching the reinforcement material to a biological construct to form a reinforced biological construct. The reinforcement material is attached to the suture loop/needle construct prior to approximating the reinforcement material to the biological construct.

Abstract: Methods and devices for the repair of a ruptured ligament using a scaffold device are provided. Aspects of the invention may include a scaffold attached by a suture to an anchor. In aspects of the invention, the anchor may be secured to a bone near or at the repair site.

Abstract: A reconstruction system and associated techniques for soft tissue repairs and repair augmentation. The reconstruction system is an internal soft tissue brace formed of at least one fixation device (for example, anchors or screws) and a replacement/reinforcement construct (for example, a suture construct in the form of a suture tape such as FiberTape® or a collagen tape or a suture with biological material or a collagen coated material, or a collagen patch, or a biological construct such as Arthroflex). The reinforcement construct and fixation devices may be used as a suture repair alone (to replace the ligament or tendon), or in conjunction with other traditional soft tissue repair procedures, acting as a reinforcement system for the repaired soft tissue.

Abstract: A medical device for implantation in a hip joint of a patient is provided. The medical device comprises a prosthetic caput femur having least partially spherical portion and a releasing member. The releasing member is adapted to, in a first state, restrain the at least partially spherical portion in an acetabulum or a prosthetic acetabulum and, in a second state, to release the at least partially spherical portion from the acetabulum or the prosthetic acetabulum. The releasing member is further adapted to change from the first state to the second state and from the second state to the first state when a strain, exceeding a predetermined threshold, is exerted on the hip joint.

Abstract: Methods and devices for the repair of a ruptured ligament using a scaffold device are provided. Aspects of the invention may include a scaffold attached by one or more sutures to one or more anchors. In aspects of the invention, the anchors may be secured to a bone near or at the repair site.

Abstract: An apparatus and a method are provided for performing cartilage graft implant surgeries. The apparatus comprises a graft plug kit comprising one or more grafts configured to treat osteochondral defects in various bone joint locations in a patient's body. Each of the grafts comprises a cartilage layer coupled with a bone portion. The cartilage layer comprises a thickness selected to closely match the thickness of existing cartilage at an implant location. The bone portion comprises surface features configured to encourage the patient's bone tissue to grow into the bone portion, thereby accelerating incorporation of the graft into the patient's bone. An instrument kit comprises a multiplicity of instruments configured for implantation of the grafts into the patient's body, including at least a graft inserter, a guidewire, a reamer, and a size gauge.

Abstract: A flexible, cannulated bone implant includes a proximal stem having a proximal end, a distal end, and a proximal conduit extending from the proximal end to the distal end of the proximal stem, a distal stem having a proximal end, a distal end, and a distal conduit extending from the proximal end to the distal end of the distal stem, and a flexible hinge interconnecting the distal end of the proximal stem with the proximal end of the distal stem for allowing the proximal and distal stems to flex relative to one another. The implant includes a proximal stem protective tube disposed within the proximal conduit of the proximal stem, and a distal stem protective tube disposed within the distal conduit of the distal stem. An elongated pin extends through the distal stem protective tube disposed within the distal stem and the proximal stem protective tube disposed within the proximal stem for securing the implant to bone.

Abstract: A tissue fixation device for securing soft tissue to bone includes an expandable outer sheath, and an inner screw in threaded cooperation with the sheath. The expandable sheath comprises opposing walls in hinged engagement. When the screw is inserted into in the sheath, the walls pivot outwardly about a distal hinge to compress a tissue graft against the bone hole, and to lock the device therein. An optional cortical button is secured across the bone hole entrance, and tethered to the fixation device to bolster fixation.

Abstract: The present invention relates to the use of polysulfated polysaccharides in combination with progenitor cells to improve the viability of the progenitor cells including improving the cryopreservation of the progenitor cells and provides novel compositions, methods and uses. The present invention also relates to the use of polysulfated polysaccharides to regulate the proliferation and differentiation of progenitor cells.

Abstract: A method of reinforcing a biological construct according to an exemplary aspect of the present disclosure includes, among other things, attaching a suture loop/needle construct to a reinforcement material and stitching the reinforcement material to a biological construct to form a reinforced biological construct. The reinforcement material is attached to the suture loop/needle construct prior to approximating the reinforcement material to the biological construct.

Abstract: Compositions including a surface or film comprising nanofibers, nanotubes or microwells comprising a bioactive agent for elution to the surrounding tissue upon placement of the composition in a subject are disclosed. The compositions are useful in medical implants and methods of treating a patient in need of an implant, including orthopedic implants, dental implants, cardiovascular implants, neurological implants, neurovascular implants, gastrointestinal implants, muscular implants, and ocular implants.

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: A medical device for implantation in a hip joint of a patient is provided. The medical device comprises a first and second piece and a releasing member adapted to, in a first state hold the first piece attached to the second piece, and in a second state release the first piece from the second piece. The releasing member is adapted to change from the first state to the second state when a pre-determined strain is placed on the releasing member.

Abstract: A bone implant matrix for human or veterinary use, the matrix including a base matrix either treated or to be treated with a reinforcing mixture containing at least a polymer. The bone implant matrix is particularly adapted for use in bone reconstructive surgery, maxillo-facial bone reconstructive surgery and oral surgery.

Abstract: A method of forming a suture tape assembly having a visually distinguishable midpoint includes weaving a longitudinally central portion of a length of round suture material together with other strands of material to form a length of suture tape. This suture tape has a longitudinal first end and a longitudinal second end, and the length of round suture material extends from both the first end and second end. Next, a center part of the length of the round suture material is grasped and pulled outwardly from the suture tape, to form a partial loop extending outwardly from the suture tape. This partial loop is cut from the suture tape, thereby leaving a longitudinally medial segment of the suture tape without the round suture material, and thereby being made visibly distinguishable from neighboring suture tape, which includes the round suture material.

Abstract: The disclosure describes implantable bioprosthesis and constructs having an implantable woven ribbon with at least one integrated suture.

Abstract: An inguinal hernia prosthesis includes a cord locating structure that provides cord protecting functions. The cord locating structure, which may be a semi-circular or other shaped recess positioned along a longitudinal peripheral edge of the prosthesis, is designed to only surround a portion of the cord, e.g. less than 180 or preferably 120 degrees, with the remaining cord circumference being positioned by the element against appropriate muscle tissue. The cord locating structure may be referenced as a non-encircling lateral cord locating structure. The prosthetic: provides tension free repair; minimizes cord damage through tissue ingrowth/strangulation effects, inadvertent suturing through the cord structure, and abrasion with the prosthetic; and minimizes size of prosthetic used in the repair; and is configured to reconstitutes the pre-hernia muscle physiology.

Abstract: Spinal stabilization devices, systems, and methods are described. Foramenal spacers including a rigid member adapted to maintain the integrity of the foramenal space. Facet joint stabilizing members and prosthetic facet joints that augment or replace the native facet joint are also described. Lateral spinal stabilization systems that may be attached to the lateral surfaces of adjacent vertebral bodies are described. Also described are anterior spinal stabilization systems that are to be attached to the anterior surfaces of adjacent vertebral bodies. Several variations of dynamic spinal stabilization devices and systems are described. Each of the foregoing devices, systems, and methods may be used independently, in combination with the other devices, systems, and methods described herein, and/or in combination with prosthetic intervertebral discs.

Abstract: A scaffold for reshaping the cartilaginous portion of an ear. The scaffold is formed of shape memory material and in the form of a horseshoe shape, or is formed from a thermoplastic pliable material.

Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

Abstract: Disclosed are composite implantable tissue attachment devices comprising a mechanical reinforcing component and a cellular scaffold component. Disclosed devices include a wide, relatively flat portion for supporting long term repair of tissue. Disclosed devices can include a tapered portion at the end of the wide portions that can lead into a narrower elongated extension for aiding in placement of the device during a surgical procedure. The wide portion of the device can provide tensile strength along the longitudinal axis of the device as well as porosity. The wide devices can cover a larger surface area of a delivery site than standard suture. Disclosed materials can be utilized in, e.g., soft tissue repair such as tendon and ligament reconstruction and repair.

Abstract: A flat self-curling permeable sheet membrane containing a matrix formed of crosslinked biopolymeric fibers. The matrix self-curls into a predetermined shape upon absorption of an aqueous fluid and is permeable to molecules having molecular weights not greater than 1×106 daltons. Also disclosed is a method of preparing such a flat self-curling permeable membrane.

Abstract: Methods and apparatus provide for coupling an elongate guide substantially at a first end to at least one vertebral body of a spinal column of a patient; and extending a second end of the guide to a structure of the patient spaced in an anterior direction away from the at least one vertebral body towards an entry incision.

Abstract: A fixation device can be delivered to the body of a patient by coupling the fixation device to a delivery instrument at a head of the fixation device. Engaging the fixation device to the delivery instrument at the fixation device's head allows the fixation device to be secured to a tissue and/or ligament of the patient. The fixation device can be a sling for placement around the bladder neck of a female patient.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

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: Methods and devices are provided for fixing a ligament graft in a bone tunnel. In general, the methods and devices involve affixing a ligament graft within a bone tunnel using an adhesive. A fixation device can be inserted through the ligament graft in a direction transverse to an axis of the tunnel to maintain the ligament graft in contact with the adhesive. The fixation device can be removed when the adhesive is cured such that the ligament graft is fixed in the tunnel.

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: Medical delivery devices include a needle and a flexible compressible impermeable tube attached to the needle. The compressible tube has an open interior channel. The device is adapted to releasably hold a length of a medical implant in the open interior channel of the tube. The medical implant can be slidably inserted into the interior channel of the tube and is loosely held by the tube.

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: 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: Disclosed is a cell sheet for tissue repair and bio-artificial tissue engineering. The cell sheet comprises treated stem cell embedded in its self-secreted extracellular matrix (ECM) and formed a cell sheet. The cell sheet is formed by isolating the stem cell, expanding the stem cell and treating the stem cell with biological factors or factors leading to the production of biological factors, to induce its differentiation, production of extracellular matrix and formation of a cell sheet in vitro. The cell sheet is used as a bioactive material or as an acellular material for the promotion of tissue repairs or used to form a bio-artificial organ for tissue replacement. The cell sheet of the present invention eliminates the need to use scaffolds for cell delivery. The cell sheet facilitates in vivo cell transplantation and provides some tensile mechanical strength for bearing early mechanical load during tissue repair.

Abstract: The present invention relates to a novel composition comprising carbon nanotubes and/or graphene and a supporting material that can be used as an implant, patch or construct for the treatment, repair or replacement of biological tissue, including musculoskeletal tissue, fascia tissue, dura tissue, epidermal tissue, blood vessels and arteries, and organs. The present invention is also a method of manufacturing the novel composition, and a method of using the novel composition to treat, repair or replace biological tissue.

Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by arthroscopic means that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

Abstract: Degradable bioprostheses made of collagen-based material having amine-based and ester-based crosslinks are provided, as are methods for their formation and use. Some embodiments of the present invention are directed towards a method of controlling the ratio of amine-based crosslinks to ester-based crosslinks within a collagen-based material to provide a tailorably crosslinked collagen-based material. Some embodiments provide a method of making a degradable bioprosthesis involving controlling crosslinking to afford a degradable bioprosthesis that is partially crosslinked. By controlling the ratio of amine-based to ester-based crosslinks, by controlling the level of crosslinking, or by controlling both of these features, degradable bioprostheses with tailored degradation rates can be synthesized. Some embodiments of degradable bioprostheses have degradation rates that are tailored to allow their use in particular medical applications.

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: The invention relates to an implantable prosthetic device for the repair of connective tissue in an animal or a human. In one embodiment, an implantable prosthetic device (100) for the repair of connective tissue (500) in an animal or human is disclosed which comprises a biocompatible pad (101) having an open structure to provide a scaffold for the in-growth of tissue into the pad; and a reinforcement region (206) attached to or formed integrally with the pad. The device is arranged so that it can be attached to tissue by forming a puncture (301) either a) within the reinforcement region, or b) in an area of the pad which is inboard of the reinforcement region, so that a suture (300) can be located through the puncture, the reinforcement region serving to support tensile loading in the device during use by resisting pull-through of the suture.

Abstract: This document relates to methods and materials involved in tendon or ligament tissue engineering. For example, methods and materials for generating a composite of acellular tendon or ligament allograft slices seeded with cells and bundled into a graft for tissue repair are provided.

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: 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.