Abstract: A biocompatible implantable bone anchor is provided that has a threaded first portion that engages and anchors into a bone. The implant also has a neck region extending from the first portion adapted to promote autologous cell growth thereon at an interface of the bone and one or more epidermal or gum layers, the neck region having a plurality of channels extending about the neck region. The neck region is configured to mechanically engage at least one of an abutment, dental restoration, or osseous device attachment. An in situ bone anchor cell growth assembly includes the bone anchor and a manifold encompassing the neck portion so as to form a seal therebetween and a route of fluid communication between a manifold inlet and at least one of said plurality of channels. A process for growing autologous cells on a neck region of a bone anchor is provided.

Abstract: A hemostatic insert is provided for closing a puncture site in a blood vessel wall. The insert includes an expandable hemostatic member comprising a biocompatible water soluble gel configured to expand from a compressed state when exposed to body fluid and seal the puncture site in the blood vessel wall. A control layer surrounds the hemostatic member and delays expansion of the hemostatic member.

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: A biocompatible implantable bone anchor is provided that has a threaded first portion that engages and anchors into a bone. The implant also has a neck region extending from the first portion adapted to promote autologous cell growth thereon at an interface of the bone and one or more epidermal or gum layers, the neck region having a plurality of channels extending about the neck region. The neck region is configured to mechanically engage at least one of an abutment, dental restoration, or osseous device attachment. An in situ bone anchor cell growth assembly includes the bone anchor and a manifold encompassing the neck portion so as to form a seal therebetween and a route of fluid communication between a manifold inlet and at least one of said plurality of channels. A process for growing autologous cells on a neck region of a bone anchor is provided.

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: A method of treating a biological tissue including crosslinking with glutaraldehyde; immersing the biological tissue in a first solution containing glutaraldehyde and heat in the first solution to a temperature of about 50° C. for a first period of time; immersing the biological tissue in a second solution containing a mixture of a crosslinking agent, a denaturing agent and a surfactant; and immersing the biological tissue in a sterilizing solution containing glutaraldehyde and heating the sterilizing solution to a temperature of 37.5±2.5° C. for a sterilizing period of time. The method may include a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include 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.

Abstract: Described herein are implantable medical devices comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue. The triggerable bioadhesive property of the polymer can be triggered or activated by exposure to a stimulus. Also, the present invention pertains to methods of making an implantable medical device comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue.

Abstract: According to an aspect of the present invention, medical devices are provided, which contain (a) a substrate and (b) a polymeric region disposed over the substrate which contains at least one block copolymer. The block copolymer, in turn, contains at least two polymer blocks which phase separate into two or more immiscible phase domains within the polymeric region. Moreover, a bioactive species is covalently attached to at least one of the polymer blocks. By attaching the bioactive species selectively to at least one polymer block, self-assembled clusters of the bioactive species are created as the blocks phase separate into immiscible phase domains.

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: 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 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: 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: 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 thromboresistance, relative to other surfaces.

Abstract: The present invention relates to novel biomaterials and methods of using these new biomaterials to facilitate wound healing. The novel biomaterial may be a biocompatible polymer to which at least one bioactive polymer is covalently bonded by graft polymerization, copolymerization or cross-linking. Alternatively, the novel biomaterial may be a polymer blend comprising at least one biocompatible polymer and at least one bioactive polymer.

Abstract: According to an aspect of the invention, implantable or insertable medical devices are provided which contain the following: (a) one or more porous regions comprising pores and (b) one or more therapeutic agents which are (i) contained within the porous region, (ii) disposed beneath the porous region, or (iii) both. Moreover, the porous regions are capable of undergoing a change in configuration, such that the pores undergo a change in configuration, upon subjecting the porous regions to activating stimuli.

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: Described herein are implantable medical devices comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue. The triggerable bioadhesive property of the polymer can be triggered or activated by exposure to a stimulus. Also, the present invention pertains to methods of making an implantable medical device comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue.

Abstract: Embolic particles, embolic particle chains, and methods for making embolic particles and embolic particle chains are described.

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: According to an aspect of the present invention, long term medical articles are provided which include the following: (a) first and second body contacting (e.g., tissue and/or body-fluid contacting) porous polymeric layers; (b) a polymeric barrier layer disposed between the first and second porous polymer layers; and (c) a reinforcement element. According to another aspect of the present invention, tubular medical articles for long term implantation are provided, which comprise: (a) a reinforcement element; (b) a blood contacting porous polymeric layer having a surface energy ranging between 20 and 30 dynes/cm disposed over an inner surface of the reinforcement element; and (c) an additional porous polymeric layer formed over an outer surface of the reinforcement element.