Abstract: Medical devices, such as stents, having a surface, a coating layer comprising a polymer disposed on at least a portion of the surface, and a composition comprising a biologically active material injected into or under the coating layer at one or more locations in the coating layer to form at least one pocket containing a biologically active material are disclosed. The composition may be injected using a nanometer- or micrometer-sized needle. Methods for making such medical devices are also disclosed. Using this method, a precise amount of the biologically active material may be disposed accurately and efficiently on the medical device at predefined locations.

Abstract: According to an aspect of the present invention, bioactive polymers are provided which have (a) a hydrophilic bioactive portion and (b) at least one hydrophobic polymer group that is linked to the hydrophilic bioactive portion by a covalent linkage that contains a chain transfer agent residue. According to another aspect of the present invention, medical articles are provided with bioactive surface by coating them with a coating material that contains such bioactive polymers.

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: According to an aspect of the present invention, implantable or insertable medical devices are provided which contain (a) one or more depressions that contain at least one therapeutic agent, and (b) a nanoporous coating, disposed over the therapeutic-agent-containing depressions, which regulate transport of species between the therapeutic-agent-containing depressions and the exterior of the device. The implantable or insertable devices are configured to preform a role beyond mere drug delivery, for example, providing mechanical and/or electrical functions within the body, among other functions. An advantage of the present invention is that medical devices may be provided, which release therapeutic agents in quantities far exceeding the void volume within the nanoporous coating, while at the same time providing functionality that extends beyond drug delivery. Such release may further approach or achieve a zero order kinetic drug release profile.

Abstract: According to an aspect of the present invention, medical articles are provided which comprise the following (a) a polymeric region having a first charge, and (b) a charged therapeutic agent having a second charge that is opposite in sign to that of the first charge. In certain beneficial embodiments, the medical articles are high surface area articles, for example, articles formed using small diameter (e.g., 10 microns or less) fibers.

Abstract: The present invention is directed to the formation of structures in situ through the principles of ligand binding. These structures are efficacious, for example, for tissue repair as well as for short- and long-term disease and condition management. According to one aspect of the invention, an injectable composition comprising self-assembling nanoparticles is provided. The self-assembling nanoparticles include: (a) a nanoparticle portion, (b) tissue binding ligands attached to the nanoparticle portion, which cause preferential binding and accumulation of the nanoparticles at one or more targeted tissue locations upon injection of the composition into the body, and (c) first and second interparticle binding ligands attached to the nanoparticle portion, which cause interparticle binding upon injection of the composition into the body.

Abstract: The present invention relates to a system and method for the delivery of therapeutic agents, such as therapeutic drugs or genetic material, into the muscle or tissue that minimizes the loss of therapeutic agents due to contraction of the muscle. In one embodiment, an implant for delivering therapeutic agents into a muscle is provided, wherein the implant has at least one rod for insertion and delivery of therapeutic agents into the muscle and a patch that can be attached to the exterior surface of the muscle for preventing or minimizing therapeutic agent being expelled due to the contraction of the muscle, such as the beating of a heart muscle.

Abstract: According to an aspect of the present invention, implantable or insertable medical devices are provided, which contain polymeric release regions that control the release of one or more therapeutic agents. The polymeric release regions, in turn, contain one or more polymers that contain one or more rigid, nonplanar polycyclic molecular structures. The therapeutic agent is disposed beneath or within the polymeric release region.

Abstract: The present invention relates to phase separated polymeric regions and to their use in conjunction with implantable or insertable medical devices. In some aspects of the invention, phase separated polymeric regions are provided that include (a) at least one biostable polymeric phase and (b) at least one biodisintegrable polymeric phase, which is of nanoscale dimensions and which undergoes biodisintegration such that the phase separated polymeric region becomes a nanoporous polymeric region in vivo. Other aspects of the invention are directed to methods of making implantable or insertable medical devices having at least one nanoporous polymeric region. These methods include (a) providing a phase separated polymeric region comprising a stable polymeric phase and a disintegrable polymeric phase of nanoscale dimensions, (b) selectively removing the disintegrable polymeric phase thereby producing the nanoporous polymeric region.

Abstract: An implantable or insertable medical device is provided that contains at least one polymeric region which comes into contact with a subject upon implantation or insertion of the device into the subject. The polymeric region(s) contain at least one bulk polymer moiety and at least one surface-active polymer moiety that (a) is covalently attached to the bulk polymer moiety/moieties or admixed with the bulk polymer moiety/moieties and (b) is provided in an amount that is effective in providing the polymeric region(s) with a critical surface energy that is between 20 dynes/cm and 30 dynes/cm upon implantation or insertion of the device into the subject.

Abstract: Methods and apparatuses for coating surfaces of medical devices by electroplating are disclosed. In one embodiment, the invention includes a coating method in which a mixture of a therapeutic agent, and a plating material are electroplated onto the surface of the medical device. The electroplating method may be performed at a relatively low temperature to avoid destruction of the therapeutic agent. In another embodiment, a coating method is disclosed in which the coating is formed by suspending a therapeutic agent in an electrolytic solution and electroplating a plating material onto the medical device wherein the plating material carries the suspended therapeutic agent. Thus, the coating of plating material contains the suspended therapeutic agent. These methods and apparatuses are used to apply one or more coating materials, simultaneously or in sequence by varying the electroplating voltage. In certain embodiments of the invention, the coating materials include therapeutic agents and cationic drugs.

Abstract: According to certain aspects of the invention, implantable or insertable medical devices are provided that contain one or more nanoporous regions, which may further comprise interconnected nanopores. Other aspects of the invention are directed to implantable or insertable medical devices that contain one or more nanostructured regions, which are formed by a variety of methods. Still other aspects of the invention are directed to implantable or insertable medical devices having nanotextured surface regions, in which cell-adhesion-promoting biomolecules (e.g., glycosaminoglycans, proteoglycans, cell adhesion peptides, and adhesive proteins) are provided on, within or beneath the nanotextured surface regions.

Abstract: The present invention is directed to a method in which a supercritical fluid that comprises a carrier fluid and a biologically active agent is brought into contact with medical article that comprises a nanoporous surface region. A variety of medical articles may be used in the practice of the present invention, including implantable or insertable medical devices such as bone plates, joint prostheses, vascular grafts, stent grafts, stents, catheters, guide wires, balloons, filters, vascular patches, shunts, and coils, among others. The nanoporous surface region may be, for example, metallic, ceramic, or polymeric in nature. Examples of biologically active agents include antirestenotic agents and agents that promote tissue adhesion, among others. Carbon dioxide is one of many carrier fluids that may be employed.

Abstract: The present invention is directed to medical devices which comprise the following: (a) an underlying region that comprises a therapeutic agent and (b) a vapor deposited nanoporous coating (e.g., a polymeric, ceramic or metallic nanoporous coating) over the underlying region, which regulates the release of the therapeutic agent from the medical device when it is placed into a subject.

Abstract: The present invention is directed to an expandable stent for implantation in a patient comprising a tubular metal body having open ends and a sidewall structure having openings therein and a coating disposed on a surface of said sidewall structure, said coating comprising a hydrophobic biostable elastomeric material and a biologically active material, wherein said coating continuously conforms to said structure in a manner that preserves said openings.

Abstract: The present invention is directed to an expandable stent for implantation in a patient comprising a tubular metal body having open ends and a sidewall structure having openings therein and a coating disposed on a surface of said sidewall structure, said coating comprising a hydrophobic biostable elastomeric material and a biologically active material, wherein said coating continuously conforms to said structure in a manner that preserves said openings.

Abstract: A medical device for implantation into a host organism is disclosed. The device comprises a surface adapted for contact with body tissue of the host organism and an electrode disposed on at least a portion of the surface. Also the device comprises a power source in direct or indirect electrical communication with the electrode. The power source is capable of providing a current to the electrode to create an average surface charge density on the surface that is effective to promote the biocompatibility of the surface with the body tissue or create other desired biological effects.

Abstract: Medical devices, such as stents, having a surface, a coating layer comprising a polymer disposed on at least a portion of the surface, and a composition comprising a biologically active material injected into or under the coating layer at one or more locations in the coating layer to form at least one pocket containing a biologically active material are disclosed. The composition may be injected using a nanometer- or micrometer-sized needle. Methods for making such medical devices are also disclosed. Using this method, a precise amount of the biologically active material may be disposed accurately and efficiently on the medical device at predefined locations.

Abstract: Medical devices incorporate therein imaging materials having selected MRI detectable nuclei to provide useful magnetic resonance images of the medical devices and proximate body tissue. Also, a method generates MRI images of such a medical device, and involves performing first and second MRI processes on a body portion including at least a portion of the medical device to obtain, respectively, first and second image data. The first MRI process is adapted to detect MRI detectable nuclei present in the proximate body tissue, and the second MRI process is adapted to detect the selected MRI detectable nuclei contained in the device's imaging material. The selected MRI detectable nuclei incorporated in the imaging material is not the same nuclei that the first MRI process is adapted to detect. The second image data are combined with the first image data to produce image data for the medical device and the proximate body tissue.

Abstract: Implantable or insertable medical devices comprising a surface region that is modified by covalently coupling a molecular species (or a combination of molecular species) to the same. The molecular species are selected such that the resulting modified surface region has critical surface energy between 20 and 30 dynes/cm. In certain embodiments, the covalently coupled molecular species comprise one or more methyl groups. An advantage of the present invention is that novel medical devices are provided, which have a surface with a critical surface energy value that has been shown to display enhanced biocompatibility, including enhanced throboresistance, relative to other surfaces.