Abstract: An embolic protection apparatus having a deflector tube and two expanders each having a plurality of circumferentially spaced, longitudinally oriented fingers. The fingers of each expander have radially constrained ends and radially expandable ends aligned opposite the fingers of the other expander. The deflector tube is disposed within one of the expanders that also has a flexible sleeve covering at least the fingers of the expander. The deflector and the expanders are engageable with each other using compound leverage to transform the apparatus between a collapsed configuration and an expanded configuration wherein the fingers of the covered expander are radially splayed to dilate the sleeve. Also disclosed are a catheter having the protection apparatus and a method of using the catheter.

Abstract: An intravascular, distal protection device including a braided mesh that may be selectively transformed between a collapsed configuration, a filter configuration and an occlusive configuration by mechanical or thermal operation. Alternatively, the distal protection device may include a non-inflatable occlusion valve located within the mesh and actuated by the same mechanical operation that transforms the braided mesh.

Abstract: An occluder catheter having an outer tube, an inner shaft extending slidably through the outer tube, and two expanders attached, respectively, to the distal ends of the inner shaft and the outer tube. The expanders each have a plurality of circumferentially spaced, longitudinally oriented fingers. The fingers each have radially expandable ends and radially constrained ends and the fingers of each expander are interposed with the fingers of the other expander. A flexible non-porous sleeve covers at least the fingers of both expanders. By moving the outer tube with respect to the inner shaft, the occluder is transformable between a collapsed configuration and an expanded configuration wherein the fingers of at least one of the expanders are radially splayed to dilate the sleeve. One embodiment of the invention incorporates a single expander having circumferentially juxtaposed fingers, the expander being mated with a deflector ring.

Abstract: A surgical fastener for use in surgical procedures comprises a first member, a second member, and an anchor. Surgical materials may be secured within the surgical fastener. Methods of securing the surgical fastener to an anatomical structure are disclosed herein.

Abstract: A surgical fastener for use in surgical procedures comprises a first member, a second member, and an anchor. Surgical materials may be secured within the surgical fastener. Methods of securing the surgical fastener to an anatomical structure are disclosed herein.

Abstract: A catheter for use in a body lumen including a guidewire shaft having a guidewire shaft sectional portion. The guidewire shaft sectional portion is disposed along a proximal and/or distal portion of an elongate catheter shaft for holding a guidewire in place thereon. The guidewire shaft sectional portion includes at least two clips or segments along the catheter shaft that are separated by a gap. The clips hold the guidewire in place along the catheter, and the gap between adjacent clips allows a clinician ready access to the guidewire.

Abstract: Manual bone anchor placement devices include a lever, a force translator and a rotary force mechanism. The devices are substantially gun- or pistol-shaped and are actuated when a user squeezes the lever to the gripping portion of a handle. Manual, linear force on the lever is mechanically translated through the force translator to the rotary force mechanism which transmits a rotary force to a securing element, or coupler, which mates with a bone anchor screw. The rotation of the securing element or coupler applies a torque on the bone anchor screw thereby placing the screw into bone. Kits comprising any of: a molded flexible sleeve for enclosing a suture, a retaining clip for preventing the suture from slipping out of the sleeve, a buttress-shaped bone anchor screw comprising a micropolished eyelet for receiving a suture, and a suture which may, or may not be pre-attached to the bone anchor screw, are disclosed. A collapsible, protective cover for a bone anchor screw is also disclosed.

Abstract: Methods and apparatus are provided for moving an intraluminal filament, such as a shaft or hypotube. The actuator includes a housing having a channel therein, the channel having at least a first inclined surface. The actuator also includes a pivotable actuator assembly coupled to the housing and having first and second spaced-apart jaws extending into the channel. The first and second jaws define an opening of a first dimension therebetween. The actuator assembly pivots for urging at least one of the first and second jaws against at least the first inclined surface to transition the first dimension to a second dimension. The method comprises aligning the intraluminal filament between spaced-apart jaws of a pivotable actuator assembly, pivoting the actuator assembly to urge said jaws against at least one surface causing said jaws to grip the intraluminal filament, and further pivoting the actuator assembly to move the intraluminal filament.

Abstract: A system for treating a vascular condition, including a hollow guidewire having a central lumen, a core wire received in the central lumen of the hollow guidewire and partially extended from a proximal end of the hollow guidewire, an inflatable balloon attached proximate a distal end of the hollow guidewire, a detachable inflation adaptor, and a clamping device. The inflation adaptor includes an axial insertion block having a funnel-shaped receiver to guide the extended core wire into the axial insertion block. The clamping device is axially aligned with the receiver. The extended core wire and the hollow guidewire are translated relative to each other to control a flow of inflation fluid into the inflatable balloon while the clamping device is in a clamped position. An inflation adaptor and a method of operation are also disclosed.

Abstract: A system for treating a vascular condition, including a hollow guidewire having a central lumen and an inflation hole formed in a sidewall of the hollow guidewire, an occlusion balloon attached proximate to a distal end of the hollow guidewire, and a frictional valve. The frictional valve includes a portion of a core wire positioned within a proximal end of the hollow guidewire, a valve plug attached to the core wire, and at least one frictional plug attached to the core wire proximal to the valve plug. Flow of fluid through the central lumen of the hollow guidewire is controlled by axial translation of the core wire to position the valve plug with respect to the inflation hole, while the frictional plug provides a tailored valve compliance characteristic.

Abstract: A bone anchor placement device includes a handle and a shaft extending in a distal direction from the handle. A head is disposed at a distal end of the shaft and a retractable anchor driver is disposed within the head. The recessed anchor mount is operable to advance from the head during placement of an anchor in to a supporting structure. The recessed anchor mount is operable to retract into the head during insertion of the placement device within a human body. The recessed anchor mount may include a push wire for advancing and retracting the retractable anchor mount.

Abstract: The present invention relates to suture spacers and methods for their use. More particularly, the present invention relates to devices which permit a surgeon to create a consistent amount of suture slack in a suture line when tying sutures under very tight space constraints including procedures such as bladder neck stabilization and treatment of hypermobility or intrinsic sphincter deficiency. Further, the present invention relates to methods of tying sutures using the disclosed devices in such procedures.

Abstract: Manual bone anchor placement devices include a lever, a force translator and a rotary force mechanism. The devices are substantially gun- or pistol-shaped and are actuated when a user squeezes the lever to the gripping portion of a handle. Manual, linear force on the lever is mechanically translated through the force translator to the rotary force mechanism which transmits a rotary force to a securing element, or coupler, which mates with a bone anchor screw. The rotation of the securing element or coupler applies a torque on the bone anchor screw thereby placing the screw into bone. Kits comprising any of: a molded flexible sleeve for enclosing a suture, a retaining clip for preventing the suture from slipping out of the sleeve, a buttress-shaped bone anchor screw comprising a micropolished eyelet for receiving a suture, and a suture which may, or may not be pre-attached to the bone anchor screw, are disclosed. A collapsible, protective cover for a bone anchor screw is also disclosed.

Abstract: Low profile, bioabsorbable, bone anchor protective covers are disclosed for isolating bone anchors to reduce accidents with the sharp bone anchor tip and/or edges before it is inserted into a target site. Protective covers with antimicrobial material to reduce contamination of the target site by insertion of the bone anchor therethrough are also disclosed herein. The protective covers of the present invention are adapted to reduce accidents, for example, puncture of a doctor's glove, abrasion of the patient's tissue or insertion of the bone anchor tip into tissue other than the target tissue.

Abstract: Manual bone anchor placement devices include a lever, a force translator and a rotary force mechanism. The devices are substantially gun- or pistol-shaped and are actuated when a user squeezes the lever to the gripping portion of a handle. Manual, linear force on the lever is mechanically translated through the force translator to the rotary force mechanism, which transmits a rotary force to a securing element, or coupler, which mates with a bone anchor screw. The rotation of the securing element or coupler applies a torque on the bone anchor screw thereby placing the screw into the bone. A collapsible, protective cover for a bone anchor screw is also disclosed.

Abstract: A surgical fastener for use in surgical procedures comprises a first member, a second member, and an anchor. Surgical materials may be secured within the surgical fastener. Methods of securing the surgical fastener to an anatomical structure are disclosed herein.

Abstract: A surgical instrument for applying sutures to tissue includes a needle deployment mechanism and a catch mechanism. In some embodiments, the needle deployment mechanism employs a linear path. Alternatively, it can employ a curved needle. The surgical instrument may include a rotatable head, a bend, and/or a malleable elongated body member formable into various shapes.

Abstract: The present invention relates to suture spacers and methods for their use. More particularly, the present invention relates to devices which permit a surgeon to create a consistent amount of suture slack in a suture line when tying sutures under very tight space constraints including procedures such as bladder neck stabilization and treatment of hypermobility or intrinsic sphincter deficiency. Further, the present invention relates to methods of tying sutures using the disclosed devices in such procedures.

Abstract: Manual bone anchor placement devices include a lever, a force translator and a rotary force mechanism. The devices are substantially gun- or pistol-shaped and are actuated when a user squeezes the lever to the gripping portion of a handle. Manual, linear force on the lever is mechanically translated through the force translator to the rotary force mechanism which transmits a rotary force to a securing element, or coupler, which mates with a bone anchor screw. The rotation of the securing element or coupler applies a torque on the bone anchor screw thereby placing the screw into bone. Kits comprising any of: a molded flexible sleeve for enclosing a suture, a retaining clip for preventing the suture from slipping out of the sleeve, a buttress-shaped bone anchor screw comprising a micropolished eyelet for receiving a suture, and a suture which may, or may not be pre-attached to the bone anchor screw, are disclosed. A collapsible, protective cover for a bone anchor screw is also disclosed.

Abstract: A bone anchor placement device includes a handle and a shaft extending in a distal direction from the handle. A head is disposed at a distal end of the shaft and a retractable anchor driver is disposed within the head. The recessed anchor mount is operable to advance from the head during placement of an anchor in to a supporting structure. The recessed anchor mount is operable to retract into the head during insertion of the placement device within a human body. The recessed anchor mount may include a push wire for advancing and retracting the retractable anchor mount.