Abstract: Microelectrode assemblies and related methods are disclosed for bio-stimulating and/or bio-sensing a target tissue. The assemblies can include a two-side substrate, an array of microelectrodes, each of the microelectrodes including a nano-wire embedded within the substrate and extending from a proximal end to a distal end and through the substrate, each nano-wire having a diameter preferably less than 1 ?m. The substrate can include portions made of nano-porous material(s) through which the microelectrodes pass. The substrate with the embedded nano-wires can effectively be fluid impermeable. The proximal ends of the nano-wires can be adapted to be connected to an electronic device and the distal ends are adapted to be disposed in a biological environment for bio-stimulating a target tissue and/or bio-sensing activities of the target tissue. Suitable alloys such as platinum, platinum-iridium, and/or other noble-metal-alloyed compositions can be used for the nano-wires.

Abstract: Implantable hermetically sealed structures and methods for making the same. Devices, systems and kits including the hermetically sealed structures, as well as methods of using such devices and systems are included.

Abstract: To provide radio-frequency (RF) bandstop filtering within an implantable lead for use in reducing lead heating during magnetic resonance imaging (MRI) procedures, parallel inductive-capacitive (LC) filters are provided within the lead. In one example, the ring electrode of the lead is configured to function as one of the capacitive elements of the parallel LC filter to help provide LC bandstop filtering along the ring conductor of the lead. In another example, capacitive plates are provided that sandwich an inductor mounted near the tip of the lead to provide parallel LC bandstop filtering along the tip conductor of the lead.

Abstract: An implantable medical device that includes a lead body extending from a proximal end to a distal end, a plurality of conductors extending between the proximal end and the distal end of the lead body, and an insulative layer formed of a hydrolytically stable polyimide material surrounding the plurality of conductors. In one embodiment, the hydrolytically stable polyimide material is an SI polyimide material.

Abstract: Various aspects of the present subject matter provide devices and methods to treat AV-conducted ventricular tachyarrhythmia (AVCVT). According to various embodiments of the method, an AVCVT is sensed, an IVC-LA fat pad is stimulated when the AVCVT is sensed to block AV conduction, and bradycardia support pacing is provided while the IVC-LA fat pad is stimulated. Other aspects and embodiments are provided herein.

Abstract: Medical devices, methods of manufacturing medical devices, and systems comprising medical devices are provided. The device comprises a shaft having a major lumen sized to receive a second medical device and an electrode mounted thereon. The shaft includes an inner liner and outer layer. The method of manufacture includes forming a shaft by forming an inner liner and an outer layer by covering the inner liner with a polymeric material. The method further includes mounting an electrode onto the shaft of the device, and then heating and cooling the shaft. The system comprises a medical device having a shaft and an electrode mounted thereon. The shaft has a major lumen sized to receive another device. The system further comprises an electronic control unit configured to receive signals from the electrode and to determine a position of the electrode and/or monitor electrophysiological data.

Abstract: Some embodiments of an electrical stimulation system employ wireless electrode assemblies to provide pacing therapy, defibrillation therapy, or other stimulation therapy. In certain embodiments, the wireless electrode assemblies may include a guide wire channel so that each electrode assembly can be advanced over a guide wire instrument through the endocardium. For example, a distal tip portion of a guide wire instrument can penetrate through the endocardium and into the myocardial wall of a heart chamber, and the electrode assembly may then be advanced over the guide wire and into the heart chamber wall. In such circumstances, the guide wire instrument (and other portions of the delivery system) can be retracted from the heart chamber wall, thereby leaving the electrode assembly embedded in the heart tissue.

Abstract: Electrotherapeutic implant for stimulation of body tissue, comprising at least two electrode poles (14) which are connected to electric feeder lines, a demodulation unit (22), at least one electric feeder line (20), which is designed as an antenna and contacts the demodulation unit (22), wherein the implant (10) is fabricated from one piece, can be affixed (16) at the treatment site and is equipped with a biocompatible insulation, whereby the components of the implant (10) are designed so that a therapeutic energy which can be injected from the outside over the antenna (20) during the treatment is delivered to the therapeutic target region without intermediate storage.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: This disclosure relates to fault tolerant instantiations of a cardiac therapy delivery device such as an implantable cardiac stimulator (e.g., an implantable pulse generator, IPG, and/or an implantable cardioverter-defibrillator, ICD) coupled to an implantable physiologic sensor (IPS). According to the disclosure delivery of cardiac pacing and/or cardioversion-defibrillator therapy delivery can cause errors in output signals from an IPS. Resolution of such errors involves selectively energizing (or disconnecting the output signal from) the IPS during pacing and/or defibrillation therapy delivery. Programmable signal “blanking” in lieu of or in addition to the foregoing also improves the integrity of the output signal (i.e., continuously energize the IPS and ignore parts of the output signal). An ICD having a transient weakness in an insulated conductor used for the IPS signal can likewise have the IPS de-energized and/or blank the IPS output signal during high voltage therapy delivery.

Abstract: An improved pacemaker lead including a lead body supporting at least one flexible conductor element that provides an electrical signal path between a proximal connector element and a distal electrode. The lead body includes an insulating structure that protects the flexible conductor element(s) wherein the insulating structure is realized from a polymer blend of a thermoplastic polyurethane elastomer and an isobutylene block copolymer. The mole fraction of the isobutylene block copolymer of the polymer blend is in the range of 2-15% (most preferably on the order of 10%). The polymer blend of the insulating structure has a maximum tensile strength in the range of 20-40 MPa (most preferably in a range of 25-35 MPa). In the preferred embodiment, the hardness of the polymer blend can be characterized by a Shore hardness in a range of 70-80 A.

Abstract: An implanted electrical signal generator delivers a novel exogenous electrical signal to a vagus nerve of a patient. The vagus nerve conducts action potentials originating in the heart and lungs to various structures of the brain, thereby eliciting a vagal evoked potential in those structures. The exogenous electrical signal simulates and/or augments the endogenous afferent activity originating from the heart and/or lungs of the patient, thereby enhancing the vagal evoked potential in the various structures of the brain. The exogenous electrical signal includes a series of electrical pulses organized or patterned into a series of microbursts including 2 to 20 pulses each. No pulses are sent between the microbursts. Each of the microbursts may be synchronized with the QRS wave portion of an ECG. The enhanced vagal evoked potential in the various structures of the brain may be used to treat various medical conditions including epilepsy and depression.

Abstract: A method for producing increased resistance to biodegradability is provided for biomedical devices subject to in vivo implantation. Among the steps required to produce such resistance are the application of a thermoplastic polyurethane coating to the device to provide a coating, and the subsequent crosslinking of the thermoplastic polyurethane coating through the application of radiation of a sufficient intensity and duration to convert said thermoplastic polyurethane coating to a thermoset coating possessing the attribute of increased biostability.

Abstract: A medical device and method for determining a parameter for delivery of a predetermined pacing therapy that includes a plurality of electrodes to deliver a pacing therapy, including the predetermined pacing therapy, and a control unit to control the timing of the delivery of the pacing therapy, including the predetermined pacing therapy, by the electrodes. A processor generates a first template in response to the pacing therapy being delivered to only one of a right ventricle and a left ventricle, and a second template in response to the pacing therapy being delivered to only the other of the right ventricle and the left ventricle, and determines the parameter in response to a comparing of subsequently delivered pacing therapy to the first template and the second template.

Abstract: A medical lead system includes at least one bandstop filter for attenuating current flow through the lead across a range of frequencies. The bandstop filter has an overall circuit Q wherein the resultant 3 dB bandwidth is at least 10 kHz. The values of capacitance and inductance of the bandstop filter are selected such that the bandstop filter is resonant at a selected center frequency or range of frequencies. Preferably, the bandstop filter has an overall circuit Q wherein the resultant 10 dB bandwidth is at least 10 kHz. Such bandstop filters are backwards compatible with known implantable deployment systems and extraction systems.

Abstract: A medical device includes a pulse generator and an electrode configured to contact tissue in a body vessel. The medical device includes a lead that includes a lead connector. The lead connector connects a pulse generator with an electrode via a conductive path. An electrode switch is electrically connected between the lead conductor and the electrode. The electrode switch includes an open state preventing the conductive path between the lead and the electrode. The electrode switch includes a closed state establishing the conductive path between the lead and the electrode when a voltage is applied across the electrode switch that exceeds a threshold voltage. The electrode switch in the open state electrically shields the electrode from electromagnetic radiation and induced voltages during magnetic resonance imaging.

Abstract: A subcutaneous implantable device is provided that includes a defibrillation electrode disposed along a portion of a lead, and a lead tip connected to the lead. The lead tip includes a trailing end coupled to a distal end of the lead, and first and second non-parallel sides extending from the trailing end that converge to a leading end that is configured to wedge between tissue layers as the lead is advanced subcutaneously.

Abstract: An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one shape memory polymer portion that has a first configuration and a second configuration, wherein the second configuration is obtained upon exposure of the shape memory polymer portion to a transition stimulus, and wherein the second configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems and kits as well as methods of utilizing the leads of the invention are also included.

Abstract: The disclosure relates in some aspects to an implantable pressure sensor and a method of measuring pressure. In some embodiments pressure may be measured through the use of an implantable lead incorporating one or more pressure sensors. In some aspects a pressure sensor is implemented in a micro-electromechanical system (“MEMS”) that employs direct mechanical sensing. A biocompatible material is attached to one or more portions of the MEMS sensor to facilitate implant in a body of a patient. The MEMS sensor may thus be incorporated into an implantable lead for measuring blood pressure in, for example, one or more chambers of the patient's heart.

Abstract: A method of identifying the fossa ovalis in a patient by positioning one or more electrodes against the tissue of the interatrial septum of the patient and acquiring unipolar and/or bipolar electrograms of the tissue of the interatrial septum while moving the electrodes to a plurality of positions against the tissue of the interatrial septum. The fossa ovalis is identified on the basis of unipolar voltage reduction, signal fractionation, broadened signal, reduced signal slew rate, reduced local myocardial impedance, increased phase angle and/or increased pacing threshold. An apparatus for identifying the fossa ovalis is also provided.

Abstract: Lumen-traveling biological interface devices and associated methods and systems are described. Lumen-traveling biological interface devices capable of traveling within a body lumen may include a propelling mechanism to produce movement of the lumen-traveling device within the lumen, electrodes or other electromagnetic transducers for detecting biological signals and electrodes, coils or other electromagnetic transducers for delivering electromagnetic stimuli to stimulus responsive tissues. Lumen-traveling biological interface devices may also include additional components such as sensors, an active portion, and/or control circuitry.

Abstract: A bandstop filter includes a capacitance in parallel with an inductance and is placed in series with the implantable lead of an active implantable medical device, wherein values of capacitance and inductance are selected such that the bandstop filter attenuates RF current flow at a selected center MRI RF pulsed frequency or across a range of frequencies. The Qi of the inductor and the Qc of the capacitor are controlled to reduce the overall Q of the bandstop filter to attenuate current flow through the implantable lead along a range of selected frequencies. In a preferred form, the bandstop filter is integrated into a Tip and/or Ring electrode for the active implantable medical device.

Abstract: A pacemaker includes a pulse generator, a conduction line, and a pacemaker electrode. The pacemaker electrode includes a body and an insulation layer. The body includes at least one carbon nanotube yarn. The carbon nanotube yarn includes a number of carbon nanotubes. The carbon nanotubes are interconnected along one axis of the body by van der Waals force. The insulation layer covers an outer surface of the body.

Abstract: A structure of electrically connecting a snap electrode for medical purposes is easily attached/detached to/from various monitoring pads attached to a human body to measure electrocardiogram (ECG), electromyogram (EMG), brain wave and nervous system signals and electrically connected to medical equipment, to an electric wire using a pressing method instead of welding. The connecting structure of a snap electrode and an electric wire includes a body having a convex portion, which is formed on the top of the body and has a groove formed on the circumference thereof, in which a combining part is fitted, and the combining protrusion having a ring shape and including a predetermined number of elastic fixing pieces protruded from the inner side thereof and a pair of first pressing pieces protruded from one side thereof and combined with an electric wire. A combining protrusion of a pad is inserted into the body.

Abstract: A guide catheter includes an outer guide having an open lumen and a longitudinal pre-stress line extending between a distal end and a proximal end of the outer guide. The outer guide has a longitudinal stiffness that facilitates transmission of forces and prevention of kinking during steering of the outer guide within cardiac vasculature and structures. An inner guide has an open lumen and is movably displaceable within the open lumen of the outer guide. At least a distal end of the outer guide and inner guide are dimensioned for passage into the patient's coronary sinus. A guide handle is connected to the proximal end of the outer guide and includes a longitudinal pre-stress line separable into at least two sections such that guide handle separation splits the outer guide along the longitudinal pre-stress line at the proximal end of the outer guide.

Abstract: The present invention reduces patient risks associated with RF-induced thermogenic tissue damage and with pulsed gradient-field-induced arrhythmias by using a defibrillator lead having a self-healing dielectric material that prevents induced voltages from MRI equipment from damaging an ICD or causing unintended defibrillation shocks to a patient. Another aspect of the present invention utilizes a sliding contact arrangement to prevent induced voltages from MRI equipment from being electrically coupled to an ICD thereby reducing patient risks associated with RF-induced thermogenic tissue damage and with pulsed gradient-field-induced arrhythmias.

Abstract: An aspect of the present subject relates to an implantable medical system. An embodiment of the system includes a baroreflex stimulator, a myocardial infarction detector, and a controller. The baroreflex stimulator applies a baroreflex stimulation signal through an electrode. The myocardial infarction detector detects an event indicative of myocardial infarction. The controller is connected to the baroreflex stimulator and to the myocardial infarction detector, and is adapted to apply a baroreflex therapy in response to a detected event indicative of myocardial infarction. Other aspects are provided herein.

Abstract: The present disclosure describes intravascular systems that may be used for a variety of functions. The elements of the disclosed systems include at least one device body implanted within the vasculature. Electrodes on a lead and/or on the device body itself are used to direct electrical energy to neurological targets. These systems may additionally include one or more fluid reservoirs housing drugs or other agents to be delivered to tissue.

Abstract: An interactive representation of electrostimulation electrodes or vectors can be provided, such as for configuring combinations of electrostimulation electrodes. In an example, electrodes or test parameters can be presented graphically or in a table. A user interface can be configured to receive user-input designating electrode combinations or vectors for test or for use in programming an implantable or ambulatory medical device. The interface can be used to indicate suggested electrode combinations or vectors in response to a first selection of an electrode. Tests can be performed on electrode combinations and vectors, and the results of the tests can be presented to a user using the interactive representation. In an example, test results can be analyzed by a processor and optionally used to program an implantable or ambulatory medical device.

Abstract: Methods for treating anatomic tissue defects such as a patent foramen ovale generally involve positioning a distal end of a catheter device at the site of the defect, exposing a housing and energy transmission member from the distal end of the catheter, engaging the housing with tissues at the site of the defect, applying suction or other approximating tool to the tissue via the housing to bring the tissue together, and applying energy to the tissue with the energy transmission member or to deliver a clip or fixation device to substantially close the defect. Apparatus generally include a catheter body, a housing extending from a distal end of the catheter body for engaging tissue at the site of the defect, and further adapted to house a fusing or fixation device such as an energy transmission member adjacent a distal end of the housing, or a clip or fixation delivery element.

Abstract: New and/or alternative designs for implantable leads that have fixation structures to keep leads at a desired location after implant. Fixation structure may take several forms that create distally located fixation for use primarily in subcutaneous implantation. Some examples include new and/or alternative methods of implanting such leads. Some examples also include fixation structures, such as a suture sleeve, that can be attached to a lead for fixation thereof. Some further examples show methods of implanting a subcutaneous lead, and others include methods of extracting implanted subcutaneous leads.

Abstract: A transvenously implantable medical device (TIMD) includes an electrical lead and a control module. The electrical lead includes one or more electrodes and is adapted for transvenous implantation. The electrical lead is also pre-biased to expand from a collapsed state to an expanded state to mechanically engage an internal wall of a blood vessel. The control module is secured to and in electrical communication with the electrical lead. The control module includes a signal management component and a power component disposed in a housing adapted for implantation into the blood vessel. The control module is adapted for at least one of stimulating and sensing a physiologic response using the one or more electrodes of the electrical lead.

Abstract: An implantable medical lead for coupling to an implantable pulse generator may be configured for improved safety. The lead may include: a first electrode; a second electrode in electrical communication with the first electrode; and an active circuit element in electrical communication with the first electrode and the second electrode. The active circuit element may be configured to change an impedance of the lead. The active circuit element may be configured to change the impedance of the lead in response to a pacing signal or a signal having opposite polarity to a pacing signal. A method of using an implantable medical lead for improved safety may include changing an impedance of an implantable medical lead from a relatively high impedance to a relatively low impedance and/or changing an impedance of an implantable medical lead from a relatively low impedance to a relatively high impedance.

Abstract: A subcutaneous implantable cardioverter-defibrillator is disclosed which has an electrically active canister which houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms. At least one subcutaneous electrode that serves as the opposite electrode from the canister is attached to the canister via a lead system. Cardioversion-defibrillation energy is delivered when the operational circuitry senses a potentially fatal heart rhythm. There are no transvenous, intracardic, or epicardial electrodes. A method of subcutaneously implanting the cardioverter-defibrillator is also disclosed as well as a kit for conducting the method.

Abstract: Electrode plate comprising a stiff or flexible electrically non-conductive plate element having a front face and a rear face and a pattern of needle-like (NL) electrodes for electrical stimulation of cutaneous thin A?/C fibers and conductive plate (CP) electrodes for electrical stimulation cutaneous large A? fibers disposed on the front face.

Abstract: An electrode device for cardiological or neurological electrodiagnosis and/or electrotherapy comprises an elongated electrode body (12), at least one electrode (14, 16) in the vicinity of the distal end (24) of the electrode body (12), and an electrode conductor (44) for the electrical connection of the electrode (14, 16). The electrode conductor (44) has a fibrous structure (52) with anisotropic conductivity so that the specific conductivity of the electrode conductor (44) is significantly higher in its longitudinal direction than in its transverse direction.

Abstract: A medical device lead is presented. The lead includes one or more jacketed conductive elements. The jacket comprises one or more covers. A first cover of polyether ketone (PEEK) is in direct contact with the at least one conductive element. At least one conductive element and a PEEK cover are coiled. The coiled conductive element can substantially retain its original coiled shape.

Abstract: An active fixation lead may have a lead body formed at least in part from an inner member and an outer sheath. The inner member may include a pace/sense lumen and one or more cable lumens. The inner member may include one or more longitudinally extending crumple zones that are configured to reduce stress within the pace/sense lumen that could otherwise be caused by compressive forces applied to the lead.

Abstract: A pacing system includes a controller operable to provide control signals indicating desired pacing signals, a pulse generator connected to the controller and operable to receive the control signals and to generate the desired pacing signals based on the control signals, at least one lead electrically connected to the pulse generator and extending into a user's heart and operable to provide the pacing signals to the heart, at least one electrode positioned in the user's heart and electrically connected to the at least one lead, the at least one electrode in contact with the user's heart and operable to stimulate the heart based on the pacing signals; and a transceiver, in communication with the pulse generator and operable to selectively transmit the pacing signals to the electrode wirelessly. The transceiver is controlled by the controller to transmit the pacing signals when pacing signals are not received by the electrode from the at least one lead.

Abstract: A method for treating patients after a myocardial infarction which includes pacing therapy is disclosed. A cardiac rhythm management device is configured to deliver pre-excitation pacing to one or more sites in proximity to an infarcted region of the ventricular myocardium. Such pacing acts to minimize the remodeling process to which the heart is especially vulnerable immediately after a myocardial infarction.

Abstract: A lead assembly includes a flexible lead body extending from a proximal end to a distal end, and the lead body includes two or more conductors disposed therein. The second conductor is disposed within the first conductor, and the first conductor has a coating of insulation disposed on a portion thereof. In another option, a sleeve of insulative material is disposed between the first conductor and the second conductor.

Abstract: A wire form includes a conductor having a distal end and a proximal end. The conductor is coiled and has a predetermined spacing between adjacent coils. The predetermined spacing provides a parasitic capacitance and an inductance. The parasitic capacitance and inductance have a resonance frequency tuned to about an excitation signal's frequency of a magnetic-resonance imaging scanner.

Abstract: A medical device includes a sensor for sensing for an MRI gradient magnetic field and a microprocessor for responding to the detected gradient magnetic field by switching from a first electrical signal processing mode to a second electrical signal processing mode, such that electrical signals induced by the gradient magnetic field and an associated RF burst are not counted as cardiac events.

Abstract: The invention relates to an arrangement for implanting in a human or animal body, comprising a carrier device which provides a receiving means and which is made from a synthetic mesh or fabric material, and an electronic element which is fixed to the carrier device in the region of the receiving means. Also provided is a method for implanting the arrangement in a human or animal body.

Abstract: A medical lead is configured to be implanted into a patient's body and comprises a lead body, and an electrode coupled to the lead body. The electrode comprises a first section configured to contact the patient's body, and a second section electrically coupled to the first section and configured to be capacitively coupled to the patient's body.

Abstract: A lead assembly and a method of making a lead are provided. The lead comprises a terminal, proximal end having a plurality of terminal contacts and material separating the terminal contacts. In one embodiment of the lead, the terminal contacts are separated by a preformed spacer, that may be made from various hard materials such as polyurethane, PEEK and polysulfone. Epoxy may be used to fill spaces at the proximal lead end, including between the spacer and terminal contacts. In one embodiment of the lead, the terminal contacts are separated by epoxy only. The lead may include a plurality of conductor lumens that contain conductors. The lead may also include a stylet lumen for accepting a stylet.

Abstract: A delivery system for implanting a biostimulation device comprising a stylet extending along an axis from knob end to a threaded end configured to engage an internally threaded nut of the biostimulation device and a catheter tube configured to axially contain the stylet. The catheter tube comprises a feature that engages a corresponding feature on the biostimulation device whereby the stylet can be rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end.

Abstract: An electrode assembly includes an interconnect for at least a first connector electrode and a second connector electrode, where the interconnect provides the mechanical and/or electrical connection between the electrodes. In one example, the assembly is an elongate member having material removed therefrom along an intermediate portion.

Abstract: A device for intracavity stimulation of the left atrium and/or ventricle of the heart from the prepectoral region through a less invasive and lower-risk approach is provided that allows the implantation of an intracavity catheter in the left cardiac chambers through a femoral approach atrial transseptal puncture, and the removal of the catheter proximal end by the retrograde venous route.

Abstract: Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver treatment in the pericardial space are disclosed. A steerable instrument is advanced transvenously into the right atrium of the heart, and a distal segment is deflected into the right atrial appendage. A fixation catheter is advanced employing the steerable instrument to affix a distal fixation mechanism to the atrial wall. A distal segment of an elongated medical device, e.g., a therapeutic catheter or an electrical medical lead, is advanced through the fixation catheter lumen, through the atrial wall, and into the pericardial space. The steerable guide catheter is removed, and the elongated medical device is coupled to an implantable medical device subcutaneously implanted in the thoracic region. The fixation catheter may be left in place.