Abstract: The invention provides a manufacturing method for processing polymeric microspheres which are suspended in a liquid. The invention also provides polymeric microspheres produced by the method which can be used in medical settings as tissue fillers, tissue bulking agents, embolization agents, and/or as drug delivery agents.

Abstract: The proximal actuator is operable with various medical devices which have one tube or wire axially movable with respect to another tube or wire (e.g., a guide wire operable within an actuation sleeve). The actuator includes a deployment handle which is transversely or laterally (not axially) removably attachable. The actuator includes first retaining device (e.g., spring clip grip) removably attachable to the actuation sleeve and second retaining device removably attachable to the wire member. The second retainer moves relative to the first retainer such that the sleeve slides over the wire thereby moving a medical device at the distal end of the system. The handle may have a grip and a sleeve defining an aperture and a sliding member in the sleeve. The slide member is rotatably mounted to one retainer and is threadably mounted to the other retainer such that upon rotation, one moves with respect to the other.

Abstract: The radially expandable frame utilized during catheterization includes a guide wire, a radiopaque radially expandable frame with distal and proximal frame ends wherein the guide wire freely passes through the proximal frame end, an elongated actuation sleeve having a flexible distal end piece (coil strain relief) through which freely passes the guide wire, and a friction locking mechanism located at the proximal end of the system which is defined by the proximal ends of the actuation sleeve and guide wire. The expandable frame includes radiopaque frame struts and has a closed, radially compact form and an open, radially expanded form. The actuator flexible end piece is a coil which enables the system to flex in excess of 90 degrees. The actuator sleeve, at its proximal end, includes a friction locking mechanism having locking members with respective locking surfaces.

Abstract: The proximal actuator is operable with various medical devices which have one tube or wire axially movable with respect to another tube or wire (e.g., a guide wire operable within an actuation sleeve). The actuator includes a deployment handle which is transversely or laterally (not axially) removably attachable. The actuator includes first retaining device (e.g., spring clip grip) removably attachable to the actuation sleeve and second retaining device removably attachable to the wire member. The second retainer moves relative to the first retainer such that the sleeve slides over the wire thereby moving a medical device at the distal end of the system. The handle may have a grip and a sleeve defining an aperture and a sliding member in the sleeve. The slide member is rotatably mounted to one retainer and is threadably mounted to the other retainer such that upon rotation, one moves with respect to the other.

Abstract: The controllable deployment system for a radially expandable frame utilized during catheterization includes a guide wire, a radially expandable frame through which the guide wire passes, an elongated actuation sleeve over the guide wire, and a proximal locking mechanism. The expandable frame has a closed, radially compact form and an open, radially expanded form. The proximal end of the frame is coupled to an actuator sleeve. The actuator sleeve, at its proximal end, includes a friction locking mechanism having locking members with respective locking surfaces. The locking mechanism permits the user to lock or hold static the actuator sleeve (and therefore, the expandable frame) with respect to the guide wire, typically in an open, radially expanded form and a closed form. Tactile markers or indicia may be included.

Abstract: The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture's terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle.

Abstract: The self securing suture includes a suture having a stiff end segment at a terminal end and a toggle disposed on the terminal end such that the stiff end segment and toggle define an acute angle between 25 degrees and 65 degrees. The toggle may be a metal or a biocompatible plastic. In one embodiment, a portion of the stiffened end segment is swaged onto the toggle in a closed channel. The present invention also includes methods for producing suture toggles. One method includes creating a partial channel on a toggle, stiffening an end segment of a suture thread, positioning a portion of the stiffened end segment in the partial channel, and swaging the toggle channel closed. The toggle and swaged suture thread may be coated with a biocompatible polymer. An alternative method of manufacture includes utilizing a tubular toggle, passing the stiffened end segment through the tube and swaging the toggle tube closed.

Abstract: The controllable deployment system for a radially expandable frame utilized during catheterization includes a guide wire with a stop, a radially expandable frame through which the guide wire freely passes, an elongated actuation sleeve over the guide wire, and a friction locking mechanism located at the proximal end of the system. The expandable frame has a closed, radially compact form and an open, radially expanded form. The proximal end of the frame is coupled to an actuator sleeve. The actuator sleeve, at its proximal end, includes a friction locking mechanism having locking members with respective locking surfaces. The locking mechanism permits the user to lock or hold static the actuator sleeve (and therefore, the expandable frame) with respect to the guide wire, typically in an open, radially expanded form and a closed form. Tactile markers or indicia may be included.

Abstract: The suture delivery system utilizes two sutures. Each suture has a filament body and a toggle bar. The delivery system includes an elongated central tube with two needle retainer guides and a cam distally disposed on the central tube. The needles have piercing needle ends and each needle end carries a respective toggle bar for a suture disposed thereon. A longitudinally movable member is coupled to the needles. The needles are movably disposed in respective needle retainer guides. An actuator is coupled to the movable member such that when the actuator moves, the needles extend outward such that the needle ends move over the cam. In a further embodiment, the actuator includes a first user actuation surface coupled to the movable member and the central tube includes a second user actuation surface which is generally static. In a further embodiment, a locking member is disposed on the second user actuation surface. The cam may take one of a variety of shapes.

Abstract: An expandable tubular reinforcing member used for a body lumen that is made from a pair of end sections each constituted of an endless element of sinuous configuration defining a plurality of U-bends, an elongated element of sinuous configuration defining a plurality of U-bends extending between the end sections and spaced therefrom and being disposed in a helical configuration of the same diameter as the end sections. Turns of the helix of the elongate element are spaced apart with the U-bends of the elongated element aligned with the U-bends of the end sections. A plurality of first interconnecting strips, each having a bend, spans the space between axially successive turns of the elongated element and interconnects axially aligned proximate U-bends of the elongated element to define cells bounded by the elongated element and circumferentially successive first interconnecting strips.

Abstract: The filter device captures embolic material in a blood vessel and is placed in the blood vessel via a guide wire. The guide wire has a proximal end, a distal end and a stop near its distal end. The filter device includes an expandable frame of frame struts having a closed, radially compact form and an open, radially expanded form. The frame, in the radially expanded form, has frame struts forming a pair of facing frustoconical frame structures. Filter material is attached to one of the pair of frustoconical frame structures. In one embodiment, the filter material is a perforated membrane. The guide wire extends through the expandable frame and the expandable frame is freely movable over the guide wire (likewise, the guide wire is freely movable within the frame), both rotatably and longitudinally, except distally beyond the stop near the distal end of the guide wire.

Abstract: The self securing suture includes a suture having a stiff end segment at a terminal end and a toggle disposed on the terminal end such that the stiff end segment and toggle define an acute angle between 25 degrees and 65 degrees. The toggle may be a metal or a biocompatible plastic. In one embodiment, a portion of the stiffened end segment is swaged onto the toggle in a closed channel. The present invention also includes methods for producing suture toggles. One method includes creating a partial channel on a toggle, stiffening an end segment of a suture thread, positioning a portion of the stiffened end segment in the partial channel, and swaging the toggle channel closed. The toggle and swaged suture thread may be coated with a biocompatible polymer. An alternative method of manufacture includes utilizing a tubular toggle, passing the stiffened end segment through the tube and swaging the toggle tube closed.

Abstract: The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture's terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle.

Abstract: The vascular protection and embolic material retrieval device is used in connection with a guidewire and a catheter sheath during catheter based procedures. The device includes a discontinuous loop of memory sheath material having an open loop shape when the loop is not radially restrained in the catheter sheath. When the loop is disposed beyond the distal end of the catheter sheath, the loop is deployed and forms a discontinuous loop due to the memory characteristic of the loop material. The device includes a lead line having a proximal end attached to the guidewire and a distal end attached to the discontinuous loop. A substantially conical filter adapted to capture embolic material has an open conical end attached to the discontinuous loop and a conical end point attached to the guidewire. When the loop is disposed outboard of the catheter sheath, the filter unfurls forming a conical filter trap for embolic material.

Abstract: The filter device captures embolic material in a blood vessel and is placed in the blood vessel via a guide wire. The guide wire has a proximal end, a distal end and a stop near its distal end. The filter device includes an expandable frame of frame struts having a closed, radially compact form and an open, radially expanded form. The frame, in the radially expanded form, has frame struts forming a pair of facing frustoconical frame structures. Filter material is attached to one of the pair of frustoconical frame structures. In one embodiment, the filter material is a perforated membrane. The guide wire extends through the expandable frame and the expandable frame is freely movable over the guide wire (likewise, the guide wire is freely movable within the frame), both rotatably and longitudinally, except distally beyond the stop near the distal end of the guide wire.

Abstract: The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture's terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle.

Abstract: The self securing suture includes a suture having at least one terminal end and a toggle, formed of suture material, at the suture's terminal end. In one embodiment, the suture toggle is a bar. In another embodiment the suture is a wire and the toggle is a wire element toggle. The wire element toggle is a double strand segment or an open loop segment. The suture delivery system includes a slotted needle configured such that a protruding tab or leg of the toggle bar fits within slot of the needle. For wire sutures, the open loop wire element toggle fits within the slotted needle. In another embodiment, a depending wire tip, from the wire element toggle, fits within the slot in the needle.