Abstract: A myocardial implant for insertion into a heart wall for trans myocardial revascularization (TMR) of the heart wall. The TMR implant provides for means to promote the formation of new blood vessels (angiogenesis), and has a flexible, elongated body that contains a cavity and openings through the flexible, elongated body from the cavity. The TMR implant includes a coaxial anchoring element integrally formed at one end for securing the TMR implant in the heart wall.

Abstract: There is disclosed a method of stent placement which comprises first guiding a guidewire through the vasculature. Second, a balloon catheter which contains two guidewire lumens is strung along the guidewire into position at the bifurcation. The distal opening of the second guidewire lumen abuts the proximal end of the bifurcation. Thereafter, a second guidewire is strung through the first balloon catheter and out the distal opening of the second guidewire lumen. Thus, resident in the second bifurcation leg is the second guidewire. Then, a second standard stent delivery balloon catheter is guided along the second guidewire to a position within the bifurcation. Typically, expansion of both stents can be done one right after the other after proper placement of the first and second balloons.

Abstract: An article (e.g., in the form of an implantable medical article) in the form of a support material bearing an intermediate layer consisting of a functional silicone polymer formulation, the intermediate layer having photoimmobilized thereon a target compound. In another aspect, a method of fabricating an article including the steps of providing a support material, applying an intermediate layer and photoimmobilizing a target compound onto the intermediate layer, and optionally, reforming the support material into a final desired article.

Abstract: The present invention is directed to the assessment of ischemic wound therapeutics by characterizing wound healing parameters such as epithelialization, granulation tissue formation and contraction. The present invention is also directed to an animal model for assessing ischemic wound therapeutics.

Abstract: A filler material for a surgically implantable prosthesis comprised of a synthetic triglyceride having a viscosity substantially greater than that of naturally occurring triglycerides is provided. The triglyceride composition is formed of saturated alkyl chains to reduce or limit the potential for oxidation of the alkyl chains to form peroxide groups which adversely affect the biocompatibility of the filler material and the implant. Preferably, the filler material has a viscosity substantially the equivalent of a normal human breast. The synthetic triglyceride filler material may also have a lower viscosity which is a liquid at room temperature for use in inflatable devices. Prostheses containing filler material having the desired viscosity and antioxidation characteristics are also provided as well as a method for preparing the filler material.

Abstract: The present invention relates to a prosthetic device for placement in an implant area of the body. The prosthetic device comprises an elongated stem portion, a neck portion, and a head portion. Each of the stem, neck, and head portions comprise a material impregnated with an antibiotic agent such that, when the prosthetic device is inserted into the implant area in place of a weight-bearing prosthesis, the antibiotic agent can leach out of the material to fight infection in the implant area. As an added benefit, the structure of the prosthetic device maintains adequate joint spacing in opposition to contraction of the muscles and tendons of the patient over a period of time so that a weight-bearing prosthesis can again be implanted into the implant area after the infection has been overcome.

Abstract: A system for intersomatic fusion and setting of vertebrae. The system includes at least one open internal cage arranged for receiving spongy bone or bone substitute and is designed to be interposed between two vertebrae during diskectomy. The cage (1) includes on its anterior face (5) an external element forming a plate (12) extending in a plane substantially perpendicular to the insertion plane of the cage (1), and has at each of its ends an anchor device (13,14) adapted for anchoring to at least two adjacent vertebrae to be secured to each other by the cage (1). The system can be separated into two parts, the cage and the plate.

Abstract: A device such as a stent is provided with a hybrid coating including a time released, restenosis inhibiting coating and a non-thrombogenic coating to prevent clotting on the device. One first coat or layer includes a polymer, a crosslinking agent, and pacitaxel, analogues, or derivatives thereof. The first coat preferably includes a polymer having Taxol admixed therein so as to be releasable over time. The first coat preferably includes a polyfunctional aziridine as the crosslinking agent. The second coat preferably includes heparin to inhibit clot formation on the device. The crosslinking agent can covalently bond to both the first coat polymer and the second coat heparin. A stent can be provided with a first coat including an aqueous dispersion or emulsion of a polymer and an excess of crosslinking agent. The first coating can be dried, leaving a water insoluble polymer coating.

Abstract: An enhanced visibility composition for implantation from a remote source, so that the composition can be readily observed under fluoroscopy or other imaging techniques. The compositions include a biocompatible matrix, such as a hard tissue implant material for example, and radiopaque particles mixed in the matrix. The radiopaque particles have a particle size between about 120&mgr; and 2200&mgr;, more preferably about 350&mgr; and 2200&mgr;, even more preferably between about 450&mgr; and 1600&mgr;, and most preferably between about 570&mgr;0 and 1150&mgr;. Preferably the hard tissue implant and the radiopaque particles are formed or prepared in a slurry. Optionally, the enhanced visibility composition may further include additional radiopaque particles or contrast particles mixed in with the composition, which have a particle size between about 120&mgr; and 350&mgr;, preferably between about 120&mgr; and 250&mgr;.

Abstract: Disclosed are methods for soft tissue augmentation in a mammal wherein a composition comprising a biocompatible polymer having a water equilibrium content of less than about 15% and a biocompatible solvent is delivered to the tissue of the mammal to be augmented.

Abstract: The present invention relate to a poly(vinyl alcohol) hydrogel construct having a wide range of mechanical strengths for use as a human tissue replacement. The hydrogel construct may include a tissue scaffolding, a low bearing surface within a joint, or any other structure which is suitable for supporting the growth of tissue.

Abstract: The invention creates a thin tubular multiple filament (film or fiber) structure that can hold high internal pressures. When desired, an extension of the filaments can be pulled in any direction to unfurl the structure. This device is useful for self expanding stent or stent graft delivery systems, balloon dilatation catheters, removable guide wire lumens for catheters, drug infusion or suction catheters, guide wire bundling casings, removable filters, removable wire insulation, removable packaging and other applications.

Abstract: A synovial prosthetic member includes a body having an articulating surface and an anchor surface, the articulating surface being configured for articulation with another articulating surface of a synovial joint, the anchor surface being configured for cementing to bone, the body being composed of ultrahigh molecular weight polyethylene (UHMWPE), the anchor surface having been subjected to treatment by either ion implantation, ion beam assisted deposition, or sputter deposition.

Abstract: A method for fixation of biological tissues, and bioprosthetic devices prepared by such method. The method generally comprises the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to terminal sterilization.

Abstract: A bone substitute material is prepared by firing and pulverizing animal bones into animal bone powder, mixing the animal bone powder and a divalent metal compound into a powdery mixture, and kneading the powdery mixture with chitosan sol. Alternatively, a bone substitute sheet is prepared by mixing at least one of apatite and animal bone powder with chitosan sol into a mixture, forming a pre-processed sheet of the mixture, and neutralizing the sheet by an aqueous solution of a compound. The bone substitute material and sheet have a pH value falling within a neutral range.

Abstract: A stent is made generally tubular and is initially formed in a collapsed configuration. A fabric cover is provided for the inner stent and is attached outside the stent at one or more desired locations. The fabric cover is larger in diameter than the diameter of the collapsed stent, however, when the stent is expanded through activation of the balloon catheter therewithin, the stent expands to closely conform to the interior walls of the fabric cover. The securement of the fabric cover or intermediate stent layer about the inner stent is accomplished through the use of a wire spiraling externally about the outer surface of the fabric cover to secure the fabric cover or intermediate stent layer about the inner stent. When the stent sandwich is expanded, the configuration of this spiraling wire permits it to expand as well and lie against the inner walls of the blood vessel at the desired location. The stent has spaced ends, each of which may be coated or otherwise provided with a radio-opaque material.

Abstract: The invention provides a substantially non-immunogenic ligament or tendon xenograft for implantation into humans. The invention further provides a method for preparing a ligament xenograft by removing at least a portion of a ligament from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft cellular disruption treatment, such as exposure to ultraviolet radiation, immersion in alcohol, ozonation, freeze/thaw cycling, and optionally chemical crosslinking. In addition to or in lieu of the above treatments, the methods include digestion of the carbohydrate moieties of the xenograft with a glycosidase, preferably in a range of about 1 mU/ml to about 1000 U/ml, followed by treatment for sialylation. The invention also provides articles of manufacture produced by one or more of the above-identified methods of the invention.

Abstract: Herein are disclosed devices, particularly medical devices, more particularly implantable medical devices, comprising a first layer of a metal and a short chain silicone terminating with silicon hydride, and a second layer of a silicone polymer. The short chain silicone is bound to the metal, and the silicone polymer is covalently bound via the vinyl group to the silicon hydride group of the short chain silicone. Also disclosed herein is a method for making such devices, involving providing the metal, depositing the short chain silicone, molding the silicone polymer as a silicone prepolymer, and polymerizing the silicone prepolymer to yield silicone polymer covalently bonded to the short chain silicone.

Abstract: An implantable prosthesis includes a porous polymeric member having pores present in its wall structure wherein these pores contain a variety of therapeutically useful compositions including, collagen, genetically altered cells and piezoelectric materials. A process of preparing such a prosthesis is also disclosed.

Abstract: Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient's existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient's existing tubular body organ structure. This avoids the need for any significant surgery on the patient. The artificial grafts may have shapes other than tubular. Certain procedural and apparatus aspects of the invention have uses other than in connection with grafting in general or tubular grafting in particular.