Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: A mapping and ablation catheter that reduces the risk of cardiac perforation during diagnostic and therapeutic procedures. The catheter comprises an elongate shaft including a proximal and distal portions, where the distal portion comprises a plurality of segments including a proximal-most segment, a distal-most segment and one or more intermediate segments between the proximal-most and distal-most segments. The catheter can include a diagnostic electrode in the distal most segment, an atraumatic tip located at the distal end of the distal-most segment, and an ablation electrode located in a segment proximal to the distal-most segment.

Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: The preparation and use of medical devices having radiopaque and echogenic materials including coated tungsten and/or tungsten carbide particles are disclosed herein.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device, the kit comprising an outer sheath, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a tapered distal end. The inner sheath is slidable within the inner lumen of the outer sheath and is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath. The kit includes an elongated deployment receptacle including a deployment bay slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath. The deployment bay carries an implantable medical device through the inner lumen of the outer sheath and facilitates deployment of the implantable medical device from the distal end of the outer sheath.

Abstract: In one example, this disclosure is directed to a method for intravascular implantation of an implantable medical device comprising positioning a distal end of an elongated outer sheath forming an inner lumen adjacent a target site within a vasculature of a patient, and partially deploying an implantable medical device from the distal opening, wherein the implantable medical device includes an expandable fixation element. A portion of the expandable fixation element assumes an expanded position when the implantable medical device is partially deployed from the distal opening. The method including advancing the distal end of the outer sheath within the vasculature with the implantable medical device partially deployed from the distal opening, and monitoring at least one of the vasculature and the portion of the expandable fixation element for deflection to determine when the size of the portion of the expandable fixation element corresponds to the size of the vasculature.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath forming a second inner lumen. An outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen. The second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device. The inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an inflatable member at its distal portion. The inflatable member is inflatable from a proximal end of the inner sheath to close-off the distal opening of the outer sheath when inflated. The inner sheath further includes a stopper proximally located relative to the inflatable member. The inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper. The inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath.

Abstract: In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an enlarged distal portion, wherein the enlarged distal portion is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath. The enlarged distal portion is slidable relative to the outer sheath. The inner sheath further includes a tether with a helical element that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from a distal portion of the outer sheath.

Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: Devices and methods for implanting leads along a spinal cord include an introducer having a main body defining a lumen and one or more collapsible and expandable side sheaths attached to the main body. The side sheaths may be collapsed as the introducer is positioned in a desired location of a patient to maintain a low profile. Once the introducer is placed, the side sheaths may be expanded to receive a lead. A lead may also be inserted through a lumen of the main body. Once the leads are inserted, the introducer may be withdrawn over the leads, leaving the leads implanted in the desired region in a desired orientation.

Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: A catheter for implanting a cardiac pacing electrode within a right atrial septum, to stimulate the His bundle, includes a deflectable shaft having a wall that includes an adjustable segment, a pre-formed segment and a substantially straight distal segment. The pre-formed segment extends distally from a pull wire anchoring member of the adjustable segment and out of a single plane in which the adjustable segment is deflectable; and the substantially straight distal segment extends distally, directly from the pre-formed segment, along a plane oriented at an angle with respect to that in which the adjustable segment is deflectable, and over a length between approximately seven and nine millimeters. An arc through which the pre-formed segment extends is preferably greater than approximately 80 degrees and less than approximately 130 degrees, and the angle of the plane of the distal segment is preferably between approximately 40 and 60 degrees.

Abstract: Methods, devices and assemblies for anchoring implanted medical electrical leads employed in the stimulating and/or sensing of signals in tissue are disclosed. The devices include a lead anchoring clip having a central hub portion, an anchoring portion for coupling to tissue and a lead engagement mechanism that couples the clip to a medical electrical lead.

Abstract: An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Abstract: Bio-impedance may be used for navigation systems to chronically implant pacing and defibrillation leads in the heart using a non-fluoroscopic position sensing unit (PSU). Such a system requires that a conductive material, such as a retractable helical tip-electrode, be exposed during implantation. Since the tip is retracted during implantation, this disclosure provides a modified distal portion employing at least one aperture (or “window”) for fluid exposure of the helix-electrode and a deployable internal sleeve for covering the aperture(s) when the helix-electrode is extended.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: Systems for gaining access into a body of a patient around an implanted body of an elongate medical device include a sheath having a deformable wall that allows insertion of the device body into a lumen surrounded by the sheath wall. The sheath wall may include first and second edges that extend from a proximal end to a distal end of the lumen, or just extend along a distal portion of the lumen. A tool, which includes a groove sized to grasp about a circumference of the device body, may facilitate insertion of the device body into the lumen of those sheath embodiments that include the first and second edges, by spreading at least one of the first and second edges of the wall apart from the other of the first and second edges while the device body is grasped within the tool.

Abstract: Devices and methods for implanting leads along a spinal cord include an introducer having a main body defining a lumen and one or more collapsible and expandable side sheaths attached to the main body. The side sheaths may be collapsed as the introducer is positioned in a desired location of a patient to maintain a low profile. Once the introducer is placed, the side sheaths may be expanded to receive a lead. A lead may also be inserted through a lumen of the main body. Once the leads are inserted, the introducer may be withdrawn over the leads, leaving the leads implanted in the desired region in a desired orientation.