Abstract: Devices, systems, and methods deliver implantable medical devices for ventricular-from-atrial (VfA) cardiac therapy. A VfA device may be implanted in the right atrium (RA) with an electrode extending from the right atrium into the left ventricular myocardium. A flexible leed, or another probe, may be advanced to the potential implantation site and used to identify a precise location for implantation of a medical device, such as an electrode, leadlet, lead, or intracardiac device. Some methods may include locating a potential implantation site in the triangle of Koch region in the right atrium of a patient's heart; attaching a fixation sheath to the right-atrial endocardium in the potential implantation site; and implanting the medical device over a guide wire at the potential implantation site. An implantable medical device may include an intracardiac housing and a leadlet, which may be delivered by these methods.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: A medical fixation device which may include an elongate body with a proximal portion, a distal portion, and define a longitudinal axis extending therethrough. A first fixation member on the proximal portion of the elongate body and a second fixation member on the distal portion of the elongate body may also be included with the medical fixation device. The first fixation member and the second fixation member may each have a delivery configuration in which the first fixation member and the second fixation member are collapsed along the longitudinal axis, and an anchoring configuration in which the first fixation member and the second fixation member each extend radially outward from the elongate body, define a septal aperture therebetween, and each have a tip facing away from each other.

Abstract: Systems, devices, and methods may be used to deliver and provide cardiac pacing therapy to a patient. Leads or leadlets carrying one or more left ventricular electrodes may be positioned in or near the interventricular septum to sense and pace left ventricular signals of the patient's heart. In one example, a leadlet including one or more left ventricular electrodes may extend in the coronary sinus from a leadless implantable medical device located in the right atrium.

Abstract: A tool includes a handle, a plunger actuator proximate the handle, a shaft extending from the handle, a plunger, an engagement mechanism. The shaft includes a proximal end and a distal end, and the shaft defines a channel extending along a length of the shaft. A first actuation of the plunger actuator causes the plunger to translate along the length of the shaft in a distal direction. A second actuation of the plunger actuator causes the plunger to translate along the length of the shaft in a proximal direction. The engagement mechanism is disposed on the distal end and is configured to engage an implantable medical device, and release the implantable medical device in response to the plunger exerting a contact force on the implantable medical device exceeding a reaction force of the engagement mechanism when the plunger translates along the length of the shaft in the distal direction.

Abstract: The medical device may comprise an elongate body having a proximal portion, a distal portion, and defining a lumen therethrough. Also, the medical device may include an expandable element coupled to the distal portion of the elongate body and in fluid communication with the lumen. The expandable element may define a first end and a second end, the second end being proximal to the first end. The medical device may further include a cannula surrounding at least a portion of the elongate body and the cannula may define a proximal end and a distal end. The distal end of the cannula may be disposed proximal and adjacent to the second end of the expandable element. An outer dimctcr diameter of the cannula may be substantially equal to or lesser than an outer diameter of the expandable element when inflated. The medical device may be maneuvered through a patient's body.

Abstract: A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Abstract: A method includes locating the triangle of Koch region in the right atrium of a patient's heart; securing at least one electrode of an implantable lead or device to cardiac tissue from the triangle of Koch region to deliver ventricle-from-atrium (VfA) cardiac therapy; and testing the location or depth of the at least one electrode to configure VfA cardiac therapy. Locating the target implant region in the triangle of Koch region may include detecting an atrial slow pathway potential (ASP) or atrial pacing output.

Abstract: A medical system comprising a guiding catheter having an inflation lumen. The inflation lumen extends within a handle and a shaft of the guiding catheter. An inflatable sleeve has a proximal end and a distal end, with the ends attached to the guiding catheter. A sealed interior portion of the inflatable sleeve is bounded by the inflatable sleeve and the shaft of the guiding catheter, and in fluid communication with a distal port of the inflation lumen. The system further comprises a delivery catheter defining a delivery lumen and configured for sliding engagement within the guide lumen of the guiding catheter.

Abstract: An implantable medical device delivery system includes a delivery catheter including an elongated body with a first portion defining a first lumen and a second portion defining a second lumen. An angle is defined between a first axis and a second axis defined by the first and second portions, respectively. The second axis points toward the left ventricular (LV) apex of the patient's heart when the first axis points into the CS. The first portion or an elongated element may extend into the CS to anchor the delivery catheter to the orientation of the CS.

Abstract: Systems, devices, and methods may be used to deliver and provide cardiac pacing therapy to a patient. Leads or leadlets carrying one or more left ventricular electrodes may be positioned in or near the interventricular septum to sense and pace left ventricular signals of the patient's heart. In one example, a leadlet including one or more left ventricular electrodes may extend in the coronary sinus from a leadless implantable medical device located in the right atrium.

Abstract: A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.

Abstract: A method includes locating the triangle of Koch region in the right atrium of a patient's heart; securing at least one electrode of an implantable lead or device to cardiac tissue from the triangle of Koch region to deliver ventricle-from-atrium (VfA) cardiac therapy; and testing the location or depth of the at least one electrode to configure VfA cardiac therapy. Locating the target implant region in the triangle of Koch region may include detecting an atrial slow pathway potential (ASP) or atrial pacing output.

Abstract: A medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.

Abstract: The medical device may comprise an elongate body having a proximal portion, a distal portion, and defining a lumen therethrough. Also, the medical device may include an expandable element coupled to the distal portion of the elongate body and in fluid communication with the lumen. The expandable element may define a first end and a second end, the second end being proximal to the first end. The medical device may further include a cannula surrounding at least a portion of the elongate body and the cannula may define a proximal end and a distal end. The distal end of the cannula may be disposed proximal and adjacent to the second end of the expandable element. An outer dimeter of the cannula may be substantially equal to or lesser than an outer diameter of the expandable element when inflated. The medical device may be maneuvered through a patient's body.

Abstract: A medical fixation device which may include an elongate body with a proximal portion, a distal portion, and define a longitudinal axis extending therethrough. A first fixation member on the proximal portion of the elongate body and a second fixation member on the distal portion of the elongate body may also be included with the medical fixation device. The first fixation member and the second fixation member may each have a delivery configuration in which the first fixation member and the second fixation member are collapsed along the longitudinal axis, and an anchoring configuration in which the first fixation member and the second fixation member each extend radially outward from the elongate body, define a septal aperture therebetween, and each have a tip facing away from each other.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: An implantable medical device delivery system includes a delivery catheter including an elongated body with a first portion defining a first lumen and a second portion defining a second lumen. An angle is defined between a first axis and a second axis defined by the first and second portions, respectively. The second axis points toward the left ventricular (LV) apex of the patient's heart when the first axis points into the CS. The first portion or an elongated element may extend into the CS to anchor the delivery catheter to the orientation of the CS.

Abstract: This disclosure provides tools and implant techniques utilizing such tools to gain access to and implant a medical device, such as a medical electrical lead, within extravascular spaces. In one example, this disclosure provides a tool for creating a sub-sternal tunnel in a patient. The tool comprises a relatively straight guide member extending from a first end thereof to a second end thereof, a tunneling member extending from a first end thereof to a tip thereof, the tunneling member extending alongside and coplanar with the guide member, the first end of the tunneling member and the first end of the guide member being joined together, and a handle coupled to the guide member.

Abstract: Devices, systems, and methods deliver implantable medical devices for ventricular-from-atrial (VfA) cardiac therapy. A VfA device may be implanted in the right atrium (RA) with an electrode extending from the right atrium into the left ventricular myocardium. A flexible leed, or another probe, may be advanced to the potential implantation site and used to identify a precise location for implantation of a medical device, such as an electrode, leadlet, lead, or intracardiac device. Some methods may include locating a potential implantation site in the triangle of Koch region in the right atrium of a patient's heart; attaching a fixation sheath to the right-atrial endocardium in the potential implantation site; and implanting the medical device over a guide wire at the potential implantation site. An implantable medical device may include an intracardiac housing and a leadlet, which may be delivered by these methods.