Abstract: A medical device (1) of a biocompatible material for use in the treatment of a gap or defect in the central nervous system, which device has a proximal end (5) and a distal end (6) comprising openings (7). The device is adapted to enable connection of nerve fibers of gray and white matter between the proximal end (5) and distal end (6) thereof in predetermined openings (7). The device is of a substantially cylindrical form, or a substantially flat or plate like form and is made of plastic. The openings (7) in at least one end (5, 6) bear distinctively different indicia thereby to indicate whether nerve fibers of gray matter or nerve fibers of white matter are to be inserted therein.

Abstract: A guidance channel or conduit for promoting nerve regeneration includes a body constructed of a biocompatible polymeric material and having a first end for connection to a proximal stump of a severed nerve and a second end for connection to a distal stump of the severed nerve. The body includes a plurality of internal lumens extending between the first and second end to facilitate rejoining of the proximal and distal stumps of the severed nerve by providing increased surface area for Schwann cell adherence. A method for promoting nerve regeneration using a multi-lumen nerve guidance channel is also disclosed.

Abstract: The invention concerns a connecting device for anastomosis of a vascular prosthesis to a tubular conduit in which a lateral or terminal opening has been formed, the prosthesis including, at a connecting end, a turned-back portion forming an annular layer whose free edge is adapted to be pressed onto the immediate vicinity of the rim of the tubular conduit. The connecting device includes a set of fasteners each of which is adapted to press the annular layer onto the rim of the opening. It further includes an annular support along which the fasteners are distributed. The fitting device includes a connecting device and a releasable holding mechanism for holding the fasteners in the open position. The implant comprises a vascular prosthesis and a fitting device.

Abstract: A bioartificial extracellular matrix for use in tissue regeneration or replacement is provided by derivatizing a three-dimensional hydrogel matrix with a cell adhesive extracellular matrix protein or cell adhesive peptide fragment of the protein. Preferably, derivatizing is by covalent immobilization of a cell adhesive peptide fragment having the amino acid sequence, ArgGlyAsp, TyrIleGlySerArg or IleLysValAlaVal. Cartilage or tendon can be regenerated by implanting a matrix containing an adhesive peptide fragment that favors chondrocyte invasion. The matrix can be pre-seeded with cells, and tissue can be reconstituted in vitro and then implanted. A cell-seeded matrix can be encapsulated in a semi-permeable membrane to form a bioartificial organ. An agarose hydrogel matrix having an agarose concentration of 0.5-1.25% (w/v) and an average pore radius between 120 nm and 290 nm is preferred.

Abstract: A neuro decompression device is disclosed that significantly reduces fibroplasia proximate to nerve tissue. The device utilizes particular surface topographies to disrupt scar tissue formation around nerves, and which may include one or more drugs to influence tissue growth.

Abstract: A medical anastomosis sling for use in the repair or regeneration of nerves. Nerve ends are placed in a breathable semiporous membrane having sets of elongate and wide tabs which are secured and sealed around the ends via circumferential fasteners and surgical clips for securing and sealing the sling in position without the necessity of suturing the device for optimal anastomosis.

Abstract: The present invention offers an artificial tube for nerve which can remain in the body until the nerve regenerates while does not remain as a foreign body in the body following nerve regeneration, and which induces axons regenerated from severed nerve stumps, can promote infiltration of blood capillaries from the body and regeneration of nerve tissue. The present invention comprises a tube 10 or 20 having coating layers 12, 13 or 22, 23 composed of gelatin or collagen on the inner and outer surfaces of a tube 11 or 21 composed of a material being biodegradable and absorbable in vivo, and a collagen body 30 or 40 having cavities 32, 33 or 41 which pass through said tube so as to be substantially parallel to the axis of said tube; wherein, said cavities are filled with a matrix gel.

Abstract: An implantable bioabsorbable article for the separation and regeneration of tissue at a tissue defect site in the form of a fibrous matrix laminarly affixed to both surfaces of a cell-barrier sheet material. When implanted it allows ingrowth of tissue into the fibrous matrix side of the material; simultaneously the tissue to be regenerated at the tissue defect site is separated from the ingrowing tissue by the cell-barrier sheet material. A method for making the implantable bioabsorbable article is also described.

Abstract: An implantable bioresorbable membrane for the separation and regeneration of tissue in a defect site and augmentation of tissues surrounding other implants comprises: (a) porous bioresorbable polymer matrix made of a bioresorbable polymer selected from the group consisting of polylactic acid, poly(lactic-co-glycolic acid), polycarprolactone, polyparadioxanone, polytrimethylene carbonate and a mixture thereof; and (b) a reinforcing fabric made of bioresorbable fibers embedded in said matrix, and is produced by preparing a fabric as a support from bioresorbable fibrous materials, coating the fabric with a solution containing a bioresorbable polymer and a pore forming agent, and treating the coated fabric to generate pores.

Abstract: A guidance channel or conduit for promoting nerve regeneration includes a body constructed of a biocompatible polymeric material and having a first end for connection to a proximal stump of a severed nerve and a second end for connection to a distal stump of the severed nerve. The body includes a plurality of internal lumens extending between the first and second end to facilitate rejoining of the proximal and distal stumps of the severed nerve by providing increased surface area for Schwann cell adherence. A method for promoting nerve regeneration using a multi-lumen nerve guidance channel is also disclosed.

Abstract: A tendon repair clip implant system for placement on the dorsal side of a cerated or torn tendon to allow active range of motion post tendon repair, comprises: first and second clips. Each clip comprises:(i) two serrated sections joined by integral connecting section; the serrated sections being urgeable together to provide opposing mating teeth connection by arculate bending longitudinally around an axis of the connecting section;ii) the repair clip further comprising two relatively flat surfaces adjoining the connecting section and having openings therein through which sutures may be threaded and drawn through a lacerated tendon to assist in holding said tendon together; the openings being centered between a plurality of spikes extending from undersides of the flat surfaces to function as tendon inserts to assist in holding the lacerated tendon together.

Abstract: The present invention is drawn to medical devices comprising biodegradable guide channels for use in the repair and regeneration of nerve tissue. The guide channels of the present invention comprise interlaced threads imbedded in a matrix, wherein both the matrix and the threads comprise biocompatible and bioabsorbable esters of hyaluronic acid. The matrix of the present invention further optionally comprises biologically or pharmacologically active factors in association with the guide channels.

Abstract: A bioartificial three-dimensional hydrogel extracellular matrix derivatized with a cell adhesive peptide fragment is provided for use in tissue regeneration or replacement. The choice of adhesive peptide fragment depends on the desired target cell type. Cartilage or tendon can be regenerated by implanting a matrix containing adhesive peptide fragments that favor chondrocyte invasion. The matrix can be pre-seeded with cells, and tissue can be reconstituted in vitro and then implanted. A cell-seeded matrix can be encapsulated in a semi-permeable membrane to form a bioartificial organ. An agarose hydrogel matrix having an agarose concentration of 0.5-1.25% (w/v) and an average gel pore radius between 120 nm and 290 nm is preferred. The peptide fragment preferably contains the sequence, ArgGlyAsp or TyrIleGlySerArg or IleLysValAlaVal, and is covalently immobilized to the matrix.

Abstract: The invention concerns a complex comprising a cell adhesion protein or a fragment thereof and Cu ions. The cell adhesion protein may be, for example, fibronectin and the Cu ions may be, for example, Cu.sup.2+ ions. The Cu ions stabilize the cell adhesion protein and the complex may be used to promote wound healing.

Abstract: Methods and devices are disclosed for inducing growth of neural cells, and repairing neural defects in a mammal. The method comprises administering to said mammal at the site of neural defect, damage or depletion, an effective amount of a bone morphogenetic protein, either in admixture with a pharmaceutically acceptable vehicle, or adsorbed to a suitable matrix. The device comprises bone morphogenetic protein, optionally in combination with other factors, adsorbed on a suitable matrix and contained within an artificial nerve replacement vessel.

Abstract: The present invention is drawn to medical devices comprised of biodegradable guide channels for use in repair and regeneration of nerve tissue. The guide channels are comprised of threads embedded in a matrix and coextruded with active factors wherein both the matrix and the threads are comprised of biocompatible and bioabsorbable esters of hyaluronic acid.

Abstract: An implantable prosthesis and device and method for loading and delivering the implantable prosthesis to a trocar cannula. The implantable prosthesis includes a body portion sufficient to extend across and occlude a defect opening and a semi-rigid ring for supporting the body portion. The implantable prosthesis may be provided with a sufficient hoop strength to prevent the body portion from collapsing into the defect opening. A loading and delivery tool includes a main body with a lumen sized to collapse the implantable prosthesis. An elongated shaft is rotatable to wind the implant into a slender configuration and axially moveable to advance the rolled-up implant into the trocar cannula. A cartridge extends from the main body and holds the implant in a normal expanded configuration.

Abstract: The present invention provides an anti-N-CAM monoclonal antibody which enhances, rather than inhibits, neurite outgrowth both in vitro and in vivo. The antibody has positive regulatory effects on nerve cells of both the central and peripheral nervous systems, and is useful for enhancing neurite outgrowth in in vitro studies and for improving nerve regeneration and repair in vivo.

Abstract: The invention relates generally to a system for promoting regeneration of a damaged nerve. In particular, the invention comprises: (1) a guide tube constructed to be attached to the damaged nerve; (2) guiding filaments disposed within the guide tube; and, (3) a therapeutic composition enclosed by the guide tube. Both the guide tube and the guiding filaments are composed of biologically compatible materials, while the therapeutic composition contains a nerve-growth-stimulating agent dispersed in a matrix-forming material. During treatment, the guide tube is inserted between the ends of lesioned nerves, resulting in the stimulation of axon growth.

Abstract: The present invention provides an anti-N-CAM monoclonal antibody which enhances, rather than inhibits, neurite outgrowth both in vitro and in vivo. The antibody has positive regulatory effects on nerve cells of both the central and peripheral nervous systems, and is useful for enhancing neurite outgrowth in in vitro studies and for improving nerve regeneration and repair in vivo.

Abstract: The present invention provides an anti-N-CAM monoclonal antibody which enhances, rather than inhibits, neurite outgrowth both in vitro and in vivo. The antibody has positive regulatory effects on nerve cells of both the central and peripheral nervous systems, and is useful for enhancing neurite outgrowth in m vitro studies and for improving nerve regeneration and repair in vivo.

Abstract: A regeneration chamber for promoting and controlling the growth of biological nerves, including a chamber enclosing and defining a volume in which biological nerves are to be grown, an input port for injecting agents for promoting and controlling the growth of the biological nerves into the chamber, and an output port for receiving agents and biological nerve growth byproducts from the chamber. The input port and chamber have at least one input passage therebetween for the flow of agents from the input port into the chamber and the output port and chamber have at least one output passage therebetween for the flow of agents and biological growth byproducts from the chamber into the output port. The input and output passages are proportioned to reduce increases and decreases in pressure in the chamber and a chamber may have a plurality of input ports and output ports.

Abstract: A piezoelectric medical device prepared by electrostatically spinning a copolymer of vinylidene fluoride and a second fluorinated hydrocarbon, and collecting the spun fibers on a suitable receiver. The medical device can be in the form of a vascular prosthesis, neural prosthesis, or wound dressing and the copolymer can be composed of a predominant amount of vinylidene fluoride.

Abstract: A device for preventing adhesions or binding of tissue to tissue or of tissue to bone which comprises a composite of a first layer and a second layer, each of which comprises a biodegradable polymer, such as, for example, a polyethylene glycol/polybutylene terephthalate copolymer. The first layer is selected from the group consisting of a non-porous layer and a porous layer having a pore size no greater than 3.mu.. The second layer has pores which have a pore size of from about 30.mu. to about 250.mu.. The device is placed between two tissues or between tissue and bone. Such a composite device provides for tissue growth into the second layer, while the first layer acts as an adhesion-preventing barrier, and enables attachment of the device to tissue without suturing. Alternatively, the device comprises the first layer hereinabove mentioned and a second layer which is an adherence layer and which adheres to tissue and/or bone.

Abstract: Disposable approximator for approaching nerve-endings particularly to facilitate sewing and replacement of injured nerves. The disposable approximator according to the invention comprises surgical metal hooks (3) known in the artwork. The approximator has a sliding leg (1) made of a synthetic material suitable for sanitary and surgical purposes. One surface thereof is designed with a structural formation allowing unidirectional displacement. At the end of the sliding leg (1) lying in direction of motion a fixed carrier-console (2) is arranged, into which one or more surgical metal hooks (3) are built-in that their ends are facing the direction of motion. Onto the sliding leg (1) a slide (4) is arranged, movable towards the fixed carrier-console (2), with a clearance enabling displacement. One or more surgical hooks (3) are built-in into the slide (4) so that their ends are facing the fixed carrier-console (2).

Abstract: Nerve channels made from high molecular weight lactic acid polymers, preferably polymers having a molecular weight between about 234,000 and 320,000, provide an unexpectedly beneficial effect on cell growth and regeneration of function.

Abstract: A nerve repair device includes a resilient, elongated implant, and transverse pins for retaining the implant fixedly within the ends of the severed nerve. A sharp tip extends longitudinally from at least one end of the elongated implant, and aids in the insertion of the implant longitudinally through the ends of the severed nerve between the fascicle bundles. The severed ends are retained in close approximation for reconnection.

Abstract: A windlass is mounted in fixed position external to the body and close to the nerve tissue to be lengthened. A first path in the form of a hollow member is made between the windlass and a second path, along which the nerve tissue is to be extended. A line is connected to the rotatable drum of the windlass and is passed along the first path and the second path to the nerve tissue. The line is connected by a protective cap to the nerve tissue. The drum is rotated, winding the line about the drum and drawing the line through the first and second paths while drawing the nerve tissue along the second path.

Abstract: A method of using a bioabsorbable tube device for the repair of nerve defects or gaps comprising the steps of selecting a flexible, porous, bioabsorbable tube device and, then, suturing the nerve ends within the tube device such that a predetermined gap is left between the proximal and distal nerve ends to allow for nerve axon growth across the nerve gap from the proximal nerve end to the distal nerve end.

Abstract: A method and apparatus for reconnecting stumps of transected cable-like organs, such as nerves, is disclosed. The apparatus comprises a template and a connector. The connector has inscribed guide lines that indicate proper placement of the nerve stumps for optimum healing. The nerve stumps are connected to the connector, trimmed and the template is removed.

Abstract: A medical device is disclosed for use in regenerating a severed nerve, including a tubular, biocompatible, electrically-charged membrane or guidance channel, having openings adapted to receive the ends of the severed nerve and defining a lumen through which the nerve can regenerate. The electrically-charged membrane can further include a polymeric electret material that is electrically poled. A method for repairing a severed nerve is also disclosed and includes placing severed nerve ends in proximity to each other within the lumen of the guidance channel of the present invention and securing the nerve ends to the device.

Abstract: This invention relates to an implantable medical device capable of encouraging cellular growth and regeneration of function fabricated totally or in part from one or more bioresorbable polymers, as for example bioresorbable homopolymers derived from the polymerization of alpha-hydroxy carboxylic acids, where at least one of the polymers has an average molecular weight of from about 234,000 to about 320,000 as measured by gel permeation chromatography.

Abstract: A medical device is disclosed for use in regenerating a severed nerve. The device includes an implantable, tubular, electrically-charged membrane having openings adapted to receive the ends of the severed nerve and a lumen having a diameter ranging from about 0.5 millimeters to about 2.0 centimeters to permit regeneration of the nerve therethrough. The membrane is fabricated such that an electric charge is exhibited at the inner membrane surface to stimulate regeneration by axonal sprouting and process extension. Also disclosed are methods for repairing a severed nerve and for preparing a medical device for use in regeneration of a severed nerve.

Abstract: The present invention is directed to hollow conduits whose walls are comprised of Type I collagen and are characterized by having a multi-layered, semi-permeable structure, which conduits are used to promote nerve regeneration across a gap of a severed nerve. Methods of making the nerve regeneration conduit are also disclosed.

Abstract: The present invention is directed to a hollow conduit comprised of a matrix of Type I collagen and laminin-containing material which conduit is used to promote nerve regeneration across a gap of a severed nerve. Methods of making the nerve regeneration conduit are also disclosed.

Abstract: Medical devices and methods employing biocompatible polymers and nerve growth-enhancing active factors are disclosed for use as guidance channels for regenerating nerves. The devices are formed from a porous, tubular membrane containing active factor incorporated within the membrane and having openings adapted to receive the ends of the severed nerve. In one aspect of the invention, the membrane has an impermeable, outer membrane surface and a porous, inner membrane surface through which the active factor can diffuse and which defines the boundary of a lumen through which said nerve may regenerate. Methods for fabricating such devices are also disclosed.

Abstract: A method and apparatus for reconnecting stumps of transected cable-like organs, such as nerves, is disclosed. The apparatus comprises a template and a connector. The connector has inscribed guide lines that indicate proper placement of the nerve stumps for optimum healing. The nerve stumps are connected to the connector, trimmed and the template is removed.

Abstract: The present invention is directed to hollow conduits whose walls are comprised of Type I collagen and are characterized by having a multi-layered, semi-permeable structure, which conduits are used to promote nerve regeneration across a gap of a severed nerve. Methods of making the nerve regeneration conduit are also disclosed.

Abstract: The neural cell adhesion molecule is used in nerve prostheses for the repair of peripheral nerve damage in mammals, both animal and man. In particular, in a process wherein a crushed or severed nerve ending is entubulated by use of a prosthetic device, a neural cell adhesion protein is added to the prosthetic device to increase the rate of growth of the fibrous components of the nerve, to more rapidly regenerate the nerve, and provide a more complete restitution of the function of the muscle served by the regenerated nerve.

Abstract: A method for producing a biodegradable polymer having a preferentially oriented pore structure and a method for using the polymer to regenerate damaged nerve tissue is disclosed. The preferentially oriented pores are produced by an axial freezing process and serve to promote proper vascularation and regeneration of the damaged nerve. Preferably, the biodegradable polymer comprises uncrosslinked collagen-glycosaminoglycan.

Abstract: Disclosed is a splint-like element for use in end-to-end nerve suture to eliminate tension at the anastomosis site and thus allow optimal coaptation between the nerve ends to be sutured. The element comprises an elongated body made of a material that is rigid and slightly resilient and is biologically acceptable, such as silicone. The body is long enough to have one end attachable to the epineurium of one of the nerve ends by at least one but preferably two longitudinally spaced-apart sutures, and another end attachable to the epineurium of the other nerve end also by at least one but preferably two other longitudinally spaced-apart sutures. The element also comprises pieces of reinforcing material preferably consisting of beads of plastic material embedded into the body material wherever this body is intended to be attached to the epineurium to prevent the body material from being torn or otherwise cut by the sutures.