Abstract: Implantable medical device systems and methods of use including an implantable first medical device having a lead with a transducer thereon and an implantable second medical device having a receiver for receiving energy emitted by the transducer. The lead may be placed in an internal thoracic vein, and other locations may be used as well. The implantable second medical device may be placed in or on the heart or an associated blood vessel.

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: 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: 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: 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 retention device for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a configured to receive the lead of the IMD. The retention device may also include securing mechanisms coupled to the elongate body and configured to push against tissue of a patient. The securing mechanisms may also include linking elements coupled to the elongate body and a portion of the securing mechanisms.

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: 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: Retention devices for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a hollow lumen configured to receive a lead of the IMD and an outer surface configured to receive a suture. The retention device may also include a securing mechanism configured to push against tissue of a patient.

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: Retainer devices and methods are configured for securing medical devices subcutaneously in a patient. The retainer device may include first and second arms connected by a bridge, the retainer clip configured to move between a first orientation in which lower surfaces of the first and second arms face each other, and a second orientation in which the first and second arms extend laterally from opposite sides of the bridge, wherein the clip is biased in the second orientation. Another example includes a coil and delivery device in which the delivery device holds the coil in a general straight configuration until release; when released the coil wraps about a medical device and holds the device to the subcutaneous tissue.

Abstract: A catheter for delivering a medical electrical lead to a bundle of His from within a right atrium of a heart. The catheter includes a straight portion and a hook portion projecting from a distal end of the straight portion. The hook portion includes a first curved portion, a second curved portion, and a third curved portion. The straight portion and the first curved portion define a plane. The second curved portion extends from a distal end of the first curved portion. The second curved portion curves away from the plane. The third curved portion extends from a distal end of the second curved portion. The third curved portion curves toward the plane. The catheter forms a lumen extending from a proximal end of the straight portion to an opening at a distal end of the third curved portion.

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: 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 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: Methods and kits for subcutaneous defibrillator implantation. In various examples, two introducer tools each having a sheath are used during an implantation procedure to obviate the need for pulling a lead using a suture. The elimination of the suture-based pulling steps may reduce procedure time. A kit having two introducer tool and corresponding sheaths is also disclosed.

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: Tools adapted to allow a fixation device to be applied near the distal end of an implantable lead, and methods for using such tools. Preparing the lead for implantation may be performed by placing a tool over a distal tip of the lead, moving a fixation device from the tool to the lead, and placing the fixation device the lead.

Abstract: Retention devices for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a bore configured to receive and substantially surround an implantable lead of the IMD and an outer surface configured to receive a suture. The retention device may also include a securing mechanism configured to push against tissue of the patient.

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 tunneling tool and lead assembly are advanced simultaneously into the subcutaneous space. The tunneling tool may include a curved region configured to transition the tool from the first subcutaneous tunnel to the second subcutaneous tunnel with the use of a single incision.