Abstract: Medical devices, systems and methods for treating valve prolapse in, for example, the mitral valve. The medical device is employed by delivering the device percutaneously and lodging the device adjacently above the valve. With this arrangement, the device provides a back-stop to prevent valve prolapse and, thus, prevent valve regurgitation.

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: Several embodiments are set forth of devices, systems and methods for modifying an atrial appendage such as a left atrial appendage (LAA). In one embodiment, a device includes a body that is collapsible and self-expanding. The body includes a textured surface with protruding portions and recessed portions. The body may be formed of a reticulated foam material and may exhibit a substantially spherical geometry or a truncated spherical geometry. The body may be substantially hollow. In one embodiment, portions of the textured surface may be metalized or have a coating placed thereon to enhance frictional engagement of the body with the atrial appendage wall. In another embodiment, a mesh bag is disposed within an LAA and one or more self-expanding bodies are disposed within the mesh bag. The mesh bag is then secured to retain the self-expanding bodies within the bag and the LAA.

Abstract: The present invention provides devices, systems and methods for closing a paravalvular leak. In accordance with one embodiment, a medical device includes at least one multicellular frame member configured to be implanted at a paravalvular leak. The medical device further includes at least one tissue in-growth member associated with the frame member, the tissue in-growth member being configured to promote tissue growth and permanently maintain the frame member at the leak. The frame member may be self expanding device formed, for example, of a shape-memory alloy. The tissue in-growth member may be formed from a polymer material. In one particular embodiment, the frame member may be a substantially tubular structure and the tissue in-growth member may be disposed within an interior space defined by the tubular structure. In another embodiment, the frame ember may be a substantially flat or planar structure.

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 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 can include a member adapted to induce tissue growth. The anchors can extend from the body portion and return back to the body portion to define a closed periphery. The anchors can include undulations and can include multiple segments. A method of forming a closure device can include positioning a material on a working surface and cutting a closure device from the material.

Abstract: A medical system for treating an internal tissue opening can include a closure device and associated delivery device. 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. The delivery device can include a tip member coupled to the distal end of a catheter. The tip member can include a first passageway and a second passageway being in a spaced apart arrangement. A guidewire can be received into the first passageway to facilitate positioning of the delivery device. The second passageway can house and facilitate delivery of the closure device.

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. A segment can define a variable width along a length of the segment to have a substantially equal stress level along the length when deflected. The closure device can be configured to apply lateral force to tissue of the internal tissue opening to bring tissue together for closure. 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. The closure device can also include a member adapted to induce tissue growth.

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 also include an ingrowth 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.

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 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 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. A method of measuring a characteristic of a PFO or verifying placement of the closure device can include positioning the closure device in the PFO and utilizing two or more indicators to determine a characteristic of the PFO, such as tunnel width, or estimating placement of the closure 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 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.