Abstract: Embodiments of the present invention are directed to ablation catheter systems configured, for example, to ablate tissue adjacent an ostium of the pulmonary vein in a left atria of a heart. In one embodiment, an ablation catheter system includes a handle and a catheter coupled to the handle defining a lumen extending through a length of the catheter, the catheter including a distal end thereof. The ablation catheter system may also include an electrode coupled to the handle with lines extending through the lumen of the catheter, the electrode being configured to be constrained adjacent the distal end of the catheter and configured to be deployed from the distal end of the catheter to an expanded configuration.

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 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, 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: Embodiments of the present invention are directed to ablation catheter systems configured, for example, to ablate tissue adjacent an ostium of the pulmonary vein in a left atria of a heart. In one embodiment, an ablation catheter system includes a handle including an actuator and a catheter coupled to the handle defining a lumen extending through a length of the catheter, the catheter including a tip portion at a distal end thereof. The ablation catheter system may also include an electrode coupled to the handle with lines extending through the lumen of the catheter, the electrode being configured to be constrained within the tip portion of the catheter and configured to be deployed from the tip portion and self expand to an expanded configuration. With this arrangement, the electrode is configured to self expand to a conical configuration with a tip portion configured to be disposed within the pulmonary vein.

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 sleep surface insert system and method for positioning under, for example, an infant on a sleep surface. The sleep surface insert system includes an insert and a blower system. The insert includes a top liner and a bottom liner. The top liner and bottom liner define first and a second hollow spaces therebetween. Further, the top liner includes first and second pores such that the first pores extend through the top liner from the first hollow space and the second pores extend through the top liner from the second hollow space. In addition, the blower system is configured to provide air flow into the first and second hollow spaces defined in the insert such that the air flow is configured to flow into the insert and out of at least one of the first pores and the second pores.

Abstract: A method and system are provided for percutaneously gaining access to oxygenated bood with an anastomosis device and pumping such oxygenated blood to other arterial regions of the vascular 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 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 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 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: A medical device for reducing the size of a Patent Foramen Ovale is disclosed. The medical device can include a first electrode, a second electrode, and at least one sensor mounted to at least one of the first electrode or the second electrode, the at least one sensor adapted to sense at least one operating parameter of the medical device or the patient to facilitate closure of the Patent Foramen Ovale. The medical device can also include a delivery shaft coupled to the first electrode, wherein the delivery shaft includes an indicia for determining the position of the first electrode relative to the second electrode. A method for determining a characteristic of an internal tissue opening is also disclosed. The method can include the steps of introducing a detectable fluid in the right atrium of a heart and then detecting the location of the detectable fluid in the heart.

Abstract: Embodiments of the present invention are directed to ablation catheter systems configured, for example, to ablate tissue adjacent an ostium of the pulmonary vein in a left atria of a heart. In one embodiment, an ablation catheter system includes a handle including an actuator and a catheter coupled to the handle defining a lumen extending through a length of the catheter, the catheter including a tip portion at a distal end thereof. The ablation catheter system may also include an electrode coupled to the handle with lines extending through the lumen of the catheter, the electrode being configured to be constrained within the tip portion of the catheter and configured to be deployed from the tip portion and self expand to an expanded configuration. With this arrangement, the electrode is configured to self expand to a conical configuration with a tip portion configured to be disposed within the pulmonary vein.

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. 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 access the right atrium through the superior vena cave, grasp the filament, and withdraw the filament through the superior vena cave. The filament may then he 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 he discharged into the aorta.

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 delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

Abstract: A method and apparatus for remotely cannulating a body part are disclosed. The apparatus is an endoscopic cannulation apparatus having a fluid stasis assembly and a coring assembly. The fluid stasis assembly allows for the penetration of the body part and deployment of an occlusive device to prevent the escape of fluid during the coring and cannulation of the body part. The cannulation assembly allows for the coring of the body part without the introduction of air bubbles or other embolic materials into the patient. The method of the invention provides for the remote coring and cannulation of a body part such as a heart, blood vessels, the stomach, intestines, and other body parts with a sealed apparatus that may be de-aired to lessen the risk of the introduction of emboli into a system.

Abstract: A remote cannulation assembly is disclosed for rapidly cannulating a body part such as a heart during a medical procedure. Cannulation is often conducted in procedures such as the installation of a ventricular assist device. The cannulation assembly of the invention utilizes an isolation valve to create a sealed fluid environment for the procedure. The invention further includes a coring assembly that may be used with the cannulation apparatus. Methods of cannulating a heart or other body part are also disclosed in which the risk of emboli is reduced. Additionally, methods of connecting and disconnecting two fluid conducting elements are disclosed.

Abstract: Embodiments of the present invention are directed to ablation catheter systems configured, for example, to ablate tissue adjacent an ostium of the pulmonary vein in a left atria of a heart. In one embodiment, an ablation catheter system includes a handle including an actuator and a catheter coupled to the handle defining a lumen extending through a length of the catheter, the catheter including a tip portion at a distal end thereof. The ablation catheter system may also include an electrode coupled to the handle with lines extending through the lumen of the catheter, the electrode being configured to be constrained within the tip portion of the catheter and configured to be deployed from the tip portion and self expand to an expanded configuration. With this arrangement, the electrode is configured to self expand to a conical configuration with a tip portion configured to be disposed within the pulmonary vein.

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 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.