Abstract: A surgical apparatus is disclosed for delivering a therapeutic device to a desired location within the vasculature of a patient, which includes an elongated tubular body defining a longitudinal axis and having opposed proximal and distal end portions, the tubular body including an outer wall surrounding an interior lumen, wherein an elongated target opening is formed through the outer wall of the tubular body within the distal end portion thereof in communication with the interior lumen. At least one distal sensing electrode is provided on the tubular body adjacent a distal side of the target opening, and at least one proximal sensing electrode is provided on the tubular body adjacent a proximal side of the target opening, wherein the sensing electrodes allow placement of the target opening within the vasculature of a patient for the delivery of a therapeutic device to a desired location.

Abstract: A steerable multi-polar lead shaft assembly includes a core member extending longitudinally through the shaft assembly, a plurality electrically conductive elements disposed within the core member, a plurality of steering wires circumferentially distributed about the core member. A control mechanism for a steerable catheter, such as the steerable multi-polar lead assembly, includes a mounting portion adapted to engage a steerable shaft, a stem extending from the mounting portion, a swivel joint arranged at a proximal end of the stem, a control yoke rotatably mounted on the swivel joint, adapted to engage a plurality of steering wires of the steerable catheter, and a handle connected with the yoke, adapted for direct manipulation by a user.

Abstract: A hemostasis valve for a vascular introducer includes a valve body having a seal region with opposed substantially planar proximal and distal end surfaces and a central axis extending through the seal region perpendicular to the proximal and distal end surfaces. The seal region has a first grouping of circumferentially arranged and equidistantly spaced linear cuts extending radially outward from the central axis, and through the seal region from the proximal end surface to the distal end surface. The seal region has a second grouping of circumferentially arranged and equidistantly spaced linear cuts in the distal end surface extending tangentially outward from the first grouping of linear cuts, and partially from the distal end surface to a depth short of the proximal end surface to facilitate passage of a variety of sizes of medical devices through the seal region.

Abstract: A steerable dilator includes a dilator body for holding and guiding a sheath, the dilator body having a deflectable distal end portion, and at least one lateral passage configured to accommodate at least one steering cable and a steering handle operatively associated with a proximal end portion of the dilator and having an actuation mechanism operatively connected to the at least one steering cable accommodated within the at least one lateral passages of the dilator for steering the deflectable distal end portion of the dilator in at least one direction.

Abstract: An electrical connector is disclosed that includes an annular housing having a central aperture for receiving a connector pin and an annular contact spring disposed concentrically within the annular housing and including a plurality of circumferentially spaced apart spring arms, each spring arm having a radially inwardly extending contact pad for resiliently contacting a connector pin inserted into the central aperture of the housing.

Abstract: A coronary sinus lead is disclosed that includes a lead body having opposed proximal and distal end portions, and an open-ended cavity formed in the distal end portion of the lead body for temporarily receiving an angioplasty balloon. The lead is configured for connection with a pacing device. A method of implanting the lead is also disclosed, which includes passing a coronary angioplasty balloon catheter over a length of guide wire extending through the coronary sinus, coronary veins, and collaterals so that the balloon is externalized. The method further includes inserting the balloon into an open cavity of the lead, inflating the balloon within the open cavity to temporarily engage a distal end portion of the lead to the catheter, and pulling the distal end portion of the lead though the coronary sinus and into a coronary vein by at least partially withdrawing the catheter from the coronary sinus.

Abstract: An implantable active fixation cardiac lead is disclosed that includes an elongated lead body having opposed proximal and distal end portions and having an interior lumen extending therethrough, an axially rotatable extendable and retractable fixation helix operatively associated with the distal end portion of the lead body, a rotatable in-line quadripolar connector assembly operatively associated with the proximal end portion of the lead body and including an elongated rotatable pin electrode having opposed proximal and distal end portions, and an elongated torque transmitting conductor coil extending through the interior lumen of the lead body and having a proximal end portion connected to the distal end portion of the rotatable pin electrode and a distal end portion connected to the rotatable fixation helix, to facilitate manual activation of the fixation helix.

Abstract: A balloon catheter includes a first outer tubular member, a second inner tubular member, an inflatable balloon, and a drug coating applied to at least a portion of the inflatable balloon. The inflatable balloon has opposing distal and proximal end portions. The inflatable balloon resides on the first and second tubular members in a twisted turn orientation of a pre-determined angle relative to the proximal end portion of the inflatable balloon attached to the first outer tubular member, such that the second inner tubular member achieves a constant torque of the balloon to twist and fold itself when retracted back into a portion of the first outer tubular member. Folds caused by the twisted turn orientation are configured and adapted to protect the drug coating while the inflatable balloon is deflated, thereby reducing premature drug elution and increasing the reliability and consistency of drug delivery.

Abstract: A system for use with an implantable lead wire includes an implantable electronic apparatus configured to generate an electrical signal. An implantable lead adaptor is operatively disposed between the proximal end of the implantable lead wire and the implantable electronic apparatus. A band stop filter is housed within the implantable lead adaptor and electrically coupled in series with the implantable lead wire and the implantable electronic apparatus.

Abstract: A hemostasis valve for a vascular introducer includes a valve body having a seal region with opposed substantially planar proximal and distal end surfaces and a central axis extending through the seal region perpendicular to the proximal and distal end surfaces. The seal region has a first grouping of circumferentially arranged and equidistantly spaced linear cuts extending radially outward from the central axis, and through the seal region from the proximal end surface to the distal end surface. The seal region has a second grouping of circumferentially arranged and equidistantly spaced linear cuts in the distal end surface extending tangentially outward from the first grouping of linear cuts, and partially from the distal end surface to a depth short of the proximal end surface to facilitate passage of a variety of sizes of medical devices through the seal region.

Abstract: A coronary sinus lead is disclosed that includes a lead body having opposed proximal and distal end portions, and an open-ended cavity formed in the distal end portion of the lead body for temporarily receiving an angioplasty balloon. The lead is configured for connection with a pacing device. A method of implanting the lead is also disclosed, which includes passing a coronary angioplasty balloon catheter over a length of guide wire extending through the coronary sinus, coronary veins, and collaterals so that the balloon is externalized. The method further includes inserting the balloon into an open cavity of the lead, inflating the balloon within the open cavity to temporarily engage a distal end portion of the lead to the catheter, and pulling the distal end portion of the lead though the coronary sinus and into a coronary vein by at least partially withdrawing the catheter from the coronary sinus.

Abstract: An implantable active fixation cardiac lead is disclosed that includes an elongated lead body having opposed proximal and distal end portions and having an interior lumen extending therethrough, an axially rotatable extendable and retractable fixation helix operatively associated with the distal end portion of the lead body, a rotatable in-line quadripolar connector assembly operatively associated with the proximal end portion of the lead body and including an elongated rotatable pin electrode having opposed proximal and distal end portions, and an elongated torque transmitting conductor coil extending through the interior lumen of the lead body and having a proximal end portion connected to the distal end portion of the rotatable pin electrode and a distal end portion connected to the rotatable fixation helix, to facilitate manual activation of the fixation helix.

Abstract: A medical device compatible with magnetic resonance imaging including an elongated tubular body defining a longitudinal axis and having opposed proximal and distal end portions. The elongated body including a plurality of coaxial layers including a radially inner-most insulative layer, at least one inner conductive layer, and a radially outer-most insulative layer. The at least one conductive layer is defined by a non-ferromagnetic conductive material that is compatible with magnetic resonance imaging.

Abstract: A vascular introducer includes a proximal hub portion with an interior bore, an elongated sheath extending distally from the hub portion, with a lumen in communication with the interior bore of the hub portion, and a hemostatic valve disposed within the bore of the hub portion. The hemostatic valve has a passage extending therethrough, and includes a sealing flap movable between an open position relative to the passage and a closed position relative to the passage.

Abstract: A method of inserting a pacing lead having a preformed shape into a coronary sinus to pace the left atrium includes providing a lead having an elongated body and proximal and tip sections. The sections are configured such that a first angle less than 90 degrees is defined between the lead body and proximal section and a second angle is defined between the tip and proximal sections. The method further comprises advancing the pacing wire towards the opening of the coronary sinus and advancing the wire into the coronary sinus, such that the first angle is compressed by the coronary sinus opening and a tip electrode included on the tip section contacts the wall of the coronary sinus near the left atrium operably extending the second angle to assure constant contact between the wall of the coronary sinus and the tip electrode.

Abstract: A catheter assembly including a tubular assembly consisting of an inner tubular member slidably received within an outer tubular member such that a distal end portion of the inner tubular member extends distally from a distal end of the outer tubular member. The catheter assembly further includes a balloon member having first and second end regions wherein a first end region is attached to the distal end portion of the inner tubular member and the second end region is attached to the distal end portion of the outer tubular member.

Abstract: A pacing lead for implantation in a coronary sinus having an opening and a wall defining an interior and presenting a diameter dimension. The pacing lead includes an elongated lead body, a resilient fixation element, and at least one electrode on either the lead body or the fixation element. The fixation element extends from the pacing portion and defines a loop structure laterally adjacent the pacing portion. The loop structure presents a predetermined width dimension greater than the diameter dimension of the coronary sinus, wherein when the loop structure is inserted into the opening of the coronary sinus, the loop structure is laterally compressed by the wall of the coronary sinus and the electrode is biased against the wall of the coronary sinus.

Abstract: An active fixation cardiac lead is disclosed that includes an elongated lead body having opposed proximal and distal end portions and an interior lumen that extends therethrough. A rotatable fixation element is operatively associated with the distal end portion of the lead body and a tubular torque-transmitting member extends through the interior lumen of the lead body. The tubular torque-transmitting member has a distal end connected to the fixation element and a proximal end connected to a rotatable actuator operatively associated with the proximal end portion of the lead body. Preferably, the rotatable actuator is part of a connector assembly that is operatively associated with the proximal end portion of the lead body.