Abstract: An apparatus for neuromuscular electrical stimulation is provided. The apparatus may be a stimulation lead having an elongated member made up of at least one conductor and an insulative sheath surrounding at least a portion of the conductor. A distal portion of the elongated member may include one or more electrodes and at least one fixation element to secure the one or more electrodes in or adjacent to a desired anatomical site for providing stimulation thereto. The stimulation lead has a strain relief portion on the proximal side of the one or more electrodes, configured to reduce axial forces on the distal region of the elongated member, and the effects thereof, to reduce the risk of, or even prevent, displacement of the one or more electrodes and to accommodate localized flexural motion. The apparatus also may include at least one fixation element sized and configured to be deployed between muscle layers to maintain the electrode position at the stimulation site.

Abstract: A system of implanting electrode leads for restoring muscle function to the lumbar spine to treat low back pain is provided. The system provides efficient implantation of the leads, including the ability to verify deployment of anchoring mechanisms on the lead using an impedance assessment, such that the implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system.

Abstract: A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Abstract: Apparatus for neuromuscular electrical stimulation and methods for anchoring the same are provided. The apparatus may include an elongated member having one or more electrodes disposed at the distal region of the elongated member and at least one fixation element disposed at the distal region of the elongated member. The fixation element may be shaped and sized to be deployed between tissue layers, such as muscle layers, without damaging the tissue layers so as to secure the one or more electrodes in or adjacent to a desired anatomical site within a patient. An additional fixation element may be disposed at the distal region of the elongated member so that tissue, such as a muscle, may be sandwiched between the fixation elements without damaging the tissue.

Abstract: Apparatus and methods for tethering an electrode lead to an anatomical structure within a patient using a coupling member are provided. An anchor configured to be secured to the anatomical structure and an electrode lead suitable for neuromuscular stimulation of spinal muscles and/or nerves innervating one or more muscles that contribute to spine stability may be used. The electrode lead is configured to be coupled to the anchor via the coupling member by securing a first end of the coupling member to the electrode lead and securing a second end of the coupling member to an eyelet of the anchor to place the electrode lead at a desired anatomical site within the patient.

Abstract: A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

Abstract: Apparatus and methods for treating back pain are provided, in which an implantable stimulator is configured to communicate with an external control system, the implantable stimulator providing a neuromuscular electrical stimulation therapy designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability; the implantable stimulator further including one or more of a number of additional therapeutic modalities, including a module that provides analgesic stimulation; a module that monitors muscle performance and adjusts the muscle stimulation regime; and/or a module that provides longer term pain relief by selectively and repeatedly ablating nerve fibers. In an alternative embodiment, a standalone implantable RF ablation system is described.

Abstract: Implementing a subcutaneous medical electrode system involves positioning a number of electrode subsystems in relation to a heart so that noise cancellation provides an improved signal to noise ratio of the cardiac signal and/or to provide one electrode arrangement preferential for cardiac signals and another arrangement preferential for noise signals. One of the electrode subsystems so positioned may include one or more can electrodes located on a housing enclosing a medical device. The medical device may be configured to provide therapeutic, diagnostic, or monitoring functions, including, for example, cardiac arrhythmia therapy.

Abstract: A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.

Abstract: The present invention is a myocardial lead attachment system for securing a lead within the myocardium. The attachment system includes an anchor configured to engage the heart, a tether coupled to the anchor and a lead body. The lead body has a proximal end, a distal end, a lumen for accepting the tether and a lock housing in the lumen. A lock structure is on the tether and mates with the lock housing and restrains motion of the lead with respect to the tether in either of a proximal or a distal direction.

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: A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

Abstract: The present invention is a myocardial lead attachment system for securing a distal end of a cardiac lead within a myocardium of a patient's heart and anchoring against an epicardium of the patient's heart. The system includes an anchor configured to advance in a first orientation and anchor against an epicardial surface in a second orientation and a tether having a proximal end and a distal end. The anchor is coupled to the distal end of the tether. The system includes a cardiac lead having a lead body, a lumen extending through the lead body, a conductive member, a proximal end, a distal end, and an electrode configured for stimulating the myocardium located at the distal end. The lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor during implantation. The system includes a fixation mechanism at the distal end of the cardiac lead.

Abstract: The present invention is a myocardial lead attachment system and method for securing a distal end of a lead within the myocardium of a patient's heart. The system includes an anchor, a tether coupled at a distal end to the anchor and a lead body. The lead body has a proximal end, a distal end, and a lumen extending therethrough for receiving the tether. A fixation mechanism is at the distal end of the lead body, and is adapted to collapse to a first configuration during implantation and deploy to a second configuration after implantation.

Abstract: A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

Abstract: A lead having an extendable and retractable fixation mechanism has a rotating terminal pin at the terminal end which rotates the fixation mechanism at the distal end. As the terminal pin is rotated, the fixation mechanism is extended or retracted from the distal end of the lead. A threaded collar allows for the fixation mechanism to smoothly extend and retract from the lead, and allows for a 1:1 turn ratio between the terminal pin and the fixation mechanism. A fluoroscopic ring disposed at the distal end of the lead provides information during the implantation process.

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: Implementing a subcutaneous medical electrode system involves positioning a number of electrode subsystems in relation to a heart so that noise cancellation provides an improved signal to noise ratio of the cardiac signal and/or to provide one electrode arrangement preferential for cardiac signals and another arrangement preferential for noise signals. One of the electrode subsystems so positioned may include one or more can electrodes located on a housing enclosing a medical device. The medical device may be configured to provide therapeutic, diagnostic, or monitoring functions, including, for example, cardiac arrhythmia therapy.

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.