Abstract: Methods and apparatus for coating surfaces of medical devices by electroless plating are disclosed. In one embodiment, the invention includes a coating method in which a therapeutic agent and a plating material are plated onto the surface of the medical device by an electroless plating chemical reaction. In another embodiment, a coating method is disclosed in which the coating is formed by suspending a therapeutic agent in a soluble plating solution and plating a plating material onto the medical device by electroless plating wherein the plated material contains the suspended therapeutic agent. In another embodiment, a coating method is provided wherein the coating is formed by initially bonding a therapeutic agent to a plating material, and then plating the bonded therapeutic agent/plating material onto the medical device by electroless plating. In another embodiment, an additive is introduced to the soluble plating solution to regulate the chemical reaction of electroless plating.

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, 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: A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50° C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as 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., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.

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: 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: The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

Abstract: The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

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: The present invention provides a prosthetic heart valve that includes biologically active agents that retard or prevent the infiltration of fibrous tissue (“pannus”) from the host into the structure of the prosthetic valve. Preventing or decreasing the overgrowth of the prosthetic valve by pannus reduces the complications associated with the implantation and use of prosthetic heart valves.

Abstract: The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

Abstract: A coating and method for a coating an implantable device or prostheses are disclosed. The coating includes an undercoat of polymeric material containing an amount of biologically active material, particularly heparin, dispersed therein. The coating further includes a topcoat which covers less than the entire surface of the undercoat and wherein the topcoat comprises a polymeric material substantially free of pores and porosigens. The polymeric material of the topcoat can be a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.

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: 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 expelled due to the contraction of the muscle, such as the beating of a heart muscle.

Abstract: A coating and method for a coating an implantable device or prostheses are disclosed. The coating includes an undercoat of polymeric material containing an amount of biologically active material, particularly heparin, dispersed therein. The coating further includes a topcoat which covers less than the entire surface of the undercoat and wherein the topcoat comprises a polymeric material substantially free of pores and porosigens. The polymeric material of the topcoat can be a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.

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: The present invention provides methods of inactivating and removing infectious agents from tissues of use in bioprosthetic devices. The methods include the removal and blockage of binding sites on the tissues for the infectious agents. Also provided are methods for blocking a site on an infectious agent that binds to a site on the tissue.

Abstract: A balloon catheter having a perfusion lumen communicating with a blood vessel, and a magnetically driven impeller disposed in the perfusion lumen to increase blood flow through the catheter and the arteries.

Abstract: The present invention provides methods of inactivating and removing infectious agents from tissues of use in bioprosthetic devices. The methods include the removal and blockage of binding sites on the tissues for the infectious agents. Also provided are methods for blocking a site on an infectious agent that binds to a site on the tissue. The invention also provides a method for preventing or reducing the calcification of a bioprosthetic tissue. The method includes removing or blocking a phospholipid calcium nucleation site from the tissue.

Abstract: A method of coating implantable open lattice metallic stent prosthesis is disclosed which includes sequentially applying a plurality of relatively thin outer layers of a coating composition comprising a solvent mixture of uncured polymeric silicone material and crosslinker and finely divided biologically active species, possibly of controlled average particle size, to form a coating on each stent surface. The coatings are cured in situ and the coated, cured prosthesis are sterilized in a step that includes preferred pretreatment with argon gas plasma and exposure to gamma radiation electron beam, ethylene oxide, steam.