Abstract: An improved method for high-volume production of coated stents with highly uniform stent coatings using a roll coating technique is provided. In a first embodiment, uncoated stents are placed onto rotating stent holders with automated stent handling equipment. The holders are mounted on an endless conveyer belt which advances the stents toward a stent coater. As the stents advance through the coater, the holders rotate, thereby rolling the stents about their longitudinal axes as coating material is sprayed toward them, ensuring the stents are uniformly coated on their exterior and interior surfaces. After the conveyer turns to carry the coated stents back toward the loading area, the rotating stents pass again through the coating spray, downstream of the initial coating location, thereby increasing the efficient utilization of the coating material. The conveyer then advances the coated stents to an unloading area for removal before the holders return to the stent loading area to receive new stents.

Abstract: A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing a laterally directed needle to increase injectate (fluid) retention in the heart tissue. The device may comprise a catheter having a shaft wherein the distal end of the shaft includes a primary penetrating member and a secondary penetrating member. The secondary penetrating member includes an injection lumen in fluid communication with a pressurized fluid source. The primary penetrating member penetrates the heart tissue at the injection site in a first direction, and the secondary penetrating member penetrates the heart tissue in a second direction different from the first direction such that fluid leakage from the injection site is reduced and the volume of treated tissue is increased.

Abstract: A device and method for delivering and injecting fluid into heart tissue utilizing a laterally directed needle to increase injectate (fluid) retention in the heart tissue. The device may comprise a catheter having a shaft wherein the distal end of the shaft includes a primary penetrating member and a secondary penetrating member. The secondary penetrating member includes an injection lumen in fluid communication with a pressurized fluid source. The primary penetrating member penetrates the heart tissue at the injection site in a first direction, and the secondary penetrating member penetrates the heart tissue in a second direction different from the first direction such that fluid leakage from the injection site is reduced and the volume of treated tissue is increased.

Abstract: A catheter for placement of an in situ implant is provided. This catheter may include a first elongate shaft having a proximal end and a distal end, a second elongate shaft having a proximal end and a distal end, a first sharpened distal tip disposed at the distal end of the first shaft and a second sharpened distal tip disposed at the distal end of the second shaft. The first shaft and the second shaft may also be secured to one another at the distal end of the first shaft according to the invention. Still further, according to other teachings, the first sharpened distal tip may extend beyond the second sharpened distal tip in a catheter that practices the invention.

Abstract: A method for delivering a therapeutic implant to a tissue is provided. This method includes providing an elongate catheter having a distal end including a lumen, providing a carrier including a therapeutic agent, placing the carrier including the therapeutic agent into the lumen, advancing the distal end of the catheter to the tissue, and depositing the carrier including the therapeutic agent into the tissue.

Abstract: The invention provides a system which comprises a medical device that delivers a combination of therapies. These therapies include the administration of radiation, biologically active materials, cryotherapy, and thermotherapy. The present invention is also directed to a method of treating body lumen surfaces using the system of the invention. A system is provided for delivering a biologically active material to a surface of a body lumen being exposed to a radioactive source. In one aspect, the system comprises an implantable medical device which has two opposing ends, each having a surface, and a middle portion. The two opposing ends comprise a biologically active material and the middle portion of the medical device is substantially free of any biologically active material. In another aspect, the system delivers a genetic material to a surface of a body lumen which is exposed to a radioactive source.

Abstract: An apparatus and method for catheter-based sensing and injection at a target site within a patient's body. An injection catheter is equipped with a electrodes at its distal end which contact the surface of a target site, such as an AV node of the heart. Electrical signals detected at the target site by the electrodes are fed via leads to the proximal end of the catheter, where they are received by a monitor, such as an EKG monitor. If the electrical signals satisfy predetermined criteria, a needle within the catheter is extended into the target site, and a therapeutic agent is injected into the target site.

Abstract: The invention is directed to an apparatus, such as a medical device, having a surface coated or covered with a decellularized extracellular matrix or having a component comprising the decellularized extracellular matrix for implantation into a subject, preferably a human. In one embodiment of the invention, a decellularized extracellular matrix is used to form a bodily implant such as a vein, an artery, an esophagus, or a ventricular restraining device. In some embodiments of the invention, the decellularized extracellular matrix is configured to be a time released therapeutic. In another embodiment of the invention, a decellularized extracellular matrix forms an aneurysm treatment device, such as an aneurysm coil, a seal, a pouch, or a filler. In a further embodiment of the invention, decellularized extracellular matrix is used to embolize lesions, tumors, or vessels.

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: An improved method and apparatus for high-volume production of coated stents with highly uniform stent coatings using a roll coating technique is provided. In a first embodiment, uncoated stents are placed onto rotating stent holders with automated stent handling equipment. The holders are mounted on an endless conveyer belt which advances the stents toward a stent coater. As the stents advance through the coater, the holders rotate, thereby rolling the stents about their longitudinal axes as coating material is sprayed toward them, ensuring the stents are uniformly coated on their exterior and interior surfaces. After the conveyer turns to carry the coated stents back toward the loading area, the rotating stents pass again through the coating spray, downstream of the initial coating location, thereby increasing the efficient utilization of the coating material.

Abstract: The invention provides a system which comprises a medical device that delivers a combination of therapies. These therapies include the administration of radiation, biologically active materials, cryotherapy, and thermotherapy. The present invention is also directed to a method of treating body lumen surfaces using the system of the invention. A system is provided for delivering a biologically active material to a surface of a body lumen being exposed to a radioactive source. In one aspect, the system comprises an implantable medical device which has two opposing ends, each having a surface, and a middle portion. The two opposing ends comprise a biologically active material and the middle portion of the medical device is substantially free of any biologically active material. In another aspect, the system delivers a genetic material to a surface of a body lumen which is exposed to a radioactive source.

Abstract: This invention provides methods of forming new blood vessels in diseased or damaged tissue in a subject, methods of increasing blood flow to diseased or damaged tissue in a subject, and methods of increasing angiogenesis in diseased tissue in a subject, which methods comprise: a) isolating autologous bone marrow-mononuclear cells from the subject; and b) transplanting locally into the diseased or damaged tissue an effective amount of the autologous bone-marrow mononuclear cells, thereby forming new blood vessels in the diseased or damaged tissue. The new blood vessels may be capillaries or collateral vessels in ischemic tissue or any site of angiogenesis. Also provided are methods of treating tissue in disease or injury by local transplantation with an effective amount of the autologous bone marrow-mononuclear cells so as to induce vascularization in such diseased tissue.

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: 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: 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: 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: An apparatus and method for delivering a viscous liquid therapeutic material fluid through a lumen in a catheter that selectively narrows the lumen at a plurality of axial locations along the lumen.

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 micro particles. Polymer microparticles, such as polystyrene microparticles, are one preferred class of microparticles. The microparticles preferably range from 0.

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.