Abstract: A tip engageable with an elongated sheath member for extracting an implanted elongated structure, such as a cardiac lead, from an obstruction in a body vessel of a patient. The tip includes a tip body having a proximal end, a distal end, and a passageway extending therethrough. The tip body proximal end is engageable with the distal end of the sheath member distal end. The passageway of the tip is aligned with the passageway of the sheath such that the implanted structure is receivable therein. The tip body distal end includes a segment tapering toward a leading edge. A disrupter element, such as a plurality of helices, is disposed along the outer surface of the tip body distal end. The disruptor element is configured for non-cuttingly disrupting the obstruction as the tip is advanced over the implanted structure.

Abstract: An entry device for providing access to the interior of a body vessel through a wall of the vessel to enable removal of an implanted structure, such as a cardiac lead, from the body vessel includes an elongated sheath member and a tip positioned at the distal end of the sheath member. The elongated sheath member and tip have respective passageways extending therethrough that are sized and aligned to receive the implanted structure therein upon accessing the vessel. The elongated sheath member is capable of delivering sufficient torque to permit advancement of the tip through a wall of the vessel. The device may include an optional handle, and may be driven by manual or mechanical action.

Abstract: A collar for anchoring a lead in a vein. The collar includes a body member having axial ends and a throughbore extending between the axial ends. The throughbore is sized for receiving at least a portion of the lead. The body member includes one or more grooves disposed along its outer surface for receiving a suture for anchoring the lead. At least a portion of the inner surface of the body member includes structure sized and positioned to project into the throughbore for generating a tangential compression against the lead, thereby inhibiting slippage of the lead when the lead is received in the throughbore.

Abstract: A tip for engagement with an elongated sheath member for use in extracting an implanted structure, such as a cardiac lead, from an obstruction in a body vessel of a patient. The tip includes a tip body having a smaller diameter proximal end and a larger diameter distal end. The smaller diameter proximal end of the tip is sized for engagement with an inner surface of the distal end of the sheath member. The larger diameter distal end of the tip includes at least one element disposed along at least a portion of the outer surface of the tip body distal end. The element has a shape configured for cutting and/or disrupting the lead from the obstruction.

Abstract: An extraction device for removing an implanted structure, such as a cardiac lead, from a body vessel. An elongated sheath having a proximal end, a distal end, and a passageway extending therethrough is sized such that at least a distal portion of the sheath is receivable in the body vessel. A tip configured for disassociating at least a portion of the implanted structure from the body vessel is engaged at the distal end of the sheath. A handle is configured for engagement with the proximal end of the sheath. The handle includes an actuator and a drive mechanism responsive to the actuator for selectively translating input of the actuator into rotary movement and/or axial advancement of the sheath.

Abstract: A modular hemostatic valve includes a splittable valve body. The splittable body defines a passageway. A sealing element positions in the passageway. The sealing element is configured to facilitate the passage of a first medical device, and the splittable valve body is configured to engage a second medical device.

Abstract: A device for removing from a patient a previously implanted elongated structure, such as a pacemaker lead or a defibrillator lead, that may be encapsulated in biological tissue of the patient. In one form, the device comprises a sheath member having an inside dimension greater than the outside dimension of the elongated structure, and a gripping member positioned about the sheath member. The gripping member has a longitudinal passage extending substantially therethrough, which longitudinal passage is dimensioned to encircle at least a portion of the elongated structure. A proximal portion of the gripping member may extend outwardly beyond the proximal end of the elongated structure and outwardly of at least the vascular system of the patient.

Abstract: Heart lead removal apparatus for removing an implanted cardiac pacemaker lead from the wall of a heart through a blood vessel leading to the heart. The lead removal apparatus comprises an outer tube sized for insertion into the coiled structure passageway of the pacemaker lead; an anchoring projection positioned proximate the distal end of the outer tube; and a stylet positioned through the passageway of the outer tube for urging the anchoring projection between relaxed and hooked positions. In the hooked position, the projection extends outwardly from the outer tube and when also positioned in the coiled structure passageway, hooks into the coiled structure for facilitating removal of the lead from the heart. In the relaxed position, the anchoring projection is insertable into the coiled structure passageway.

Abstract: A noninvasive, perforate, self-centering locator (10) facilitates engagement of a needle or cannula with a vascular access device (44) of the type having a subcutaneously implanted infusion port (46) and an infusion chamber (48) contained in the infusion port (46), the infusion chamber (48) being covered by a septum (52). The locator (10) is exemplified by a port stabilizer ring (12) having a central opening (18) with an interior diameter greater than the diameter of the septum (52) but less than the greatest diameter of the infusion port (46). The stabilizer ring (12) or other embodiment of the locator (10) is pressed on the skin (45) over the site of the infusion port (46), and simultaneously visually locates the septum (52) for the user while stabilizing the infusion port (46) with respect to the skin (45) and underlying tissues, permitting ready penetration of the skin (45) and septum (52) by a needle or cannula (58).

Abstract: A pulsed Doppler probe 10 for monitoring blood flow within a blood vessel 12 includes a sheath 17 and a plurality of electrically conductive wires 26 extending through the sheath 17. The wires 26 have distal ends 28 to which an ultrasonic transducer 18 is operatively connected. The transducer 18 has an operative surface 20, and the probe 10 also includes a means 22 for fixing the orientation of the operative surface 20 with respect to at least one of a longitudinal axis 38 of the sheath 17, and the orientation fixing means 22, or with respect to the distal ends 28 of the electrically conductive wires 26. The orientation fixing means 22 includes an epoxy material 24 encasing the ultrasonic transducer 18, shaped to include a cylindrically concave surface 30. The probe 10 further includes a mesh band 44 of at least one of an absorbable material and an inert material adapted to encircle the blood vessel 12.

Abstract: A locally flexible dilator sheath (10) for separating encapsulating tissue from an implanted cardiac electrical lead. The dilator sheath includes an elongated tubular member (11) of a rigid stainless steel material, which is sized for placement of the tubular member over a cardiac lead that is implanted in the vascular system of a patient. The distal end (13) of the rigid tubular member is beveled to ease the separation of extremely tough tissue that encapsulates an implanted cardiac lead. To ease insertion around curves in the vascular system of the patient, the elongated tubular member includes a relieved portion (14). The relieved portion includes a relief pattern (15) of apertures (16,17,19,23) in the elongated tubular member. The relief apertures preferably include diametrically opposed slots (24,25) that extend perpendicularly into the tubular member. Adjacent pairs (44,45) of slots are circumferentially offset a 90.degree. angle (26) to add further lateral flexibility to the relieved portion.

Abstract: Heart lead removal apparatus and method are disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. The wire coil includes first, second, and third pluralities of turns. The first plurality of turns is positioned around and about the distal end of the stylet wire for radially expanding when in the passageway of the lead to secure the stylet wire to the lead. The second plurality of turns extends proximally from the first plurality of turns and laterally from the stylet wire for engaging the lead and radially expanding the first plurality of turns. The third plurality of turns extends distally from the first plurality of turns and is attached around and about the distal end of the stylet wire for cooperating in the radial expansion of the first plurality of turns when in the passageway of the lead.

Abstract: Heart lead removal apparatus and method are disclosed for removing a pacemaker lead from a heart through a blood vessel leading thereto. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the pacemaker lead. A lockable mechanism grasps the proximal end of the lead, and a wire guide is inserted in the passageway of the lead to determine its size and clear any blockage therein. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the pacemaker lead. The stylet wire is rotated in a direction to unwind and expand the wire coil and engage the coiled structure, thereby securing the stylet wire to the pacemaker lead. A tie secures the insulating material to the coiled structure of the lead at the proximal end thereof to limit motion and to apply a uniform extraction force to the entire lead.

Abstract: Heart lead removal apparatus and method are disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. A lockable mechanism grasps the proximal end of the lead, and a wire guide is inserted in the passageway of the lead to determine its size and any blockage therein. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the heart lead where the tip is typically secured to the heart wall with a number of tines formed from the insulating material surrounding the coiled structure. A tie secures the insulating material to the coiled structure of the lead at the proximal end thereof to limit motion and apply uniform extraction force to the entire lead.

Abstract: Heart lead removal apparatus is disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for engaging the coiled structure of the heart lead. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the heart lead where the tip is typically secured to the heart wall with a number of tines formed from the insulating material surrounding the coiled structure. When inserted, the stylet wire is rotated in a direction to unwind and expand the wire coil and engage the heart lead coiled structure, thereby securing the stylet wire to the heart lead. A separator tube is inserted over the proximal end of the stylet wire and the heart lead and moved along the entire length of the heart lead to first separate the restricted heart lead from the blood vessel leading to the heart cavity.

Abstract: Heart lead removal apparatus and method are disclosed for removing a heart lead from the wall of a heart through a blood vessel leading to the heart. The apparatus comprises a flexible stylet wire with an expandable wire coil attached to the distal end for securing the distal end of the stylet wire to the heat lead. A catch wire extends from the proximal end of the wire coil. The free end of the catch wire has a segment folded back on itself for engaging the coiled structure of the lead and expanding the wire coil when the stylet wire and wire coil are rotated in the passageway of the lead. The stylet wire is inserted in the longitudinal passageway of the coiled structure to the distal end of the heart lead. When inserted in the passageway, the stylet wire and wire coil are rotated in a direction to engage the catch wire with the coiled structure. The wire coil then expands engages the heart lead coiled structure, thereby securing the stylet wire to the heat lead.