Abstract: A device closes a patent foramen ovale (PFO), thus reducing or eliminating blood flow through the defect. The device is formed from a tubular structure having split ends, such that, after insertion, struts defined by the split ends pivot in a radial direction away from the tube, thereby securing the device within the septal defect.

Abstract: Patent foramen ovale (PFO) closure clip include two closure members, which may be heart shaped, joined by at least two spaced central connecting members. Each of the at least two spaced central connecting members is attached to each closure member at a location on the periphery of the closure member. The connecting member may be generally square shaped or include other shapes. The clips are designed such that the at least two central connecting members extend through the inclined PFO tunnel and the two closure members compress the overlapping layers of septal tissue, i.e. septum primum and septum secundum, together to close the PFO tunnel. The clips of the present invention may be formed of various materials, including metals, nonmetallic materials, bioresorbable polymers, spring steel, shape memory materials, bioresorbable shape memory polymers, or combinations thereof. The clips can take various forms depending, in part, upon the distribution of force required to close a given PFO.

Abstract: A delivery/recovery system to allow an operator to deploy and recover a medical implant, such as an occluder for closing a patent foramen ovale (PFO). In one embodiment, the system includes a delivery mandrel for preventing the occluder from moving in the proximal direction, a delivery wire for securing the occluder to the delivery mandrel and preventing unwanted movement in the distal direction, and a sheath for enveloping the delivery wire, mandrel and occluder. By moving the sheath relative to the occluder in a series of steps, the occluder opens first on a distal side and then on a proximal side, in a manner that holds the occluder in place.

Abstract: An occluder that has a coil on one or both sides of a medical defect, particularly a septal defect such as a patent foramen ovale (PFO). Each coil can be formed as a tube that is hollow, with or without a closed end. The tube can be delivered over a wire. For occluding a PFO, the coils can be designed to provide a compressive force to one or both of septum primum and septum secundum.

Abstract: Devices and methods are provided for opening the entrance (ostium) of the left atrial appendage to increase blood flow and thereby reduce the likelihood of thrombus formation therein by decreasing blood stagnation. The device can include a stent, an expandable foam, or a balloon anchor component, and can be provided in such a way so as to leave no implant behind.

Abstract: An opening other than the ostium of a left atrial appendage (LAA) is provided to allow blood flow between the LAA and another portion of the body. The opening has a conduit that helps to increase blood flow through an LAA by adding at least one other flow path to the ostium, thereby reducing the risk of stasis and the formation of thrombi.

Abstract: The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

Abstract: The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

Abstract: The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.

Abstract: A welding element is provided for applying heat, chemicals, pressure, or any combination thereof to tissues inside a patient's body, e.g., a patent foramen ovale. In one aspect, the welding element is connected to a radio frequency energy source and includes an electrode and a locator. The locator facilitates positioning of the welding element and is capable of moving from an open position to a clamping position. In another aspect, a needle is provided for transseptal puncturing before the application of heat. In yet another aspect, the welding element is configured as a coil. The welding element can be made of Nitinol.

Abstract: Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Abstract: The invention relates to devices, systems, and methods for percutaneously suturing biological material, such as a patient's tissues. In one embodiment, a suturing device includes first and second tissue engaging members connected to one another by a first interconnecting member. In another embodiment, systems and methods are provided for forming holes through two overlapping layers of tissue. Subsequent to forming holes through the two layers of tissue, the suturing device is positioned through the holes to join or bring into contact the two layers of overlapping tissue.

Abstract: The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Abstract: Apparatus, systems, and methods for forming a hole in biological material, such as tissue walls, adjacent vessels or adjacent regions of an organ such that access to opposing surfaces of the biological material can be achieved. In general overview the system may include an elongate member for positioning and deploying a flexible member in the heart. In one embodiment apparatus and methods are provided for aligning and fixing the position of the tip of a cutting member for cutting a hole in the septal wall of a heart. In another embodiment, subsequent to cutting a tissue wall an apparatus for obstructing holes in the septal wall is inserted to limit the flow of blood through a plurality of holes in a tissue wall.