W. L. Gore & Associates, Inc.

Hologic, Inc.

Cytyc Corporation

Nmt Medical, Inc.

David J Callaghan

Sean Forde

Erik Glaser

Andrzej J Chanduszko

Steven W Opolski

Jeffrey B Model

Carol A Devellian

James J Scutti

Matthew LaPlaca

Mark Putnam

Ryan Cahill

Stephanie M Kladakis

Todd A Peavey

James Duronio

Steve W Opolski

John Ahern

Timothy J Fallon

Eric Glaser

Noel McLellan

Matthew La Placa

Noel Mclellan

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. In some embodiments, the occluder is formed from filaments that are joined together to define a substantially cylindrical form with openings defining struts. 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. 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 engaged so that the occluder closes the aperture.

Patent foramen ovale (PFO) closure device with linearly elongating petals

Occluder devices for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO) comprise two sides connected by a central tube. The occluder devices are 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 devices include a catch system that maintains its deployed state in vivo. When an occluder device 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 device exerts a compressive force on the septal tissue and closes the aperture.

Tubular patent foramen ovale (PFO) closure device with catch system

The present invention provides a patent foramen ovale (PFO) closure clip. The clips of the present invention include two closure members 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 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 take various forms depending, in part, upon the distribution of force required to close a given PFO. Thus, in some embodiments, the closure members include arcuate peaks. In other embodiments, the closure members include loops. In still other embodiments, the closure members include prongs.

Patent foramen ovale (PFO) closure clips

Devices and methods are disclosed for the delivery of a compressible implant into a bodily lumen. The delivery device includes an enlarged section that is configured to house the implant during delivery thereof into a patient. In certain embodiments, the implant is kept within the delivery device in a substantially uncompressed configuration prior to the delivery thereof.

Implant delivery device

Devices and techniques for modifying and maintaining a configuration of an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices and techniques relate particularly to, but are not limited to, modifying and maintaining a configuration of a PFO occluder made from a polymer tube. The proximal portion of a catch member may be provided with one or more protrusions, or arms, or bump or other raised element for securing the occluder in a partial or fully deployed configuration, either temporarily or permanently.

Catch members for occluder devices

Devices, delivery systems, and delivery techniques for an occlusion device for closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. Specifically, an occluder with a catch member that holds the occluder in the deployed, expanded profile configuration is provided within a delivery sheath. The proximal end of the catch member includes a flap that when positioned proximal to the proximal end of the occluder holds the occluder in the expanded profile configuration. The flap is sized and formed of a material that allows the flap to deform by bending back and forth in axial and radial directions. In certain embodiments, the flap has segments divided by notches. In certain embodiments, deforming the flap in the proximal direction requires a different amount of force than deforming the flap in the distal direction.

Deformable flap catch mechanism for occluder device

The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.

Removable intracardiac RF device

Devices, delivery systems and delivery techniques for an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices, delivery systems and delivery techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube. Specifically, a petal-shaped occluder with a catch system is provided within a delivery sheath. In certain embodiments, the delivery system includes a first securement system for securing a first end of the occluder and a second securement system for securing a second end of the occluder to a delivery catheter and a delivery wire contained in the delivery system. The securement enable the deployment (and retrieval) of the device. The securement systems enable pushing and pulling of respective ends of the occluder to expand and contract the device by varying its axial length. In one aspect, the first securement system employs a threaded connection and the second securement system employs a suture connection. In another aspect, the first securement system employs a threaded connection and the second securement system employs a collet finger connection. The securement systems are detached when the device has been properly positioned. The securement systems can be manipulated by control systems provided in the control portion of the delivery system.

Occluder device double securement system for delivery/recovery of such occluder device

Delivery (and recovery) devices and techniques for delivering an implant into a desired location within the body and catch systems for such implants. The devices and techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube. A catch system maintains an occluder in a deployed configuration by holding it in a reduced axial length position. Some embodiments have a compressible tip. Some embodiments have temporary catching mechanisms.

Catch member for PFO occluder

Devices and methods are disclosed for the delivery of an implant into small bodily spaces. The delivery devices include an expandable portion configured for placement within such bodily spaces and subsequent expansion to facilitate the delivery of the implant.

Implant delivery device with expanding tip

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.

Sterilization devices and methods for deploying porous implants within the fallopian tubes are disclosed. The devices include a catheter component including an external electrode sheath containing at least two deployable implants and a positioning member. Sliding the external sheath proximally disposes the implants within the fallopian tubes, while sliding both the positioning member and external electrode sheath distally reloads a second implant into the external electrode sheath. The devices further includes a handle component, which houses a chassis, external electrode sheath carrier, reciprocating shaft, positioning member carrier and first and second engaging members. The reciprocating shaft may be operated by a motor to slide distally and proximally along a long axis. The reciprocating shaft, external electrode sheath and its carrier, upon selective actuation, move together proportionally to deploy and reload the implants to facilitate occlusion of the fallopian tubes and complete sterilization.

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Boston, MA, United States of America

David J Callaghan