Abstract: A method and system are provided for percutaneously gaining access to oxygenated blood with an anastomosis device and pumping such oxygenated blood to other arterial regions of the vascular system via an LVAD system. In one embodiment, a system may include an anastomosis device extending through an opening of the atrial septum. A filament may be coupled to the anastomosis device. A snare device may access the right atrium through the superior vena cava, grasp the filament, and withdraw the filament through the superior vena cava. The filament may then be used as a guide to direct a catheter, a conduit or some other structure into the right atrium of the heart via the superior vena cava. A flow path may be defined between the anastomosis device and an arterial location, such as in the aorta, such that at least some oxygenated blood may by-pass the left ventricle and be discharged into the aorta.

Abstract: A medical system and device for use in delivering RF energy to a tissue opening and a method for determining an RF dose is disclosed. In one embodiment, the medical device includes an electrode or anchor and one or more devices, such as an impedance electrode, RF electrode and/or thermocouple. The electrode or anchor can be deployed from a delivery shaft inside the left atrium, for example, of a heart and substantially conform to the tissue proximate the tissue opening. Tissue characteristics, such as temperature and/or impedance, can be measured, before, during and after application of RF energy to the tissue, by one or more devices to determine an RF dose. After energy is applied to the tissue between the left and right electrodes, the left electrode can be removed from the left atrium by being received back into the delivery shaft and the delivery shaft thereafter removed from the opening.

Abstract: A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a multi-cellular body portion operatively associated with a first anchor and a second anchor. The closure device can be configured to apply lateral force to tissue of the internal tissue opening for tissue approximation. The closure device can have a substantially flat aspect, and have a depth that is substantially greater than the thickness of a majority of the members forming the closure device. The closure device can also include an in-growth material. The delivery device can include an actuating assembly configured to partially deploy the closure device by a first movement, and deploy a second portion of the closure device by a second movement. The delivery device can also include a release assembly to selectively release or disconnect the closure device from the delivery device.

Abstract: A medical device is disclosed that can include a first atrial anchor, a first delivery shaft linked to the first atrial anchor, wherein the first delivery shaft is adapted to move the first atrial anchor, a second atrial anchor, a second delivery shaft linked to the second atrial anchor, wherein the second delivery shaft is adapted to move the second atrial anchor, and a biasing member linking either (i) the first atrial anchor to the first delivery shaft or (ii) the second atrial anchor to the second delivery shaft. The medical device can include an insulation material coupled to one or more of the first or second atrial anchors, or the first or second delivery shaft. A method for treating an internal tissue opening is also disclosed wherein a first and second electrode can be operated between unipolar and bipolar modes to initiate tissue damage, thereby inducing tissue regrowth.

Abstract: A method and system are provided for percutaneously gaining access to oxygenated blood with one or more anastomosis devices and pumping such oxygenated blood directly to the aorta adjacent to the right atrium or left atrium via a VAD system. In one embodiment, a VAD system can be implanted with open surgery.

Abstract: A medical device is disclosed that can include a first atrial anchor, a first delivery shaft linked to the first atrial anchor, wherein the first delivery shaft is adapted to move the first atrial anchor, a second atrial anchor, a second delivery shaft linked to the second atrial anchor, wherein the second delivery shaft is adapted to move the second atrial anchor, and a biasing member linking either (i) the first atrial anchor to the first delivery shaft or (ii) the second atrial anchor to the second delivery shaft. The medical device can include an insulation material coupled to one or more of the first or second atrial anchors, or the first or second delivery shaft. A method for treating an internal tissue opening is also disclosed wherein a first and second electrode can be operated between unipolar and bipolar modes to initiate tissue damage, thereby inducing tissue regrowth.

Abstract: A medical device for use in delivering RF energy to a tissue opening is disclosed. In one embodiment, the medical device comprises a compliant electrode. The compliant electrode can include a shape memory material, such as NITINOL, to facilitate the electrode having at least one relaxed orientation. The electrode can be deployed from a delivery shaft inside the left atrium, for example, of a heart through the delivery shaft. The electrode can be configured to substantially conform to the tissue proximate the tissue opening. After energy is applied to the tissue between the left and right electrodes, the left electrode can be removed from the left atrium by being received back into the delivery shaft and the delivery shaft thereafter removed from the opening.

Abstract: A medical device, system and method for modifying a left atrial appendage (“LAA”). The medical device system includes a tether anchored within the LAA and one or more tissue growth members or occluders configured to be slid over the tether and lodged within the LAA. With this arrangement, a physician may close-off the LAA with a selective number of tissue growth members to meet the varying LAA sizes as determined from imaging information while conducting the procedure.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Abstract: A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a body portion operatively associated with a first anchor and a second anchor. The body portion can include a plurality of segments defining a multi-cellular structure. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together. The closure device can have a substantially flat aspect, and have a depth thickness that is substantially greater than the thickness or width of a majority of the members forming the closure device to reduce out of plane bending. The closure device can also include a member adapted to induce tissue growth.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Abstract: A medical device for use in delivering RF energy to a tissue opening is disclosed. In one embodiment, the medical device comprises a compliant electrode. The compliant electrode can include a shape memory material, such as NITINOL, to facilitate the electrode having at least one relaxed orientation. The electrode can be deployed from a delivery shaft inside the left atrium, for example, of a heart through the delivery shaft. The electrode can be configured to substantially conform to the tissue proximate the tissue opening. After energy is applied to the tissue between the left and right electrodes, the left electrode can be removed from the left atrium by being received back into the delivery shaft and the delivery shaft thereafter removed from the opening.

Abstract: A medical device and system for modifying a left atrial appendage (“LAA”), as well as related methods, are provided. In accordance with one embodiment, a medical device includes a plurality of discrete frame segments coupled with at least one ring member to form a frame structure. Each discrete frame segment includes an expanding leg, a collapsing leg and a hub extension. A tissue growth member is coupled with the plurality of discrete frame segments to define a substantially convex surface and a substantially concave surface.

Abstract: Medical devices, systems and methods for modifying a left atrial appendage (“LAA”). In one embodiment, a medical device system includes a jailing member or structure positioned over the ostium of an LAA and at least one tissue growth member positioned within the LAA and retained within the LAA by the jailing member. In another embodiment, a medical device includes an atrial stent coupled with a patch that is configured to cover the ostium of an LAA. The patch may have a tissue growth member associated therewith. In another embodiment, the patch may include an open-cell frame which may be used as a jailing member or structure.

Abstract: Devices, systems and methods for retrieving clot material from a vasculature lumen are provided. In one embodiment, a medical device includes a handle, a catheter, a tether member and a clot retrieval element. The catheter extends from the handle and the clot retrieval element is configured to be positioned within a distal portion of the catheter with the tether member extending between the handle and the clot retrieval element. The clot retrieval element is configured to be deployed from within the catheter so that the catheter moves proximally relative to and separate from the clot retrieval element while maintaining attachment to the clot retrieval element via the tether member. Further, the clot retrieval element is configured to be pulled by the tether member to abut against a distal side of a clot with proximal movement of the tether member to pull the clot from the vasculature lumen.

Abstract: A method and system are provided for percutaneously gaining access to oxygenated blood with an anastomosis device and pumping such oxygenated blood to other arterial regions of the vascular system via an LVAD system. In one embodiment, a system may include an anastomosis device extending through an opening of the atrial septum. A filament may be coupled to the anastomosis device. A snare device may access the right atrium through the superior vena cava, grasp the filament, and withdraw the filament through the superior vena cava. The filament may then be used as a guide to direct a catheter, a conduit or some other structure into the right atrium of the heart via the superior vena cava. A flow path may be defined between the anastomosis device and an arterial location, such as in the aorta, such that at least some oxygenated blood may by-pass the left ventricle and be discharged into the aorta.

Abstract: An apparatus, method and system directed to treatment of aneurysms are disclosed. In one embodiment a medical device delivery system may include a handle, a controller coupled to the handle and a catheter coupled to the handle. The delivery system may also include multiple embolic elements. Each of the embolic elements are positioned in a distal portion of the catheter in a compressed configuration and lined in a row within the distal portion of the catheter. The embolic elements are configured to be separately and discretely released from the catheter to be freely and randomly positioned within an aneurysm cavity and are each configured to self expand to an configuration larger in size than the compressed configuration.

Abstract: Delivery systems for a medical device and related methods are provided. In one embodiment the delivery system includes a handle, a handle extension, and a sleeve. The handle extension extends from the handle and includes at least one channel defined therein along a longitudinal length of the handle extension. The handle extension also includes an abutment surface positioned in the at least one channel. The sleeve is disposed around the handle extension and is coupled to a catheter. The sleeve also includes a biased actuator configured to be moved between at least two actuator positions. The sleeve is moveable from a distal position to an intermediate position where it is stopped via the abutment surface to partially unsheathe a medical device from the catheter. The actuator can then be manually actuated to enable displacement of the sleeve to a proximal position to fully unsheathe the medical device from the catheter.