Abstract: Methods and devices for diagnosis and treatment of cardiac conditions through the pericardial space are disclosed which are particularly suited for performing minimally invasive procedures from the surface of the heart including electrophysiology mapping and ablation, drug delivery, restenosis prevention, stent placement, etc. Some embodiments of a device disclosed herein can also be used advantageously to perform a medical procedure in a selected lumen of a patient's body.

Abstract: A method for treating the heart and associated vessels and tissues, by controlling the temperature of the pericardial space and/or introducing therapeutic agents, drugs or the like thereto, includes providing a fluid, liquid(s), gas(es) or mixtures thereof, with or without therapeutic agents, drugs or the like, and heating and/or cooling, this fluid. At a time proximate to the heating and/or cooling of the fluid, the pericardial space is accessed by pericardiocentesis, such that the pericardium is punctured and the pericardial space is instrumentized at a location, and in particular, a location where treatment is desired. The heated and/or cooled fluid is then delivered to the pericardial space. At a time after delivery, the fluid is withdrawn from the pericardium, through either the same catheter, or through another catheter at different point along the pericardium, that was also instrumentized (catheterized) by standard pericardiocentesis procedures.

Abstract: There is provided an apparatus and a method of using the apparatus for creating a bleb of tissue of the pericardium of the heart, for accessing the pericardial space, intermediate the pericardium and the heart, and withdrawing fluid therefrom or delivering fluid, including drugs, therapeutic agents, or the like, thereto. The apparatus of the present invention includes a shaft with a first distal end and a second proximal end. A bore extends through the shaft from the distal end to the proximal end. The first end includes jaws, that open and close, as at least one of the jaws is movable. The second end includes a handle, at least a portion of the handle in communication with a mechanism in communication with the movable jaw, such that upon movement of at least a portion of the handle, the jaws can be opened and closed continuously.

Abstract: The invention is directed to a device and method for minimally invasive access to the pericardial space of a human or animal patient. The disclosed pericardial access device includes a penetrating body axially mobile within the lumen of a guide tube. The guide tube includes a deflecting mechanism for deflecting the distal end of the penetrating body. In use, a patient's pericardium is contacted with the distal end of the guide tube and suction is applied to form a pericardial bleb. The penetrating body is axially mobilized distally within the lumen of the guide tube until the deflecting mechanism deflects the penetrating body to cause the penetrating end of the penetrating body to enter the bleb of pericardial tissue at an angle oblique to the longitudinal axis of the guide tube.

Abstract: There is provided an apparatus and a method of using the apparatus for creating a bleb of tissue of the pericardium of the heart, for accessing the pericardial space, intermediate the pericardium and the heart, and withdrawing fluid therefrom or delivering fluid, including drugs, therapeutic agents, or the like, thereto. The apparatus of the present invention includes a shaft with a first distal end and a second proximal end. A bore extends through the shaft from the distal end to the proximal end. The first end includes jaws, that open and close, as at least one of the jaws is movable. The second end includes a handle, at least a portion of the handle in communication with a mechanism in communication with the movable jaw, such that upon movement of at least a portion of the handle, the jaws can be opened and closed continuously.

Abstract: Methods of amelioration, treatment and prevention for restenosis and related disorders are provided. Methods involve the administration of nitric oxide by a nitric oxide delivery means comprising a restenosis-ameliorating or therapeutically/prophylactically effective amount of either a polymer to which is bound a nitric oxide-releasing N.sub.2 O.sub.2.sup.- functional group a compound comprising a nitric oxide-releasing N.sub.2 O.sub.2.sup.- functional group. Also provided are nitric oxide delivery means comprising such nitric oxide-releasing polymers or compounds for use in such methods. Preferably, the delivery means is coated with a nitric oxide-releasing polymer, which may be biodegradable, and enables the controllable and predictable release of NO to a given site in such a manner that effective ameliorating, prophylactic or therapeutic dosing is realized.

Abstract: Novel complexes of nitric oxide (NO) and amines are described where the amine is a known cardiovascular agent having at least one or more primary or secondary amino groups and whereby the resulting complex is capable under physiological conditions of releasing in vivo dual active ingredients, the NO and the known cardiovascular agent. The complexes are used for treating cardiovascular diseases and for the prophylactic or therapeutic treatment of restenosis.