Abstract: The present invention provides a method of sustaining direct delivery of cells into a target area. The method generally includes delivering cells to a target area. Specifically, the cells are introduced through an introduction site of a target area and delivered to the target area. The method further includes depositing at the introduction site, a plug member that contains a therapeutic agent that is released from the plug member to the target site. at the introduction site. The therapeutic agent generally acts to increase intracellular coupling between the grafted cells and the target area. The plug member also acts to seal the introduction site to inhibit cells from leaking from the introduction site into surrounding areas of the body.

Abstract: A modified medical device for delivery of a pharmaceutically active material is described. The present inventors have found that many conventional medical devices contain a metallic or polymeric component that comes into contact with a pharmaceutically active material during use, and that the contact substantially reduce the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to the metallic or polymeric component that are effective to diminish such a substantial reduction in pharmaceutical effectiveness.

Abstract: An apparatus for delivery of biologically active materials comprises a catheter and balloon having micro-needles or pores. In the apparatus, the balloon can have a polymer oating containing the biologically active material, and the apparatus can include a sheath surrounding the balloon. In one embodiment the biologically active material is delivered through lumens in the micro-needles. Another embodiment of the invention is an apparatus for delivery of biologically active materials comprising a catheter with a balloon disposed thereon and a shockwave generator for producing a shockwave for delivering the biologically active material to a body lumen. Methods for delivery of biologically active materials are also disclosed.

Abstract: A modified medical device for delivery of a pharmaceutically active material is described. The present inventors have found that many conventional medical devices contain a metallic component that comes into contact with a pharmaceutically active material during use, and that the contact substantially reduce the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns numerous modifications to the metallic component that are effective to prevent such a substantial reduction in pharmaceutical effectiveness.

Abstract: Methods of sealing an injection site of a tissue are provided, where therapeutic agent has been injected into tissue, resulting in increased efficiency or agent uptake. Also provided are methods for delivering therapeutic agent to a tissue, which include injecting a therapeutic agent into a tissue and subsequently sealing the injection site, or engaging an injection device with the tissue for a sufficient period of time that sealing is not necessary to avoid leakage of the therapeutic agent. In one embodiment radio frequency cautery is used to seal the injection site upon needle removal from the tissue. In other embodiments, the injection site is sealed by resistance heating, laser heating or plugging the site with a solid plug or coagulating material at the site.

Abstract: Method and apparatus for diagnostic and therapeutic agent delivery is provided by the present invention. In one embodiment a method for injecting an agent into the body of a patient is provided. This method includes: covering an injection structure having a piercing tip with a coating that contains a first agent; urging the piercing tip of the injection structure into a first target located in the body of the patient; and, maintaining the injection structure in the first target location for a predetermined amount of time. In so doing the agent may be conveniently and accurately delivered to the target site. In another embodiment of the present invention a drug delivery device is provided. This drug delivery device includes a catheter having a proximate end and a distal end and an injection structure coupled to the distal end of the catheter. In this embodiment the catheter is covered with a coating that contains an agent.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing laterally directed injection ports to increase injectate (fluid) retention in the heart tissue. The catheter includes a shaft having an infusion lumen extending therethrough, wherein the distal end of the shaft includes a penetrating member having one or more injection ports. The penetrating member penetrates the heart tissue in a first direction, and the injection port or ports direct fluid in a second direction different from the first direction. By injecting the fluid or fluid in a direction different than the penetration direction, fluid leakage from the injection site is reduced and a greater volume of tissue is treated for a single primary injection.

Abstract: Methods of sealing an injection site of a tissue are provided, where therapeutic agent has been injected into tissue, resulting in increased efficiency or agent uptake. Also provided are methods for delivering therapeutic agent to a tissue, which include injecting a therapeutic agent into a tissue and subsequently sealing the injection site, or engaging an injection device with the tissue for a sufficient period of time that sealing is not necessary to avoid leakage of the therapeutic agent. In one embodiment radio frequency cautery is used to seal the injection site upon needle removal from the tissue. In other embodiments, the injection site is sealed by resistance heating, laser heating or plugging the site with a solid plug or coagulating material at the site.

Abstract: Disclosed herein is an implantable or insertable therapeutic agent delivery device comprising a coating material provided on at least a portion of said device, said coating material prohibiting substantial release therefrom of a therapeutic agent at or below about a physiological pH and allowing substantial release therefrom of a therapeutic agent at or above about said physiological pH. Also disclosed herein are coating materials for the implantable or insertable therapeutic agent delivery device. The coating materials are preferably polymers derivatized to contain moieties that are cationically charged at a pH below their pKa values and which thus can attract negatively charged therapeutically agents at pH values below their pKa values and which become predominantly uncharged at pH values above about their pKa values and thus substantially release the negatively charged therapeutic agents at such pH values, which are preferably about physiological pH.

Abstract: The present invention relates to a medical device and method for treating the body tissue of a patient. The present invention is also directed to a method of making the medical device and a method of using the medical device. More particularly, the invention relates to a medical device which is inserted into the body for delivery of therapeutic patches to the surface of a body lumen, organ or cavity. Specifically, the medical device has an umbrella-like or a basket-like expandable assembly; and a therapeutic patch. The expandable assembly is capable of changing from a retracted position to an expanded position. The expandable assembly can be self-expanding or non-self-expanding. In one embodiment, the medical device comprises an elongated member; an umbrella-like expandable assembly which has a plurality of wire elements; and a therapeutic patch.

Abstract: Disclosed herein is an implantable or insertable therapeutic agent delivery device comprising a coating material provided on at least a portion of said device, said coating material prohibiting substantial release therefrom of a therapeutic agent at or below about a physiological pH and allowing substantial release therefrom of a therapeutic agent at or above about said physiological pH. Also disclosed herein are coating materials for the implantable or insertable therapeutic agent delivery device. The coating materials are preferably polymers derivatized to contain moieties that are cationically charged at a pH below their pKa values and which thus can attract negatively charged therapeutically agents at pH values below their pKa values and which become predominantly uncharged at pH values above about their pKa values and thus substantially release the negatively charged therapeutic agents at such pH values, which are preferably about physiological pH.

Abstract: The present invention is directed to the use of microparticles to protect the pharmaceutical effectiveness of a pharmaceutically active agent. According to one embodiment, a pharmaceutically acceptable suspension is provided that comprises microparticles and a pharmaceutically active agent. This pharmaceutically acceptable suspension is then exposed to a component or condition that is incompatible with the pharmaceutically active agent, such that the microparticles provide a pharmaceutical effectiveness that is greater than it would have been in the absence of the microparticles. Preferably, the microparticles result in a pharmaceutical effectiveness of the pharmaceutically active agent that is at least 10% greater than the pharmaceutical effectiveness of the pharmaceutically active agent would have been in the absence of the microparticles. Polymer microparticles, such as polystyrene microparticles, are one preferred class of microparticles. The microparticles preferably range from 0.

Abstract: This invention relates to a method of treating ischemic or diseased myocardium by injecting a therapeutic agent, such as a gene, protein, cell or drug, into normal myocardium, preferably adjacent to an ischemic zone in the heart of a subject. The method is useful for inducing angiogenesis and collateral blood vessel formation to improve cardiac function in subjects with ischemic heart disease. The method can also be used to promote tissue regeneration in such subjects.

Abstract: The present invention regards a therapeutic delivery balloon and includes a system for delivering therapeutic to an irregular interior vessel surface. This system includes a catheter having a proximal end, a distal end, and an internal lumen; a source of fluid in communication with the internal lumen of the catheter; and, a first inflatable balloon having an exterior surface, wherein the balloon is hyper-deformable, is in communication with the internal lumen of the catheter, and has an exterior surface in communication with a therapeutic when the balloon is in expanded state.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing laterally directed injection ports to increase injectate (fluid) retention in the heart tissue. The catheter includes a shaft having an infusion lumen extending therethrough, wherein the distal end of the shaft includes a penetrating member having one or more injection ports. The penetrating member penetrates the heart tissue in a first direction, and the injection port or ports direct fluid in a second direction different from the first direction. By injecting the fluid or fluid in a direction different than the penetration direction, fluid leakage from the injection site is reduced and a greater volume of tissue is treated for a single primary injection.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: Medical devices and systems for the localized delivery of genetic information to a target location within a mammalian body. In one embodiment, the system comprises a medical device insertable into the body and a biostable coating over at least part of the medical device. Genetic information is incorporated into the biostable coating before the medical device is placed into the body, and is released from the biostable coating at a target location within the body. The invention also includes methods for the localized delivery of genetic information to target locations within a mammalian body using the medical devices and systems of the invention.

Abstract: Many conventional pharmaceutical articles contain seemingly inert components that come into contact with a pharmaceutically active material during use, which contact substantially reduces the pharmaceutical effectiveness of the pharmaceutically active material. The invention described herein concerns various modifications to these incompatible components, which are effective to diminish the reduction in pharmaceutical effectiveness.

Abstract: A method of site-specifically delivering a therapeutic agent to a target location within a body cavity, vasculature or tissue. The method comprises the steps of providing a medical device having a substantially saturated solution of therapeutic agent associated therewith; introducing the medical device into the body cavity, vasculature or tissue; releasing a volume of the solution of therapeutic agent from the medical device at the target location at a pressure of from about 0 to about 5 atmospheres for a time of up to about 5 minutes; and withdrawing the medical device from the body cavity, vasculature or tissue. In another aspect, the present invention includes a system for delivering a therapeutic agent to a body cavity, vasculature or tissue, comprising a medical device having a substantially saturated solution of the therapeutic agent associated therewith.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.