Abstract: Disclosed is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.

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: The present invention provides a catheter and catheter assembly for delivering micronized therapeutic agents to a target site in the body and, in particular, to a target site in the heart. The micronized therapeutic agents are delivered in aerosol form or dry powder form. The present invention also provides a method of delivering micronized therapeutic agents to a target site in the body by placing the therapeutic agents in a catheter, positioning the catheter in the target site, and exposing the therapeutic agents to an energizing mechanism sufficient to create supersonic flow to carry the therapeutic agents from a stationary state in the catheter to a mobile state towards the target site.

Abstract: The present invention relates to microarray polymeric barriers designed to control the release rate of therapeutic agents. By varying the thickness of the coating or affecting, physically and/or chemically, the constituents of the barrier composition, the release profile of the underlying therapeutic agent can be modified and controlled.

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.

Abstract: The present invention provides a catheter and catheter assembly for delivering micronized therapeutic agents to a target site in the body and, in particular, to a target site in the heart. The micronized therapeutic agents are delivered in aerosol form or dry powder form. The present invention also provides a method of delivering micronized therapeutic agents to a target site in the body by placing the therapeutic agents in a catheter, positioning the catheter in the target site, and exposing the therapeutic agents to an energizing mechanism sufficient to create supersonic flow to carry the therapeutic agents from a stationary state in the catheter to a mobile state towards the target site.

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: Disclosed is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.

Abstract: Implants and methods for the delivery of a therapeutic agent to a target location within a patient's body are disclosed. The implants include a fiber comprising a polymeric material and having a diameter of up to about twenty microns, and a first therapeutic agent within the fiber. The therapeutic agent is substantially in particulate form. The implants are of a variety of configurations, such as individual fibers, yarns, ropes, tubes, and patches.

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: 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: 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 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: A medical device includes a carrier and an agent. The agent is formulated to control inflammation of biological tissue, such as heart tissue, and is releasably coupled to the carrier. The carrier is configured to be disposed in operative proximity to the biological tissue to be treated by the agent. In one embodiment, the carrier is configured to release the agent or otherwise deliver the agent to the biological tissue, thus controlling inflammation of the tissue. Also, a method to improve healing of biological tissue includes placing a medical device proximate to the heart of a patient, where the medical device has a carrier and an agent configured to control inflammation, the agent is releasably coupled to the carrier. In one embodiment, the method includes causing the agent to be released from the carrier.

Abstract: A catheter having a drug delivery unit at the distal end thereof. The drug delivery unit includes an actuator capable of assuming an activated and an inactivated configuration. The drug delivery unit also includes a receptacle capable of accepting a therapeutic agent. The actuator and receptacle are in communication with each other such that the actuator transmits force to the receptacle and the receptacle accepts force from the actuator in an activated configuration of the actuator. Also provided is a method of delivering a therapeutic agent to a target site using the catheter of the present invention.

Abstract: Devices and methods of delivering therapeutic agents to tissue are provided, which provide reduced outflow of therapeutic agents from an injection site. The methods include delivering one or more clot-promoting substances, such as platelets, fibrin and/or thrombin, to the injection site to entrap the therapeutic agent in the injection site. Devices include devices that are suitable for use in the provided methods.

Abstract: There is provided a minimally-invasive smart device which can detect environmental conditions in the vicinity of a target site within a patient's body and autonomously determine whether the medical device on the distal end of the instrument should be activated to perform, or inhibited from performing, a desired minimally-invasive medical procedure. The smart device includes a medical device affixed to the distal end of a lumen, at least one environmental condition sensor adapted to detect an environmental condition adjacent to the medical device, and at least one medical device actuator which responds to signals from an environmental condition sensor to either cause the medical device to perform the desired medical procedure or to inhibit operation of the medical device actuator.

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: The present invention relates to a biocompatible, three-dimensional scaffold useful to grow cells and to regenerate or repair tissue in predetermined orientations. The scaffold is particularly useful for regeneration and repair of cardiac tissue. The scaffold contains layers of alternating A-strips and S-strips, wherein the A-strips within each layer are aligned parallel to each other and preferentially promote cellular attachment over attachment to the S-strips. Methods of producing and implanting the scaffold are also provided.

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 coating 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: 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 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.