Abstract: Cardiac monitoring and/or stimulation methods and systems provide monitoring, defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, separates a signal using a source separation algorithm, and identifies a cardiac signal using a selected vector. The signal processor may iteratively separate signals from the plurality of composite signals until the cardiac signal is identified. The selected vector may be updated if desired or necessary. A method of signal separation involves detecting a plurality of composite signals at a plurality of locations, separating a signal using source separation, and selecting a vector that provides a cardiac signal. The separation may include a principal component analysis and/or an independent component analysis.

Abstract: Cardiac monitoring and/or stimulation methods and systems provide monitoring, defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, separates a signal using a source separation algorithm, and identifies a cardiac signal using a selected vector. The signal processor may iteratively separate signals from the plurality of composite signals until the cardiac signal is identified. The selected vector may be updated if desired or necessary. A method of signal separation involves detecting a plurality of composite signals at a plurality of locations, separating a signal using source separation, and selecting a vector that provides a cardiac signal. The separation may include a principal component analysis and/or an independent component analysis.

Abstract: An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: Subcutaneous leads that incorporate active fixation elements including, for example, helical coils, provide for fixation of cardiac lead components within a patient. An implantable lead includes a lead body with a supported electrode configured for subcutaneous non-intrathoracic placement within a patient. A fixation element is provided on the implantable lead and configured to actively secure one or both of the subcutaneous electrode and the lead body in tissue. A delivery apparatus comprising a sheath may be employed that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location. Lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead supporting an electrode, advancing the lead through the sheath, actively fixing the lead to tissue, and thereafter removing the sheath from the patient.

Abstract: Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.

Abstract: Subcutaneous systems and leads may be fixed in tissue after placement by use of one or more expanding fixation elements. An expanding fixation element is provided on an implantable lead and configured to secure one or both of a subcutaneous electrode and the lead body within subcutaneous non-intrathoracic tissue. A delivery apparatus comprising a sheath may be included that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient. A method of lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead comprising a lead body and an electrode, and advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location. The method further involves fixing the lead to subcutaneous non-intrathoracic tissue using an expanding fixation element and thereafter removing the sheath from the patient.

Abstract: Cardiac monitoring and/or stimulation methods and systems provide monitoring, defibrillation and/or pacing therapies. A signal processor receives a plurality of composite signals associated with a plurality of sources, separates a signal using a source separation algorithm, and identifies a cardiac signal using a selected vector. The signal processor may iteratively separate signals from the plurality of composite signals until the cardiac signal is identified. The selected vector may be updated if desired or necessary. A method of signal separation involves detecting a plurality of composite signals at a plurality of locations, separating a signal using source separation, and selecting a vector that provides a cardiac signal. The separation may include a principal component analysis and/or an independent component analysis.

Abstract: Implantable subcutaneous devices and methods incorporating a lead and/or electrode for cardiac monitoring and intervention, the lead employing chronic fixation elements including, for example, ridges, grooves, surface roughness, porosity, combined with acute fixation elements such as, for example, a suture site. A method of implanting subcutaneous leads may involve providing a lead comprising a lead body, an electrode, an acute fixation element, and one or more chronic fixation elements, and securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve: introducing a sheath into a subcutaneous non-intrathoracic body location of a patient; providing a lead comprising a lead body and an electrode; advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location; fixing the lead to subcutaneous non-intrathoracic tissue; and removing the sheath from the patient.

Abstract: An implantable subcutaneous device and method employ a lead and/or electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode supported by the lead body, and a pharmacological agent provided on the implantable lead body and/or an inactive can portion. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: Subcutaneous leads that incorporate active fixation elements including, for example, helical coils, provide for fixation of cardiac lead components within a patient. An implantable lead includes a lead body with a supported electrode configured for subcutaneous non-intrathoracic placement within a patient. A fixation element is provided on the implantable lead and configured to actively secure one or both of the subcutaneous electrode and the lead body in tissue. A delivery apparatus comprising a sheath may be employed that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location. Lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead supporting an electrode, advancing the lead through the sheath, actively fixing the lead to tissue, and thereafter removing the sheath from the patient.

Abstract: Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.

Abstract: An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: Subcutaneous systems and leads may be fixed in tissue after placement by use of one or more expanding fixation elements. An expanding fixation element is provided on an implantable lead and configured to secure one or both of a subcutaneous electrode and the lead body within subcutaneous non-intrathoracic tissue. A delivery apparatus comprising a sheath may be included that is configured to introduce the lead to a desired subcutaneous non-intrathoracic location within the patient. A method of lead delivery typically involves introducing a sheath into a subcutaneous non-intrathoracic body location of a patient, providing a lead comprising a lead body and an electrode, and advancing the lead through the sheath and to the subcutaneous non-intrathoracic body location. The method further involves fixing the lead to subcutaneous non-intrathoracic tissue using an expanding fixation element and thereafter removing the sheath from the patient.

Abstract: An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.