Abstract: Implantation of a cardiac stimulus system into the mediastinum using the ITV. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed using the brachiocephalic vein to access the ITV, with access to the brachiocephalic vein achieved using subclavian vein, using standard visualization techniques. Inferior access may be accomplished inferior to the lower rib margin via the superior epigastric vein. Intercostal access may include creating an opening in an intercostal space between two ribs and advancing a needle using ultrasound guidance.

Abstract: Implantation of a cardiac stimulus system using parasternal access to the ITV is provided. Superior access may be achieved using parasternal locations in the upper ribcage to access the ITV. Inferior access may be achieved using parasternal locations in the lower ribcage to access the ITV. Parasternal access may include creating an opening in an intercostal space between two ribs and advancing a needle using ultrasound guidance.

Abstract: Implantable devices and systems include one or more leads adapted to be emplaced in the internal thoracic vein (ITV) of a patient. The lead may include features to adapt the lead for such placement. An associated device for use with the lead may include operational circuitry adapted for use with a lead having an electrode for sensing and/or therapy purposes coupled thereto. Methods for implantation and use of such devices and systems are disclosed as well.

Abstract: Implantable devices and systems include one or more leads adapted to be emplaced in the internal thoracic vein (ITV) of a patient. The lead may include features to adapt the lead for such placement. An associated device for use with the lead may include operational circuitry adapted for use with a lead having an electrode for sensing and/or therapy purposes coupled thereto. Methods for implantation and use of such devices and systems are disclosed as well.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: In accordance with various aspects of the invention, copolymers comprising styrene and isobutylene monomers are used in the construction of implantable and insertable medical devices for electrical stimulation, including, for example, electronic signal generating components and electrical leads for such devices.

Abstract: Tunneling tools and systems comprising electrodes and tunneling tool. In some examples the tunneling tools have a width that is greater than thickness, or may have enlarged portions to allow tunneling of a space. The tunneling tools may have expandable dissection portions including expandable balloons, linkages and/or springs in different examples. Systems may include tunneling tools with a lumen for receiving a lead having an electrode in a collapsed configuration, where the electrode is designed to expand once placed in a patient, with the tunneling tool designed to create a space in which the electrode can expand.

Abstract: A subcutaneous implantable cardioverter-defibrillator (S-ICD) comprising shocking electrodes configured to reduce the defibrillation threshold. The S-ICD may include a canister housing a source of electrical energy, a capacitor, and operational circuitry that senses heart rhythms and an electrode and lead assembly. The electrode and lead assembly may comprise a lead, at least one sensing electrode, and at least one shocking electrode. The at least one shocking electrode may extend over a length in the range of 50 to 110 millimeters and a width in the range of 1 to 40 millimeters.

Abstract: A medical device lead includes a tubular conductive element disposed over a lead body. The tubular conductive element includes at least one segment having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect at least one electrical property, e.g., electrical impedance, of the segment. The segment may form a shocking conductor of the medical device lead. The tubular conductive element may alternatively include proximal, intermediate and distal segments each having one or more kerfs formed radially therethrough, where the one or more kerfs in each of the proximal and intermediate segments are configured so that these segments each have a higher electrical impedance than the distal segment. A layer of insulative material is disposed over the proximal and intermediate segments, so that the proximal and intermediate segments of the tubular conductive element are operable to filter electromagnetic energy from an external source.

Abstract: Insertion tools for medical applications. An illustrative example is an insertion tool for implanting a lead such as a subcutaneous defibrillation lead, which includes a handle at a proximal end, a catheter, and a distal end. A plurality of stylets having dottering tips are provided in the insertion tool. Reciprocating action of the dottering tips and/or stylets is imparted to dissect through subcutaneous tissue and create a tunnel for implantation of the lead.

Abstract: An illustrative anchoring mechanism is provided for attachment to an implantable subcutaneous lead to facilitate anchoring at the distal tip of the lead. The anchoring mechanism is attached to an opening in a distal portion of a subcutaneous lead prior to implantation. The anchoring mechanism may be designed to avoid covering the sensing electrode of the subcutaneous lead, to prevent interference with sensing. Use of such an apparatus may reduce the number of incisions needed to perform implantation.

Abstract: Various embodiments concern implanting a lead to directly stimulate the bundle of His. Various embodiments can include introducing a curve of an outer guide catheter into the right ventricle, extending a curve of an inner guide catheter from a lumen of the outer guide catheter, extending a fixation element on a distal tip of an anchor wire from a lumen the inner guide catheter, and anchoring the anchor wire to target tissue within the right ventricle, the target tissue along the septal wall and proximate the tricuspid valve and the bundle of His. A distal tip of an implantable lead with a lumen can then be advanced over the anchor wire to the target tissue as the anchor wire guides the distal tip of the lead to the target tissue.

Abstract: New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, substernally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.

Abstract: Methods and tool kits for implanting a lead subcutaneously. Examples include tool kits and methods for establishing first and second subcutaneous tunnels at an angle relative to one another to facilitate introduction of a lead to the subcutaneous space. In an example, a first insertion tool is used to establish a first subcutaneous tunnel, and a second insertion tool, with or without the use of a blunt dissector, sheath, guidewire, or steering mechanism, is used to initiate or form the second subcutaneous tunnel. Such methods and tool kits may reduce the number of incisions needed to implant a subcutaneous lead along a subcutaneous path having a curve therein.

Abstract: A medical device lead includes a tubular conductive element disposed over a lead body. The tubular conductive element includes at least one segment having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect at least one electrical property, e.g., electrical impedance, of the segment. The segment may form a shocking conductor of the medical device lead. The tubular conductive element may alternatively include proximal, intermediate and distal segments each having one or more kerfs formed radially therethrough, where the one or more kerfs in each of the proximal and intermediate segments are configured so that these segments each have a higher electrical impedance than the distal segment. A layer of insulative material is disposed over the proximal and intermediate segments, so that the proximal and intermediate segments of the tubular conductive element are operable to filter electromagnetic energy from an external source.

Abstract: A medical device lead includes a tubular conductive element disposed over a lead body. The tubular conductive element includes at least one segment having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect at least one electrical property, e.g., electrical impedance, of the segment. The segment may form a shocking conductor of the medical device lead. The tubular conductive element may alternatively include proximal, intermediate and distal segments each having one or more kerfs formed radially therethrough, where the one or more kerfs in each of the proximal and intermediate segments are configured so that these segments each have a higher electrical impedance than the distal segment. A layer of insulative material is disposed over the proximal and intermediate segments, so that the proximal and intermediate segments of the tubular conductive element are operable to filter electromagnetic energy from an external source.

Abstract: Various aspects of the present disclosure are directed toward methods, apparatuses, and systems that include an implantable medical device comprising an implantable lead, a suture sleeve having an interior surface defining a lumen of the suture sleeve that receives the implantable lead, and an engagement feature configured to non-removeably secure the suture sleeve to the implantable lead.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an implantable medical device. The implantable medical device may include an implantable pacing member having a housing and a lead input. A lead may be coupled to the lead input. The lead may be designed to extend along a pericardial space, epicardium, or both and engage a heart chamber. A passageway may be defined along a portion of the length of the lead.

Abstract: Devices, systems, and methods for implanting and testing multi-conductor electrical leads are disclosed. An illustrative implant tool for use with an implantable lead includes a main body, a plurality of spring contact members, and a knob mechanism. The main body of the implant tool includes a distal clamping mechanism with an opening adapted to frictionally receive a terminal boot of the implantable lead. The spring contact members are configured to provide an interface for connecting electrical connectors from a Pacing System Analyzer (PSA) or other testing device to the terminal contacts on the implantable lead. A knob mechanism coupled to the main body can be actuated to engage a terminal pin of the implantable lead, allowing an implanting physician to engage a fixation helix into body tissue by rotating the mechanism.