Abstract: An ocular needle guide for access into a space below a sclera of an eye comprises a housing. The housing has a contact surface and a needle guide surface. The contact surface defines a cavity within the housing. The contact surface extends at least partially along a contact plane. The needle guide surface extends about a needle axis to define a needle guide channel. The needle guide channel extends through the housing to an opening defined by the contact surface such that the needle guide channel opens to the cavity via the opening. The needle axis is substantially parallel to the contact plane. The contact surface is shaped such that when the ocular needle guide is positioned on the eye, a portion of the sclera is positioned within the cavity, and a surface of the eye contacts and takes a shape of the contact surface.

Abstract: Systems and methods for delivering fluid within a lumen may be provided. For example, a device can include an elongated tubular structure having a central opening through which fluid may flow. The central opening can be defined by an open proximal end and an open distal end. The elongated tubular structure can have an elastic section toward the open distal end. The device can also include a blocking device such as a balloon within the central opening of the elongated tubular structure that can help or be configured to prevent the flow of fluid through the central opening between the open proximal end and the open distal end. The device can further include a balloon disposed on an outer surface of the elongated tubular structure. The balloon can be affixed to the outer surface of the elongated tubular structure at a proximal and/or distal attachment site.

Abstract: The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form.

Abstract: A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The single disc mechanical closure device is comprise of a distal and proximal anchor constrained by a closure line to facilitate mechanical closure by bringing the distal and proximal anchors into close proximity along the closure line.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form. A transseptal approach may be used to plicate and retain tissue on the atrial side of the mitral valve to achieve a reduction in mitral valve regurgitation.

Abstract: A deflecting guide catheter for use in minimally invasive medical procedures such as the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The catheter includes an elongated tubular portion having various durometers along its length and at least one puller wire attached to an anchor band near the distal end. The deflecting guide catheter is used to provide a means for guiding a plication device or other medical instrument into a desired position within the vasculature or heart chambers of a patient.

Abstract: A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The single disc mechanical closure device is comprise of a distal and proximal anchor constrained by a closure line to facilitate mechanical closure by bringing the distal and proximal anchors into close proximity along the closure line.

Abstract: A deflecting guide catheter for use in minimally invasive medical procedures such as the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The catheter includes an elongated tubular portion having various durometers along its length and at least one puller wire attached to an anchor band near the distal end. The deflecting guide catheter is used to provide a means for guiding a plication device or other medical instrument into a desired position within the vasculature or heart chambers of a patient.

Abstract: A system for using a helical retainer in the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a preferably prolapsable crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in at or near the subvalvular region of the mitral valve annulus. Fourth, a helical retainer clip deployed by the plication device in order to retain the plicated tissue in the plicated form. Alternatively, the fourth device is a retainer delivery catheter that enables delivery of a helical retainer over the outside of the plication device.

Abstract: A system for using a barbed tubular retainer in the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make placations in the subvalvular region of the mitral valve annulus. Fourth, a barbed tubular retainer deployed by the plication device in order to retain the plicated tissue in the plicated form. Alternatively, the fourth device is a retainer delivery catheter that enables delivery of a barbed tubular retainer that is attached to its distal end over the outside of the plication device.

Abstract: A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form. A transseptal approach may be used to plicate and retain tissue on the atrial side of the mitral valve to achieve a reduction in mitral valve regurgitation.

Abstract: A steerable guidewire having a deflectable distal tip which comprises a longitudinal hypotube and an interlocking spring coil attached to the distal end of the hypotube and also includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining ribbon which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip. The distal end of the deflection member has “skived,” or tapered, sides to enhance the flexibility of the guidewire.

Abstract: A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The single disc mechanical closure device is comprise of a distal and proximal anchor constrained by a closure line to facilitate mechanical closure by bringing the distal and proximal anchors into close proximity along the closure line.

Abstract: A device and method for deploying a mechanical closure device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The single disc mechanical closure device is comprise of a distal and proximal anchor constrained by a closure line to facilitate mechanical closure by bringing the distal and proximal anchors into close proximity along the closure line.

Abstract: The present invention is a method and device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway.

Abstract: A steerable guidewire having a deflectable distal tip which comprises a longitudinal hypotube and an interlocking spring coil attached to the distal end of the hypotube and also includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining ribbon which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip. The distal end of the deflection member has “skived,” or tapered, sides to enhance the flexibility of the guidewire.

Abstract: The present invention relates to a delivery system for delivering a device for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart. The delivery system has an elongate member having a proximal and distal end. A deflectable needle assembly having luminal and abluminal surfaces is slideably engaged within the elongate member. An actuator is slideabley engaged within the elongate member and attached to the needle tip assembly such that translational movement of the actuator causes deflection of the deflectable needle assembly.