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: Described herein are systems for partitioning a ventricle of a heart. The systems may include a partitioning device or implant, and an applicator for inserting, repositioning and/or removing the partitioning device. The implant may support the ventricle wall and may reduce the volume of the ventricle. In particular, described herein are systems for delivering and deploying a partitioning device into a ventricle. The delivery system may include a catheter having a distal coupling element for coupling to a partitioning device in a collapsed configuration; the catheter may also have an expansion member for applying force to the partitioning device to fully expand it into a deployed configuration and to secure or seal it against the ventricle wall.

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: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. 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.

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: Described herein are handle covers for use with one or more delivery catheters that may be used to deliver and/or remove an expandable cardiac implant. A handle cover may be formed from two interlocking pieces, and may include a control adapter that may be used to control release and/or attachment of an expandable implant. The control adapter may be configured to interact with an implant release control on the delivery catheter. The control adapter may also be lockable to prevent unintended activation of the implant release control. The handle cover may be reusable or disposable (e.g., single-use). In general, the implant control may be shaped so that hit may be held by a doctor, technician or other user, and may facilitate access to various components of the delivery catheter, including one or more ports (e.g., vacuum/inflation ports, etc.).

Abstract: Described herein are partitioning devices for reducing ventricular volume that may be secured within a ventricle and separate it into a productive portion and a non-productive portion. The partitioning devices described herein may include a reinforced membrane and may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating an inflatable element on the periphery of the device. All or a region of the non-productive portion formed by these devices may be enclosed within a container or bag. The non-productive portion may be filled with a material, including occlusive materials (e.g., vasoclusive coils). Sealing and/or filling the non-productive portion formed by the devices described herein may help prevent leakage from the non-productive region. Also described herein are systems including these devices and methods of using them, which may be suitable for treating patients with heart disease, particularly congestive heart failure.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. 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.

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: Apparatus and methods for positioning and securing anchors are disclosed herein. The anchors are adapted to be delivered and implanted into or upon tissue, particularly tissue within the gastrointestinal system of a patient. The anchor is adapted to slide uni-directionally over suture such that a tissue plication may be cinched between anchors. A locking mechanism either within the anchor itself of positioned proximally of the anchor may allow for the uni-directional translation while enabling the anchor to be locked onto the suture if the anchor is pulled, pushed, or otherwise urged in the opposite direction along the suture. This uni-directional anchor locking mechanism facilitates the cinching of the tissue plication between the anchors and it may be utilized in one or several anchors in cinching a tissue fold.

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: Systems for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.

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: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: 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: Partitioning devices that may be secured and sealed within a heart chamber for separating a patient's heart chamber into a productive portion and a non-productive portion are described herein. The partitioning devices described herein may include a reinforced membrane with outwardly biased members. The reinforced membrane may have 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. These devices may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating an inflatable element on the periphery of the device. The non-productive portion may be filled with a material, including occlusive materials. Sealing and/or filling the non-productive portion formed by the devices described herein may help prevent leakage from the non-productive region.

Abstract: 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: 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: 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: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.