Abstract: A closure device for a patent foramen ovale (PFO) has proximal and distal occlusion members for applying compressive forces to tissue on opposite sides of septal defects to help close the defects. The devices are collapsible for delivery and deployment, and can be easily retrieved and redeployed or repositioned if needed.

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.

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: A septal occluder, such as one made from a polymer tube, can have portions on either side of a patent foramen ovale (PFO) or other septal defect. The portions on either side can be held in place with a catching mechanism that can take one of many forms. The tube can be made of bioresorbable materials.

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: 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: The invention provides a septal occluder for closing a patent foramen ovale (PFO). The septal occluder includes a flexible central portion connecting two occlusion shells for the percutaneous transluminal treatment of an intracardiac defect. The septal occluder includes two occlusion shells connected by an elongate member capable of pivoting or articulating. The elongate member pivots or articulates at the juncture of the occlusion shell and the elongate member, according to one embodiment, or in the center of the elongate member, according to another embodiment. The elongate member can have one or more pivot points.

Abstract: Disclosed herein are devices and methods for occluding intracardiac defects, such as a patent foramen ovale (PFO). The devices according to the invention have various features to improve flexibility and to enhance conformability of the device to the defect, including the incorporation of braided or multi-stranded wire. The invention also contemplates methods of making these devices.

Abstract: An implant for occluding a septal defect, such as a patent foramen ovale (PFO), and methods of delivering the implant are described. The implant includes a scaffold, at least one channel, and an injection port in fluid communication with the channels for inflating the scaffold.

Abstract: A septal occluder, such as one made from a polymer tube, can have portions on either side of a patent foramen ovale (PFO) or other septal defect. The portions on either side can be held in place with a catching mechanism that can take one of many forms. The tube can be made of bioresorbable materials.

Abstract: The present invention provides a device which is adapted to press together the septum primum and the septum secundum between the atrial chambers to close any tunnel in the septum. The device in its preferred form has two clamping members, one on each side of the septum and a central connector which connects the two clamping members and passes through the tunnel. The device is configured to conform to the anatomy such that the tunnel is not substantially deformed by the device. The central connector, in its preferred form has two wires that are spaced apart so that the wires are proximate the lateral sides of the tunnel. The spacing allows the device to be centered at an appropriate location.

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: The disclosed invention provides several alternative embodiments of devices that include center joints. The devices are adapted for use in a Patent Foramen Ovale (PFO) closure device. In one embodiment of the invention the center joint may be flexible and may have locking capacity to allow a PFO closure device to be delivered in a reduced profile and then locked into a deployed configuration. When the center joint is flexible the device can conform to the anatomy of the PFO. The device may include ends that cooperate with the center joint to allow a clamping function on the tissue to close the PFO. In another embodiment, the center joint expands to fill some or all of the PFO tunnel. In still another embodiment the center joint is designed to stretch the tunnel from side to side so that the inner surface of the tunnel collapses onto itself. In still another embodiment, the center joint can be inflatable, e.g., as with a balloon, so that the PFO tunnel is filled when the balloon is inflated.

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: The invention relates to an occluder for a percutaneous transluminal procedure. In one embodiment, the occluder includes an overall support structure and a plurality of occlusion shells connected to the overall support structure. At least one occlusion shell includes an electrospun fabric.

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.