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 hemostatic valve couples to a sheath proximal hub having an inside and an outside surface. The hemostatic valve has a valve body having a proximal porting and end, and a distal portion and end. A passageway extends longitudinally through the valve body between the proximal and distal ends. A sealing element is positioned within the passageway. The distal portion of the valve body includes a pair of contact surfaces forming an annular gap receiving the sheath proximal hub of the sheath so that the contact surfaces sandwich the sheath proximal hub forming a seal on both the inside and outside surfaces of the hub. The valve body and the sheath proximal hub includes two oppositely placed longitudinal lines of fissure that allow the hub to be separated into two halves with the valve body.

Abstract: A device for support and protection of a tubular element having a single-piece construction, an open configuration and a closed configuration, comprising: a base portion, a side-portion and at least one living hinge interconnecting the side-portion to the base portion. The base portion comprises a plurality of recesses on a surface, each recess being delimited by a plurality of pins, each pin having an indentation. The plurality of indentations form a pocket by which the tubular element is held. The at least one living hinge opens such that the side-portion is substantially parallel to the base portion in the open configuration and the at least one living hinge closes such that the side-portion forms a protective shell about the base portion in the closed configuration.

Abstract: Disclosed is ultrasonic medical probe (10) connectable to a Doppler signal generator and processor for detecting or measuring blood flow in a vessel. In one embodiment, the distal portion (52) of the probe comprises an outer sheath (17) that includes a malleable shapeable portion (16), such as an annealed stainless steel cannula, to which a transducer head (11) containing one or more ultrasonic transducers (12), is mounted distally. Two wires (14, 15), comprising the electrical conductor (13), extend through the outer sheath from each ultrasonic transducer to a proximal connector (19). The shapeable portion can be contoured before or during a procedure, such as to access the natural spaces within brain to read flow in a cerebral artery.

Abstract: Disclosed is a lead removal apparatus for removing an implanted pacemaker or defibrillator lead from the heart. The lead removal apparatus includes a proximal handle that further includes a proximal portion, such as an elongate section of intertwined wire, having a compact, pre-formed first configuration, such as one or more coiled loops. The compact shape permits the operator to utilize the proximal portion without requiring the assistance of a second person to help keep it within the sterile field during a procedure. The operator is thus able to constrain or uncoil the proximal portion into a second configuration that is sufficiently straight such that a medical device, such as a dilator sheath, can be advanced thereover to help separate the lead from scar tissue along the vein path. The proximal portion may include sufficient resiliency to substantially return to the first configuration once the sheath has been advanced.

Abstract: A splittable medical valve is disclosed that is configured with a interfacing region that permits the valve to be placed over or inside of a tubular medical device, such as a splittable introducer sheath, to prevent loss of bodily fluids and/or reduce ingress of air-borne pathogens. The valve further includes a sealing element configured to accept passage of a medical device, such as a catheter, sheath, pacemaker lead, or other ancillary device therethrough, whereby the valve body is split along one or more lines or fissure to allow removal of the valve from around the ancillary device.

Abstract: Disclosed is a heart lead removal apparatus for removing an range of different sized implanted cardiac pacemaker or defibrillator leads from the heart, typically through a blood vessel leading to the heart. The lead removal apparatus comprises a stylet, an expandable portion, and an actuator portion which is manually advanced by the operator to cause the expandable portion to engage the coils within a pacemaker coil lumen. In one preferred embodiment, the expandable portion comprises a multifilar wire bundle that is helically wound around the stylet and attached about the tip thereof. The actuator portion, which comprises an elongate metal cannula attached to a first handle, is urged forward to contact the proximal end of the expandable portion, thereby causing the individual wires of the multifilar wire bundle to deform outward in a random fashion.

Abstract: Disclosed is a lead removal apparatus for removing an implanted pacemaker or defibrillator lead from the heart. The lead removal apparatus includes a proximal handle that further includes a proximal portion, such as an elongate section of intertwined wire, having a compact, pre-formed first configuration, such as one or more coiled loops. The compact shape permits the operator to utilize the proximal portion without requiring the assistance of a second person to help keep it within the sterile field during a procedure. The operator is thus able to constrain or uncoil the proximal portion into a second configuration that is sufficiently straight such that a medical device, such as a dilator sheath, can be advanced thereover to help separate the lead from scar tissue along the vein path. The proximal portion may include sufficient resiliency to substantially return to the first configuration once the sheath has been advanced.

Abstract: An introducer apparatus (10) comprising a pair of co-extending splittable introducer sheaths (11), (12) is disclosed. The unique properties (pushability, torqueability, length, shape, etc.) of the individual introducer sheaths yields an introducer apparatus with the additional navigational flexibility to reach a remote target that whose access would be more difficult or impossible with a single introducer sheath. One embodiment include a coaxial pair of introducer sheaths made of made of molecularly oriented (non-isotropic) polytetrafluoroethylene PTFE which are used for placement of a pacemaker or defibrillator lead into the coronary sinus. In this embodiment, the first introducer sheath (11) is introduced over a wire guide into ostium of the coronary sinus, which represents the first target site. The outer introducer sheath includes preformed bends (20) to facilitate passage through the vasculature.

Abstract: A medical device (10) such as a radio frequency dilator sheath for separating an encapsulated elongated structure (11) such as an electrical cardiac lead implanted in biological tissue (12) such as a vessel leading to or from a patient's heart. The radio frequency dilator sheath includes inner and outer coaxial dilator sheaths (13 and 28) with respective beveled distal ends (18 and 36) for mechanically loosening and separating encapsulating tissue from an implanted electric cardiac lead. The beveled distal end of the inner sheath is truncated to form a transverse face or surface (89) that is approximately perpendicular to the longitudinal axis of the sheath. Electrical conductors (16 and 17) are positioned about the distal end (14) and passage (15) of the inner dilator sheath.

Abstract: Disclosed is ultrasonic medical probe (10) connectable to a Doppler signal generator and processor for detecting or measuring blood flow in a vessel. In one embodiment, the distal portion (52) of the probe comprises an outer sheath (17) that includes a malleable shapeable portion (16), such as an annealed stainless steel cannula, to which a transducer head (11) containing one or more ultrasonic transducers (12), is mounted distally. Two wires (14, 15), comprising the electrical conductor (13), extend through the outer sheath from each ultrasonic transducer to a proximal connector (19). The shapeable portion can be contoured before or during a procedure, such as to access the natural spaces within brain to read flow in a cerebral artery.

Abstract: Disclosed is a heart lead removal apparatus for removing an range of different sized implanted cardiac pacemaker or defibrillator leads from the heart, typically through a blood vessel leading to the heart. The lead removal apparatus comprises a stylet, an expandable portion, and an actuator portion which is manually advanced by the operator to cause the expandable portion to engage the coils within a pacemaker coil lumen. In one preferred embodiment, the expandable portion comprises a multifilar wire bundle that is helically wound around the stylet and attached about the tip thereof. The actuator portion, which comprises an elongate metal cannula attached to a first handle, is urged forward to contact the proximal end of the expandable portion, thereby causing the individual wires of the multifilar wire bundle to deform outward in a random fashion.

Abstract: Disclosed is a lead removal apparatus for removing an implanted pacemaker or defibrillator lead from the heart. The lead removal apparatus includes a proximal handle that further includes a proximal portion, such as an elongate section of intertwined wire, having a compact, pre-formed first configuration, such as one or more coiled loops. The compact shape permits the operator to utilize the proximal portion without requiring the assistance of a second person to help keep it within the sterile field during a procedure. The operator is thus able to constrain or uncoil the proximal portion into a second configuration that is sufficiently straight such that a medical device, such as a dilator sheath, can be advanced thereover to help separate the lead from scar tissue along the vein path. The proximal portion may include sufficient resiliency to substantially return to the first configuration once the sheath has been advanced.