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: 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: Implantable leads of a cardiac stimulus system are disclosed, as well as methods for implanting leads of a cardiac stimulus system. The lead may be comprised of a proximal portion having a coupler for coupling to an implantable pulse generator, an intermediate portion comprising a plurality of electrodes disposed thereon, and a distal portion. The intermediate portion may have a first diameter and the distal portion may have a second diameter. The distal portion may also have an attachment feature for attaching to a lead pulling tool for delivery to an ITV and an intercostal vein. Methods may include pulling a lead from a first position to a second position within the vasculature, exiting the vasculature at the second location, and attaching a portion of the lead that exits the vasculature to an electrode or implantable device for use with the lead.

Abstract: Implantation of a cardiac stimulus system 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. A positioning mechanism may be advanced to the ITV, a location of the positioning mechanism may then be obtained, and an external access may then be established. Inferior external access may be accomplished inferior to the lower rib margin via the superior epigastric or musculophrenic vein. Intercostal external access may be accomplished via an intercostal vein between two ribs. A lead may then be attached to the positioning mechanism and drawn into the ITV.

Abstract: Implantation of a cardiac stimulus system using an illuminating catheter system, and devices for such implantation. Multiple catheter systems for allowing for selective visualization of the internal thoracic vasculature are discussed and disclosed. A multiple lumen catheter may be used to selectively direct a contrast agent to a desired portion of the thoracic vasculature which may include the internal thoracic vein(s) and/or one or more intercostal veins.

Abstract: A leadless pacing device may include a power supply for providing a power supply voltage, a housing having a first end and a second end with a side extending between the first end and the second end, and a set of electrodes supported by the housing and in communication with the power supply. When leadless pacing device is disposed within a coronary sinus of a patient's heart, the housing may facilitate blood flow across the housing. The housing may include fixing members extending radially outward from the side of the housing to engage a wall of the coronary sinus and expand the coronary sinus to allow blood to flow past the housing. In some cases, the housing may have a recess along a length thereof that allows blood to flow past the housing. The recess may include a groove, a flat feature, or other feature.

Abstract: Implantation of a cardiac stimulus system using the intercostal veins. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed by entering the brachiocephalic vein from a jugular, subclavian, or other vein, and then accessing the internal thoracic vein, traversing a portion of the internal thoracic vein and then accessing an intercostal vein therefrom. Inferior access may be accomplished inferior to the lower rib margin via the superior epigastric vein, advancing superiorly into the internal thoracic vein and then accessing an intercostal vein therefrom. Intercostal access may include creating an opening in an intercostal space between two ribs and advancing a needle using ultrasound guidance to enter the intercostal vein directly.

Abstract: Methods for implanting leads in the internal thoracic vein (ITV) of a patient may include first screening the patient to determine if various screening criteria are met. The screening criteria may include rib spacing, ITV location, and ITV diameter. When a predetermined parameter of at least one of the screening criteria is met, the implantation of one or more leads extending into the ITV and to a pulse generator are completed.

Abstract: An IMD may include a housing with a controller and a power supply disposed within the housing. A distal electrode may be supported by a distal electrode support that biases the distal electrode toward an extended position in which the distal electrode extends distally from the distal end of the housing and allows the distal electrode to move proximally relative to the extended position in response to an axial force applied to the distal electrode in the proximal direction. In some cases, the distal electrode support may include a tissue ingrowth inhibiting outer sleeve that extends along the length of the distal electrode support and is configured to shorten when the distal electrode moves proximally relative to the extended position and to lengthen when the distal electrode moves back distally toward the extended position in order to accommodate movement of the distal electrode.

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: Implantation of a cardiac stimulus system using the ITV. Access to the ITV may be performed using the intercostal vein as an access point, and entering the ITV through an ostium therebetween. The intercostal vein may be located on a costal groove on an inferior portion of a rib. Advancement from the intercostal vein to the ITV may then be performed in a superior direction, an inferior direction, or both.

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: Cardiac therapy devices in the form of pacemakers and/or defibrillators including one or more leads with electrodes implanted in a vein in a posterior position in combination with one or more leads with electrodes implanted in an anterior position. The posterior position may be chosen from one or more of the azygos, hemiazygos, accessory hemiazygos, or posterior intercostal veins. The anterior position may be chosen from the internal thoracic vein, an anterior intercostal vein, or an anterior subcutaneous location. In other examples, sensors are placed for use by a cardiac monitoring or therapy system in one or more of the internal thoracic vein, the azygos vein, the hemiazygos vein, the accessory hemiazygos vein, and/or an anterior or posterior intercostal vein.

Abstract: Implantable medical devices (IMD) such as a cardiac pacemakers may include a sensor and electrodes. In some cases, the IMD may include electronics to use the sensor to determine the heart rate of a patient's heart. The electronics may use the electrodes to deliver pacing pulses to the heart at a first energy level if the heart rate is below a threshold and pace the heart at an enhanced energy level if the heart rate is above the threshold.

Abstract: A lead for use with cardiac stimulus device with at least two electrodes positioned at a single longitudinal location is provided. The electrodes may include a shocking coil electrode and a sensing and/or pacing ring electrode and may be separated by an insulating element. The at least two electrically insulated electrodes may be electrically isolated and serve separate purposes in the device.

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: Cardiac therapy devices in the form of pacemakers and/or defibrillators including one or more leads with electrodes implanted in a vein in a posterior position in combination with one or more leads with electrodes implanted in an anterior position. The posterior position may be chosen from one or more of the azygos, hemiazygos, accessory hemiazygos, or posterior intercostal veins. The anterior position may be chosen from the internal thoracic vein, an anterior intercostal vein, or an anterior subcutaneous location. In other examples, sensors are placed for use by a cardiac monitoring or therapy system in one or more of the internal thoracic vein, the azygos vein, the hemiazygos vein, the accessory hemiazygos vein, and/or an anterior or posterior intercostal vein.

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 terminal tool includes a main body, an electrical connector body, and an electrical connector. The main body includes a distal clamping section and a shaft. The shaft includes a window and a first lumen extending through the shaft for receiving a terminal end of an implantable lead. The electrical connector body includes a second lumen and is independently rotatable with respect to the main body. The shaft at least partially extends through the second lumen. The electrical connector is coupled to the electrical connector body and extends at least partially through the window of the shaft.

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.