Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a medical instrument (such as a catheter or the like) and secures the instrument in place relative to a skin penetration point. In some circumstances, the anchor device may allow the anchor device to be used after medical instrument is already in place without the need for a second penetration point for the anchor device.

Abstract: This disclosure contains methods, devices, and systems for object removal from a body, including removal of a stent from a body. Methods of the present disclosure include inflating a balloon on a catheter, engaging a stent with a socket defined by a surface of the balloon, the surface inwardly sloped toward a lumen of the catheter, and retracting a portion of the stent through the socket and into the lumen. The present disclosure also includes methods for making a catheter, including forming a balloon, inverting a portion of the balloon, and attaching the balloon to a catheter such that a surface of the balloon defines a socket that is inwardly sloped toward a lumen of the catheter.

Abstract: Methods and apparatus for providing percutaneous access to the presacral space in a minimally invasive, low trauma, manner. A number of related methods and surgical tool sets form a percutaneous pathway from an incision through the patient's skin adjacent to the coccyx and inserting an elongated guide assembly through the incision to locate the guide assembly against the anterior surface of the sacrum to access a presacral target point. The provision of the percutaneous pathway described herein allows for the introduction of therapeutic devices or media, diagnostic instruments, and/or drug delivery to the presacral space.

Abstract: A stent delivery catheter for rapid exchange carries at its distal end a sleeve (12) to surround a self-expanding stent (10) and a tension wire (30) running the length of the catheter to release the stent by proximal withdrawal of the sleeve. A tubular catheter shaft (62) surrounds the tension wire. An inner catheter (44) defines a guidewire lumen (48) with a proximal guidewire exit part (58) at the distal end of the catheter shaft. The inner catheter carries an abutment (32) to restrain the stent from moving proximally when the sleeve is pulled proximally. There is a gap (74) between the abluminal surface of the inner catheter and the luminal surface of the catheter shaft, in which the tension wire is accommodated.

Abstract: An introduction device for introducing an object into a vessel of a body comprises a tubular channel (15) and a dilator (11) carrying the channel. To keep the diameter of the body canal as small as possible, the wall thickness of the channel (15) is max. 0.06 mm. The channel (15) is made of a hard plastic material, such as polyamide or polyester, such that the channel (15) is not deformed by compression when the device is advanced in the body and the dilator (11) is retracted. Further, a tight fit on the dilator also prevents such compressions.

Abstract: There is disclosed an insertion device comprising an insertion needle holder and a drive mechanism for linearly moving the insertion needle holder in a puncturing direction. The insertion needle holder also includes at least one actuating element for actuating a drive mechanism. The drive mechanism converts a driving motion of the actuating element, which extends transversely or opposite to the puncturing direction, into a puncturing motion of the insertion needle holder.

Abstract: Disclosed herein is a medical wire with an intracorporeally indwelling member connected to the leading end part of a conductive wire body through a thermally-fusible connecting member, wherein expected heat generation can be achieved even when a conductive member that causes leak comes into contact with the leading end part of the conductive wire body, and thus the intracorporeally indwelling member can be surely released.

Abstract: An inner catheter (36) for use in an endoluminal delivery assembly (10) includes a stiffening element positioned at a transition between a hypotube (36a), a middle tube (36b) and a distal tube (36c) of the inner catheter (36) having different flexibilities. The stiffening element comprises three stiffening wires (42) embedded within the internal wall of the inner catheter (36) at their proximal ends. The stiffening wires (42) extend inwardly and distally to meet at an apex (60).

Abstract: An insertion device for safely creating an incision through tissue is provided. The device includes a tubular member and a cutting assembly. The tubular member includes proximal and distal ends and defines a passageway therethrough. The tubular member includes at least one longitudinal slot extending proximally from a distal end thereof. The cutting assembly includes a blade assembly mounted on a distal end thereof. The distal end of the cutting assembly is configured for sliding reception within the passageway of the tubular member. The blade assembly includes at least one blade movable between a retracted position and an extended position. The blade assembly is configured such that the at least one blade is received through the at least one longitudinal slot of the tubular member when the at least one blade is in an extended position.

Abstract: A method of implanting a cardiac prosthesis is disclosed. The method can include placing a cardiac prosthesis into an elongated barrel of an implanter, the barrel comprising an open discharge end. An introducer apparatus is attached onto the open discharge end of the barrel, the introducer apparatus comprising a sidewall portion that extends from a first end portion and terminates in a distal end portion that gradually tapers to cross-sectional dimension that is less than cross-sectional dimension at the first end portion. The introducer apparatus can be configured to permit movement of the barrel, including the discharge end, axially through and beyond the distal end portion of the introducer apparatus. An opening can be created in tissue that provides a path from the opening to an implantation site. The introducer apparatus is inserted into the opening and the barrel axially can be moved through the introducer apparatus to position the discharge end of the barrel near the implantation site.

Abstract: A machine and process useful for processing a delicate workpiece, e.g., an implantable medical device, includes a carrier having a mandrel and wheels. The workpiece is positioned on the mandrel, which is free to roll by gravity on rails which cooperate with the wheels to self-align the travel of the carrier. The carrier can move the workpieces through a series of processing steps by gravity feed and without human intervention. A laterally movable carriage receives the rolling carriers and moves the carrier for processing, and returns the carrier to the rails to again roll by gravity to another processing substation for additional processing. An elevator, which can including processing units itself, is positioned along the rails to receive carriers and raise them so they can continue to roll for further processing.

Abstract: A catheter assembly comprises a catheter having a catheter shaft with a first rotatable sheath rotatably disposed thereabout. A first guidewire housing which defines a first guidewire lumen for passage of a first guidewire therethrough is engaged to the first rotatable sheath. A first stent, which when in the reduced stent state, is disposed about at least a portion of the first rotatable sheath. A second stent, which when in the reduced stent state, is positioned adjacent to the first stent.

Abstract: A gripping device for a catheter assembly is disclosed providing enhanced gripping power for the operator of the catheter assembly. The gripping device is situated at the proximal portion of the catheter assembly and the proximal terminus of an external catheter sheath is attached near or to the body of the gripping device.

Abstract: Coil assemblies and related components and methods are disclosed. The coil assemblies can include two or more embolic coils having one or more different coil parameters.

Abstract: A method for arthroscopically accessing a region of a joint, wherein the joint has a capsule disposed intermediate at least one layer of outer tissue and the joint, the method comprising: arthroscopically positioning visualization apparatus adjacent to an exterior surface of the capsule; and while visualizing the exterior surface of the capsule, arthroscopically forming an opening through the capsule.

Abstract: A braided sleeve device having a tubular body that is symmetrically disposed around an imaginary longitudinal axis. The tubular body has a first end, a second end and a flange transition point that is located proximate the second end. The tubular body is comprised of interwoven strands that extend from the first end to the second end. The tubular body has a first diameter from the first end to the flange transition point. The tubular body also has a diameter that increases in size from the flange transition point to the second end, therein forming a flare. The flare causes the interwoven stands of the braided sleeve to be reoriented into a perpendicular with the longitudinal axis. A reinforcement ring is bonded to the braided sleeve proximate its second end. The reinforcement ring retains the flare in the configuration of the braided sleeve.

Abstract: The stent placement dilation balloon assembly comprises a catheter having a distal end, a distal end portion, and a proximal end, a balloon mounted to, about, and around the distal end portion of the catheter. The assembly further includes an elastic sheath positioned about and around the balloon. The outer surface of the sheath includes a profile which encourages stent securement. A stent is mounted on the sleeve for placement in a vessel in a human body.

Abstract: An introducer system for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus is comprised of a flexible, elongate, outer elongate element having a first shape or bias along a portion. The first shape on the outer element may be prebiased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal portion. The inner elongate element is telescopically disposed in the outer sheath.

Abstract: Embodiments of a drive shaft collet adapted for linking a surgical drive shaft to a surgical instrument so that the instrument may be driven by the drive shaft are disclosed. The collet includes a helically-swept cutout which forces a received shaft to be rotated into alignment during insertion. Collectively, the drive shaft collet and shaft are designed to avoid the need for multiple attempts at inserting the shaft into the collet in order to align the flats on the shaft with the flats on the collet.

Abstract: Apparatus and methods are provided for providing access to a body lumen, e.g., to deliver a pacing lead within a patient's heart. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending therebetween. An elongate member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the elongate member, the sheath being expandable from a contracted condition to facilitate insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. A stylet or other shaped element is insertable into the elongate member for changing a shape of at least a distal tip of the elongate member, e.g., for accessing side branches extending from a body lumen, e.g., within a patient's coronary venous system.

Abstract: The present invention provides a multiple port infusion introducer including an introducer sheath having a tubular introducer wall defining an introducer lumen formed therethrough. The introducer wall includes a proximal portion extending to a distal portion along a longitudinal axis. A plurality of ports is positioned proximate the proximal end of the introducer sheath. Each port has a tubular port wall defining a port lumen formed therethrough. Each port lumen is in fluid communication with the introducer lumen. Each port wall has a proximal end extending to a distal end along a central axis. A delivery member is disposed through the proximal end of one of the ports and extends through the port lumen and into the introducer lumen proximate the proximal end of the introducer sheath.

Abstract: Embolic protection filtering devices and methods of making and using the same. The present invention may include an embolic protection filtering device including a filter cartridge that is slidable over medical devices, for example, guidewires. The filter cartridge may have a filter coupled thereto and may have desirable flexibility and trackability characteristics.

Abstract: Segmented articulatable stent of open structure comprised of end-connected struts of first and second lengths making up first and second segments with angular interconnects between adjacent first and second segments.

Abstract: An insertion device for infusion sets, including a housing for generally enclosing an infusion set placed in the insertion device and a drive device for displacing the infusion set, wherein the displacing is as friction-free as possible with respect to the housing.

Abstract: Various embodiments of methods and apparatus for treating defective heart valve are disclosed herein. In one exemplary embodiment, a transcatheter heart valve is disclosed that includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

Abstract: A medical instrument positioning device that allows medical personnel to quickly and easily insert and remove medical instruments and accessories through a portal in a patient is described. The device guides the inserted instruments directly to the surgical site so that the surgeon does not have to search to reacquire the site. The device is generally “L” shaped, having a handle on the proximal end and a somewhat sharpened tip on the distal end. The body of the device is generally curved or otherwise shaped to form a channel down which medical instruments, cameras, accessories, etc. can be positioned. The tip of the device is shaped so as to be easily inserted into a portal. Once inserted, the device is positioned so that the distal end is in proximity to a surgical site.

Abstract: A method of removing an implanted vessel filter by a femoral approach comprising the steps of providing a catheter with a curved tip, inserting a straightening device into the catheter to move the catheter tip from a curved position to a more straightened position, advancing the catheter tip through the femoral vein and past a cranial end of the filter, withdrawing the straightening device to enable the catheter tip to return to the curved condition, and inserting a filter grasping device though the catheter and a curved catheter tip to exit a distal portion to grasp the filter.

Abstract: A system and method is provided for using a first vascular image, or more particularly a plurality of control points located thereon, to identify a border on a second vascular image. Embodiments of the present invention operate in accordance with an intra-vascular ultrasound (IVUS) device and a computing device electrically connected thereto. Specifically, in one embodiment of the present invention, an IVUS console is electrically connected to a computing device and adapted to acquire IVUS data. The IVUS data (or multiple sets thereof) is then provided to (or acquired by) the computing device. In one embodiment of the present invention, the computing device includes a plurality of applications operating thereon—i.e., a border-detection application, an extrapolation application, and an active-contour application. These applications are used to (i) identify a border and control points on a first IVUS image (i.e., any IVUS image), (ii) extrapolate the control points to a second IVUS image (i.e.

Abstract: The apparatus for deployment of a therapeutic device such as a micro-coil detachably mounts the therapeutic device to a distal portion of a pusher member. In one embodiment, the therapeutic device is detachably mounted to the distal portion of the pusher member by a tubular collar that can be heated by a heater such as an electrical resistance coil to expand the collar and release and deploy the therapeutic device. The apparatus for deployment of a therapeutic device such as a micro-coil may also provide for a pusher member and a connector fiber for securing the therapeutic device to the pusher member. The connector fiber passes through a heater within the distal portion of the pusher member, for heating and breaking the connector fiber to release the therapeutic device when a desired placement of the therapeutic device within the vasculature is achieved.

Abstract: A rotatable connection between a tubular member and an elongate wire of a catheter for allowing rotational movement of the tubular member relative to the elongate wire. The rotatable connection includes a first tube secured to the tubular member and a second tube secured to the elongate wire. The second tube is disposed around the first tube and rotatable relative to the first tube. The longitudinal axis of the tubular member is offset from the longitudinal axis of the elongate wire to allow a guidewire to extend through the tubular member and along the side of the elongate wire.

Abstract: Disclosed is an introducer apparatus comprising an sleeve fixation mechanism or introducer member, such as a catheter, introducer, or ring-like structure, which is attached to a protective sleeve comprising a thin flexible material such a polymeric film. The sleeve is inverted into the passageway of a second member, such as a catheter, feeding tube, introducer, etc., that is advanced through the passageway of the introducer member and is introduced into a bodily passage of a patient, such as the bile duct, nasal passages, colon, etc. The sleeve everts from the passageway of the second member during its advancement to lay down a friction-reducing surface. The sleeve prevents frictional contact between the second member and delicate or sensitive tissues.

Abstract: A method and apparatus for introducing a first elongate medical device and short wire guide that are coupled together into a work site and remotely disconnecting them within the work site such that a secondary device comprising a catheter member can be introduced over the wire guide to the work site, and/or a second wire guide can be introduced to the work site via a passageway of the primary access device. A separating member may be provided to remotely separate the wire guide from the elongate medical device. In one example of the method, a wire guide and primary access device (e.g., a sphincterotome) is coupled to the wire guide and introduced via a duodenoscope into the biliary system.

Abstract: An apparatus for use in fascial cleft surgery adapted to perform blunt dissection between two layers of anatomically named fascia. The dissection performed by the apparatus extends to the limits of anatomic space defined by fusion of said two layers of fascia in a minimally invasive manner. The apparatus is formed of a hollow tube body member including a malleable introducing flange having a spoonbill-like shape. Further, the apparatus includes an elastic dissection balloon movably positioned within the applicator. The dissection balloon is reversibly expandable between a deflated condition and an expanded condition and is movable from a first storage position within the hollow tube body of the applicator to a position exterior thereof.

Abstract: Medical device delivery systems, as well as related methods and components, are disclosed.

Abstract: A method and system for inserting a chest tube through the chest wall of a patient into the pleural cavity. An inserter comprises an elongated tubular member and an inflatable balloon positioned at a distal end of the tubular member. A chest tube has a bore extending therethrough, and is sized such that the inserter is receivable in the chest tube bore. The chest tube and inserter are aligned such that the balloon extends distal of the chest tube when the inserter is received in the chest tube bore. An opening is formed through the chest wall to the pleural cavity, and the inserter is advanced into the chest wall opening such that the balloon is positioned across the opening in an uninflated condition. The balloon is inflated to dilate the opening, and the chest tube is advanced into the dilated opening such that the distal end of the chest tube extends through the opening into the pleural cavity.

Abstract: The inventive sinus tube provide a non-surgical approach to sinus disease. The tube once inserted in the ostia of a paranasal sinus provides the proper aeration and drainage of the sinus cavity. The tube stops the cycle of inflammation, stasis, infection, and continued inflammation associated with sinus disease. The tubes are inserted into the natural ostia of a patient or are inserted after a surgical procedure to enlarge the ostia. The invention also provides an instrument for inserting the inventive tube, methods of using the tube, and kits including the tubes.

Abstract: Methods implant one or more fastening structure(s) in a targeted body region, e.g., within a hollow body organ or an intraluminal space. The fastening structure(s) are implanted to a vessel wall, and serve to secure a prosthesis within the hollow body organ or intraluminal space.

Abstract: A laparoscopic medical fluid delivery device includes a catheter having an articulating tip formed with shape memory properties and thus having a pre-shaped curvature. A tubular member is reciprocatingly slidable axially on the catheter to selectively cover and uncover portions of the articulating tip to thereby selectively vary the degree of curvature of the articulating tip. An actuator operatively linked to the tubular member selectively moves the tubular member reciprocatingly on the catheter. The pre-shaped articulating tip of the catheter is constrained by the tubular member from articulating to the pre-shaped curvature when the tubular member covers the articulating tip, and bends to a selected degree of curvature when the articulating tip is at least partially uncovered by the tubular member.

Abstract: The present invention provides for a method and apparatus to provide hemostasis at a puncture site having a communication tube with a lumen, a top and a bottom; a hemostatic material positioned around the communication tube bottom, the hemostatic material having a first end and a second end; and a hemostatic material cover positioned around the hemostatic material and the communication tube bottom, wherein the hemostatic material cover forms a hollow distal tip cavity at the hemostatic material first end.

Abstract: An apparatus is provided in one example embodiment and includes a body section having an upper surface, a lower surface, and an inner edge circumferentially arranged around at least a portion of an open area. The apparatus also includes a tool extending from the body section into the open area for holding a graft vessel. The lower surface of the body section opposes a receiving vessel when the tool is positioned to transfer the graft vessel to the receiving vessel, such that the graft vessel is axially accessible through the open area to be attached to the receiving vessel. In more specific embodiments, the body section has first and second opposing ends defining a gap sized to permit the vessel to pass through.

Abstract: An access device includes a body, a first tube, a second tube, and a mechanism. The first and second tubes extend through the body. The mechanism operably couples the first and second tubes such that at least one tube is pivotable about an axis with respect to the other tube. The body may form a substantially fluid-tight seal at the incision. In another embodiment, the access device further includes a third tube extending through the body and the mechanism operably couples the tubes together such that at least two tubes are pivotable about the axis with respect to the remaining tube.

Abstract: A fixation device for a subcutaneous implantable medical device includes a deformable tip portion that reduces in width when coupled with a fixation tool such that implantation of the implantable medical device through tissue is facilitated. Upon release from the fixation tool, the fixation device returns to its initial shape and stably secures the position of the implantable medical device.

Abstract: Medical devices for filtering fluids flowing through a lumen and a method of forming medical devices. The devices can be used in vascular channels, urinary tracts, biliary ducts and the like, and filter emboli and other debris generated at a treatment site.

Abstract: The invention relates to a system for dilatation of a body passage and delivery of a stent into the body passage of a patient, and related methods of using such a system. The dilatation and stent delivery system may comprise a dilatation catheter having an expandable member on a distal end, and a stent delivery catheter configured to retain a stent and deliver the stent to a body passage. The stent delivery catheter defines a lumen sized to receive the dilatation catheter and permit movement of the dilatation catheter relative to the stent delivery catheter.

Abstract: Methods, systems and apparatus for relieving pressure in an organ such as, but not limited to, the eye are disclosed. The method includes implanting a bioabsorbable, channel into the selected area of the organ using a delivery apparatus.

Abstract: The invention comprises: An introducer for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method of treating and angeological disease using a bifurcated stent; an endoluminal stent having perpendicular hoop members, each hoop member formed of wire in a sinuous configuration, at least some of juxtaposed apices in neighboring hoops being secured to one another, such stents also forming axially aligned segments in straight stents, and segments of bifurcated stents in particular embodiments. Certain embodiments of such stents also include barbs, fabric covering and radiopaque markers.

Abstract: A relatively inexpensive cannula is sized by including indica on a cannulated dilator that is used to measure the depth of a body cavity, and in one embodiment with the use of a cuttable fixture inserted into an initially enlarged dilator retractor made from a cuttable material the excess of the dilator retractor is snipped by a commercial cutter. A tool engaging the end of the cannulated dilator provides leverage on the cannulated dilator for rotation as it is forced into the body cavity, a pusher tool provides leverage on the dilator retractor for inserting the dilator retractor into the body cavity. A clamp that fits the top of the dilator retractor serves to support the dilator retractor through an arm to a rigid structure. In an alternate embodiment one of a series of sized dilator retractors are selected commensurate with the measurement attained by the scaled cannulated dilator.

Abstract: An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular occlusion by the endovascular insertion of a platinum wire and/or tip into the vascular cavity. The vascular cavity is packed with the tip to obstruct blood flow or access of blood in the cavity such that the blood clots in the cavity and an occlusion if formed. The tip may be elongate and flexible so that it packs the cavity by being folded upon itself a multiple number of times, or may pack the cavity by virtue of a filamentary or fuzzy structure of the tip. The tip is then separated from the wire mechanically or by electrolytic separation of the tip from the wire. The wire and the microcatheter are thereafter removed leaving the tip embedded in the thrombus formed within the vascular cavity. Movement of wire in the microcatheter is more easily tracked by providing a radioopaque proximal marker on the microcatheter and a corresponding indicator marker on the wire.

Abstract: An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular occlusion by the endovascular insertion of a platinum wire and/or tip into the vascular cavity. The vascular cavity is packed with the tip to obstruct blood flow or access of blood in the cavity such that the blood clots in the cavity and an occlusion if formed. The tip may be elongate and flexible so that it packs the cavity by being folded upon itself a multiple number of times, or may pack the cavity by virtue of a filamentary or fuzzy structure of the tip. The tip is then separated from the wire mechanically or by electrolytic separation of the tip from the wire. The wire and the microcatheter are thereafter removed leaving the tip embedded in the thrombus formed within the vascular cavity. Movement of wire in the microcatheter is more easily tracked by providing a radioopaque proximal marker on the microcatheter and a corresponding indicator marker on the wire.

Abstract: An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular occlusion by the endovascular insertion of a platinum wire and/or tip into the vascular cavity. The vascular cavity is packed with the tip to obstruct blood flow or access of blood in the cavity such that the blood clots in the cavity and an occlusion if formed. The tip may be elongate and flexible so that it packs the cavity by being folded upon itself a multiple number of times, or may pack the cavity by virtue of a filamentary or fuzzy structure of the tip. The tip is then separated from the wire mechanically or by electrolytic separation of the tip from the wire. The wire and the microcatheter are thereafter removed leaving the tip embedded in the thrombus formed within the vascular cavity. Movement of wire in the microcatheter is more easily tracked by providing a radioopaque proximal marker on the microcatheter and a corresponding indicator marker on the wire.