Abstract: Systems, methods, and devices to facilitate insertion of certain leads with electrode(s) into patients are described. Leads can be implanted to work in conjunction with a cardiac pacemaker or cardiac defibrillator. A lead for cardiac therapy may be inserted into an intercostal space associated with the cardiac notch of a patient. Devices for delivery may include, for example, a delivery system coupled with an electrical lead and having a handle, a component advancer and insertion tips. The handle is configured to be actuated by an operator and the component advancer is configured to advance an electrical lead into the patient. The insertion tips can be configured to close around the electrical lead within the component advancer, to push through biological tissue, and to open to enable the lead to advance into the patient. The electrical lead can also be maintained in a particular orientation during the advancement into the patient.

Abstract: Devices and methods for single therapy pulse (STP) therapy for tacharrythmia are disclosed. The STP therapy can be delivered from a far-field position to allow a “global” capture approach to pacing. Due to the global capture in STP, a series of pulses, which is indicative of conventional anti-tachycardia pacing (ATP) delivered by transvenous systems, becomes unnecessary. One to four pulses at most are needed for STP, and after delivery of the one to four pulses, therapy delivery can be interrupted to determine whether the previously delivered therapy has been successful.

Abstract: Systems, methods and devices to facilitate insertion of a lead for cardiac therapy into an intercostal space associated with the cardiac notch of a patient are described including devices, methods and medical procedure templates to facilitate insertion proximate to a lateral margin of the patient's sternum.

Abstract: Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In some examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. Several examples emphasize the use of morphology analysis using correlation to static templates and/or inter-event correlation analysis.

Abstract: Methods, systems, and devices for signal analysis in an implantable cardiac device such as an implantable cardioverter defibrillator. In illustrative examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. Analysis of the apparent width of detected events is used to determine whether overdetection is occurring. If overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data.

Abstract: Methods and devices for sensing vector analysis in an implantable cardiac stimulus system. In an illustrative example, a first sensing vector is analyzed to determine whether it is suitable, within given threshold conditions, for use in cardiac event detection and analysis. If so, the first vector may be selected for detection and analysis. Otherwise, one or more additional vectors are analyzed. A detailed example illustrates methods for analyzing sensing vectors by the use of a scoring system. Devices adapted to perform these methods are also discussed, including implantable medical devices adapted to perform these methods, and systems comprising implantable medical devices and programmers adapted to communicate with implantable medical devices, the systems also being adapted to perform these methods. Another example includes a programmer configured to perform these methods including certain steps of directing operation of an associated implanted or implantable medical device.

Abstract: A cardiac pacing system that includes an implantable pulse generator and electrical leads that include a lead body portion having a distal end and a proximal end, a connector configured to electrically connect the proximal end of the lead body to the pulse generator, and at least one electrode disposed at the distal end of the lead body for delivering electrical stimulation to a patient's heart, wherein the distal end of the lead body is configured to terminate within the mediastinum of the thoracic cavity of the patient, proximate to the heart.

Abstract: Systems, methods and devices for delivering stimulating energy with a lead having a directional electrode are disclosed. The lead includes a directional electrode having an electrically active portion configured to emanate stimulating energy from an exposed portion of the directional electrode. The lead also has an electrically insulating portion around at least part of the circumference of the lead. The electrically insulating portion is configured to insulate surrounding muscle and/or tissue from the stimulating energy when the lead is implanted in the patient.

Abstract: A cardiac pacing system having a pulse generator for generating therapeutic electric pulses, a lead electrically coupled with the pulse generator having an electrode, a first sensor configured to monitor a physiological characteristic of a patient, a second sensor configured to monitor a second physiological characteristic of a patient and a controller. The controller can determine a pacing vector based on variables including a signal received from the second sensor, and cause the pulse generator to deliver the therapeutic electrical pulses according to the determined pacing vector. The controller can also modify pacing characteristics based on variables including a signal received from the second sensor.

Abstract: A cardiac pacing system that includes an implantable pulse generator and electrical leads that include a lead body portion having a distal end and a proximal end, a connector configured to electrically connect the proximal end of the lead body to the pulse generator, and at least one electrode disposed at the distal end of the lead body for delivering electrical stimulation to a patient's heart, wherein the distal end of the lead body is configured to terminate within the mediastinum of the thoracic cavity of the patient, proximate to the heart.

Abstract: A cardiac defibrillation system that includes a pulse generator to generate therapeutic electrical pulses and at least one lead inserted through an intercostal space in the region of a cardiac notch of the left lung of a patient, the lead having a distal end configured to transmit the therapeutic electrical pulses generated by the pulse generator to defibrillate the heart of the patient.

Abstract: Devices and methods for single therapy pulse (STP) therapy for tacharrythmia are disclosed. The STP therapy can be delivered from a far-field position to allow a “global” capture approach to pacing. Due to the global capture in STP, a series of pulses, which is indicative of conventional anti-tachycardia pacing (ATP) delivered by transvenous systems, becomes unnecessary. One to four pulses at most are needed for STP, and after delivery of the one to four pulses, therapy delivery can be interrupted to determine whether the previously delivered therapy has been successful.

Abstract: Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In illustrative examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. New methods for organizing the use of morphology and rate analysis in an overall architecture for rhythm classification and cardiac signal analysis are also discussed.

Abstract: A cardiac pacing system that includes a pulse generator to generate therapeutic electrical pulses and at least one lead inserted through an intercostal space in the region of a cardiac notch of the left lung of a patient, the lead having a distal end configured to transmit the therapeutic electrical pulses generated by the pulse generator to pace the heart of the patient.

Abstract: A cardiac pacing system having a pulse generator for generating therapeutic electric pulses, a lead electrically coupled with the pulse generator having an electrode, a first sensor configured to monitor a physiological characteristic of a patient, a second sensor configured to monitor a second physiological characteristic of a patient and a controller. The controller can determine a pacing vector based on variables including a signal received from the second sensor, and cause the pulse generator to deliver the therapeutic electrical pulses according to the determined pacing vector. The controller can also modify pacing characteristics based on variables including a signal received from the second sensor.

Abstract: A delivery device for installing a medical device in a patient comprising a body portion having a proximal end and a distal end, the distal end having a chisel shaped tip, a receptacle disposed in the distal end of the body portion for receiving a medical device for implanting in the patient, a handle disposed at the proximal end of the body portion for facilitating advancement of the proximal end of the body portion into the patient.

Abstract: Devices and methods for single therapy pulse (STP) therapy for tacharrythmia are disclosed. The STP therapy can be delivered from a far-field position to allow a “global” capture approach to pacing. Due to the global capture in STP, a series of pulses, which is indicative of conventional anti-tachycardia pacing (ATP) delivered by transvenous systems, becomes unnecessary. One to four pulses at most are needed for STP, and after delivery of the one to four pulses, therapy delivery can be interrupted to determine whether the previously delivered therapy has been successful.

Abstract: Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In illustrative examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. New methods for organizing the use of morphology and rate analysis in an overall architecture for rhythm classification and cardiac signal analysis are also discussed.

Abstract: A delivery device for installing a medical device in a patient comprising a body portion having a proximal end and a distal end, the distal end having a chisel shaped tip, a receptacle disposed in the distal end of the body portion for receiving a medical device for implanting in the patient, a handle disposed at the proximal end of the body portion for facilitating advancement of the proximal end of the body portion into the patient.

Abstract: Methods and devices for addressing difficulty with cardiac event sensing that can arise if the starting point of the cardiac cycle is not well aligned to the intended starting point of a detection profile used for sensing. As an improvement, illustrative methods and devices provide an addition to cardiac sensing operations by adjusting the starting point of a detection profile to align with a desired point in the cardiac signal.