Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point. Adjustable anchor assemblies, as well as anchor delivery systems, are also provided.

Abstract: Described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber to support the affected region within 72 hours after myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device.

Abstract: This invention is directed to a partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber and a support or spacing member extending between the reinforced membrane and the wall of the patient's heart chamber. The support or spacing member has a non-traumatic distal end to engage the ventricular wall.

Abstract: Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point, moving the first tissue contact point from a position initially distal to a second tissue contact point to a position proximal of the second contact point to form a tissue fold, and extending an anchor assembly through the tissue fold near the second tissue contact point. Adjustable anchor assemblies, as well as anchor delivery systems, are also provided.

Abstract: This invention is directed to a partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber and a support or spacing member extending between the reinforced membrane and the wall of the patient's heart chamber. The support or spacing member has a non-traumatic distal end to engage the ventricular wall.

Abstract: An apparatus for treating an occlusive region of a blood vessel includes a catheter including a first lumen extending from an end port to a first side port, and a second lumen extending from a proximal end of the catheter to a second side port. A balloon is mounted on the catheter between the first and second side ports. During use, a guidewire is placed into an occlusive region, and the guidewire is backloaded through the first and second lumens. The catheter is advanced over the guidewire, and the balloon is expanded to isolate the occlusive region. The guidewire is removed, and an agitator is advanced through the second lumen. After the agitator is agitated to dislodge occlusive material from the occlusive region, the agitator is removed, and the loose occlusive material is aspirated via the second side port.

Abstract: This invention is directed to a partitioning device for separating a chamber of a patient's heart into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a frame-reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber. Elements of the frame include ribs that are secured to the expandable membrane, to form an integrated structure that may be unilaminar or bilaminar in form. The proximal ends of the ribs of the frame have tissue-penetrating elements about the periphery thereof which are configured to penetrate tissue lining the heart wall at an angle approximately perpendicular to a longitudinal axis of the partitioning device. The partitioning device has a hub with a non-traumatic distal end to engage the ventricular wall.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: The present invention provides improved devices and methods for replacing or repairing a malfunctioning heart valve. In particular, improved minimally invasive methods and devices are provided for percutaneous transcatheter implantation of expansible prosthetic heart valves within or adjacent a valved anatomic site within the heart. In one embodiment, an expansible prosthetic heart valve comprises an implantable structure, a flexible membrane, and a membrane support. The implantable structure is expansible from a first reduced diameter to a second enlarged diameter and has a flow path therethrough. The flexible membrane is positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction. The membrane support is positionable in the flow path and affixed to the implantable structure.

Abstract: Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: The present invention provides improved devices and methods for replacing or repairing a malfunctioning heart valve. In particular, improved minimally invasive methods and devices are provided for percutaneous transcatheter implantation of expansible prosthetic heart valves within or adjacent a valved anatomic site within the heart. In one embodiment, an expansible prosthetic heart valve comprises an implantable structure, a flexible membrane, and a membrane support. The implantable structure is expansible from a first reduced diameter to a second enlarged diameter and has a flow path therethrough. The flexible membrane is positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction. The membrane support is positionable in the flow path and affixed to the implantable structure.

Abstract: This invention is directed to a partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion which is suitable for treating patients with heart disease, particularly congestive heart failure. The partitioning device has a reinforced membrane with outwardly biased members to help seal the periphery of the membrane against the wall of the patient's heart chamber. In one embodiment, the outwardly biased member is an expansive strand that extends between adjacent ribs of an expandable frame which reinforces the membrane. In another embodiment, the outwardly biased member is a hydrophilic body such as foam which swells upon contact with body fluid such as blood in the heart chamber. The reinforced membrane has a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: A method and device for the treatment of a patient with heart disease and particularly a heart chamber having a myocardial rupture or characteristics of an incipient myocardial rupture. The heart chamber is partitioned so as to isolate a non-productive portion having a rupture or a region of an incipient rupture from a productive portion. The heart chamber is preferably partitioned with a reinforced membrane which has a pressure receiving surface that defines part of the productive portion of the heart chamber. The peripheral base of the reinforced membrane may have an eccentric configuration.

Abstract: Disclosed is an adjustable occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Abstract: This invention is directed to a system and method for partitioning a patient's heart chamber into a productive portion and a non-productive portion which are particularly suitable for treating patients with congestive heart failure. The partitioning system has a plurality of partitioning devices with reinforced, expandable membranes which separate the productive and non-productive portions of the heart chamber. When deployed within the patient's heart chamber, the second partitioning device is off-set from the deployed first partitioning device to cover a region of the wall defining the patient's heart chamber which is not covered by the first partitioning device. The multiple partitioning devices may be independent from each other or may be interconnected, e.g. a tether or strand.

Abstract: Disclosed is an apparatus for facilitating access to the left atrium, and specifically the left atrial appendage. The apparatus may comprise a sheath with first and second curved sections that facilitate location of the fossa ovalis and left atrial appendage. The apparatus may further comprise tissue piercing and dilating structures. Methods are also disclosed.

Abstract: This invention is directed to a device and method of using the device for partitioning a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The device has an inflatable partitioning element which separates the productive and non-productive portions of the heart chamber and in some embodiments also has a supporting element, which may also be inflatable, extending between the inflatable partitioning element and the wall of the non-productive portion of the patient's heart chamber. The supporting element may have a non-traumatic distal end to engage the ventricular wall or a tissue penetrating anchoring element to secure the device to the patient's heart wall.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, agitate the clot and agent, and aspirate broken-up clot from the blood vessel. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.