Abstract: A leadless intra-cardiac medical device (LIMD) configured to be implanted entirely within a heart of a patient includes a housing configured to be securely attached to an interior wall portion of a chamber of the heart, and a stabilizing intra-cardiac (IC) device extension connected to the housing. The stabilizing IC device extension may include a stabilizer arm, and/or an appendage arm, or an elongated body or a loop member configured to be passively secured within the heart.

Abstract: A leadless intra-cardiac medical device includes a housing that is configured to be implanted entirely within a single local chamber of the heart. A first electrode is provided on the housing at a first position such that when the housing is implanted in the local chamber, the first electrode engages the local wall tissue at a local activation site within the conduction network of the local chamber. An intra-cardiac extension is coupled to the housing and configured to extend from the local chamber into an adjacent chamber of the heart. A stabilization arm of the intra-cardiac extension engages the adjacent chamber. A second electrode on the intra-cardiac extension engages distal wall tissue at a distal activation site within the conduction network of the adjacent chamber.

Abstract: An assembly for introducing a leadless intra-cardiac medical device includes a sheath having an internal passage, wherein the sheath is configured to be maneuvered into the heart of the patient. A housing may be retained within the internal passage, wherein the housing is configured to be pushed out of the sheath, the housing having a first anchoring member configured to anchor the housing to a first implant location within the heart. The assembly may also include an electrode trailing the housing within the internal passage, wherein the electrode is also configured to be pushed out of the sheath. The electrode has a second anchoring member configured to anchor the electrode to a second implant location within the heart. A conductive wire connects the housing to the electrode, wherein movement of the housing out of the sheath causes the electrode to follow the movement to a distal end of the sheath.

Abstract: A leadless intra-cardiac medical device (LIMD) includes an electrode assembly configured to be anchored within a first wall portion of a first chamber of a heart. The electrode assembly includes an electrode main body having a first securing helix, an electrode wire segment extending from the body, and a first segment-terminating contact positioned on the electrode wire segment. The device further includes a housing assembly configured to be anchored within a second wall portion of a second chamber of the heart. The housing assembly includes a body having a second securing helix, a housing wire segment extending from the body, and a second segment-terminating contact positioned on the housing wire segment. The device also includes a connector block that electrically connects the electrode wire segment to the housing wire segment by retaining the first and second segment-terminating contacts.

Abstract: A renal denervation feedback method is described that performs a baseline measurement of renal nerve plexus electrical activity at a renal vessel; denervates at least some tissue proximate the renal vessel after performing the baseline measurement; performs a post-denervation measurement of renal nerve plexus electrical activity at the renal vessel, after the denervating; and assesses denervation of the renal vessel based on a comparison of the baseline measurement and the post-denervation measurement of renal nerve plexus electrical activity at the renal vessel.

Abstract: A method for detecting potential failures by a lead of an implantable medical device is provided. The method includes sensing a first signal over a first channel between a first combination of electrodes on the lead and sensing a second signal from a second channel between a second combination of electrodes on the lead. The method determines whether at least one of the first and second signals is representative of a potential failure in the lead and identifies a failure and the electrode associated with the failure based on which of the first and second sensed signals is representative of the potential failure. Optionally, when the first and second sensed signals are both representative of the potential failure, the method further includes determining whether the first and second sensed signals are correlated with one another. When the first and second sensed signals are correlated, the method declares an electrode common to both of the first and second combinations to be associated with the failure.

Abstract: Methods of processing venous oxygen saturation and hematrocrit information in an implantable sensor are provided. In an embodiment a method for collecting data from an implantable multi-wavelength SvO2 sensor having multiple light sources is provided. The method includes receiving a frame signal that indicates a beginning of the light sources being turned on and receiving a light source signal that indicates a light source is on. The output of a photodetector is sampled to measure the intensity of the transmitted light. The process is repeated for each light source to gather intensity measurements that then can be used to generate venous oxygen saturation and hematocrit measurements.

Abstract: An intravenous implantable optical sensor assesses the relative absorbance of multiple wavelengths of light in order to determine oxygen saturation. The calculation of oxygen saturation is enhanced by use of a function of hematocrit which is derived from the relative absorbance of light of an isobestic wavelength along two different length paths through the blood. The use of the hematocrit-dependent term and multiple wavelengths of light to calculate oxygen saturation provides results that are less susceptible to noise and variation in hematocrit and thus provides a more accurate measure of oxygen saturation over a wider range of conditions than previously possible. The optical sensor may form part of an implantable system which performs the calculation of oxygen saturation and uses the results for a diagnostic or therapeutic purpose.

Abstract: A process for determining whether the location of a stimulation electrode meets a selected heart performance criteria includes providing stimulation to the heart through the electrode and obtaining an impedance measurement during stimulation delivery using an impedance sensing vector formed by electrodes that do not include the stimulation electrode. The impedance measurements are processed, either alone or in combination with an electrogram, also obtained during stimulation, to obtain a measure of hemodynamic performance.

Abstract: A bioelectric battery may be used to power implantable devices. The bioelectric battery may have an anode electrode and a cathode electrode separated by an insulating member comprising a tube having a first end and a second end, wherein said anode is inserted into said first end of said tube and said cathode surrounds said tube such that the tube provides a support for the cathode electrode. The bioelectric battery may also have a membrane surrounding the cathode to reduce tissue encapsulation. Alternatively, an anode electrode, a cathode electrode surrounding the cathode electrode, a permeable membrane surrounding the cathode electrode. An electrolyte is disposed within the permeable membrane and a mesh surrounds the permeable membrane. In an alternative embodiment, a pacemaker housing acts as a cathode electrode for a bioelectric battery and an anode electrode is attached to the housing with an insulative adhesive.

Abstract: Methods for assessing, diagnosing and treating medical conditions using SvO2 and hematocrit measurements alone, or in combination with other measurements related to cardiac activity are provided. These includes methods for distinguishing true anemia from diluted anemia, methods for anemia detection, methods for measuring disease progression based on anemia trending, methods for managing therapy delivery, methods for managing heart failure drug therapies, methods for cardiac output optimization based on SvO2, methods for cardiac resynchronization therapy lead placement, method for detection of heart failure decompensation, and methods to monitor and treat systolic versus diastolic heart failure are provided.

Abstract: A high Q self-resonant inductor and method for manufacturing the same is disclosed herein for use in an implantable medical lead. The method of manufacture includes depositing a first conductive material over an elongated ceramic member and removing portions of the conductive material to leave a continuous helical metallic pattern on an elongated ceramic structure. The helical metallic pattern has a first terminal end located at a proximal end of the elongated ceramic member and a second terminal end located at a distal end of the ceramic member. The method also includes covering the helical metallic pattern with a ceramic material to form a first ceramic layer and forming vias in the ceramic material. At least one electrode is coupled to the helical metallic pattern through the vias in the ceramic material.

Abstract: A method for detecting potential failures by a lead of an implantable medical device is provided. The method includes sensing a first signal over a first channel between a first combination of electrodes on the lead and sensing a second signal from a second channel between a second combination of electrodes on the lead. The method determines whether at least one of the first and second signals is representative of a potential failure in the lead and identifies a failure and the electrode associated with the failure based on which of the first and second sensed signals is representative of the potential failure. Optionally, when the first and second sensed signals are both representative of the potential failure, the method further includes determining whether the first and second sensed signals are correlated with one another. When the first and second sensed signals are correlated, the method declares an electrode common to both of the first and second combinations to be associated with the failure.

Abstract: A stimulation device that includes a housing, a neuro lead configured to be coupled to the housing and to be located proximate to a neurostimulation site of interest, a neuro pulse generator, in the housing, configured to generate multi-polar neuro modulation (NM) pulses for delivery by the lead to the neuromodulation site of interest and the neuro pulse generator generating the NM pulses utilizing a waveform, with the frequency components of the ICMD compatible waveform in a range of 0 to 225 Hz having substantially limited NM energy content to avoid interference with sensing operation of the ICMD.

Abstract: A measurement light detector detects light transmitted by a light source of an implantable system that is scattered back into an implantable housing, and produces a measurement signal indicative of the intensity of the light detected by the measurement light detector. A calibration light detector detects a portion of the transmitted light that has not exited the housing, and produces a calibration signal that is indicative of the intensity of the light detected by the calibration light detector, which is indicative of the intensity of the light transmitted by the light source. Changes in the intensity of the transmitted light are compensated for based on the calibration signal produced by the calibration light detector. This description is not intended to be a complete description of, or limit the scope of, the invention. Other features, aspects, and objects of the invention can be obtained from a review of the specification, the figures, and the claims.

Abstract: A system for pericardial lead implantation is disclosed herein. The system includes an implantation tool and a stimulation lead. The implantation tool includes a tubular body, a first lumen, a second lumen, a stylet or guidewire, a first port, and a second port. The first and second lumens longitudinally extend through tubular body. The first port is in communication with the first lumen, and the second port is in communication with the second lumen. The stylet or guidewire is longitudinally displaceable in the first lumen and across the first port. A tissue adhesive is selectively administrable through the second port via the second lumen. The stimulation lead includes a distal end and an engagement feature. Placing the engagement feature in the first port and causing the stylet or guidewire to displace in a first direction across the first port causes the lead to attach to the implantation tool.

Abstract: A process for determining whether the location of a stimulation electrode meets a selected heart performance criteria includes providing stimulation to the heart through the electrode and obtaining an impedance measurement during stimulation delivery using an impedance sensing vector formed by electrodes that do not include the stimulation electrode. The impedance measurements are processed, either alone or in combination with an electrogram, also obtained during stimulation, to obtain a measure of hemodynamic performance.

Abstract: A system and method for powering an implantable cardiac therapy device (ICTD) via a hybrid battery system. The hybrid battery is comprised of a low voltage and low current bioelectric cell, a high voltage and high current rechargeable cell, and a charging means. Via the charging means, the bioelectric cell maintains the rechargeable cell at or near full power. The rechargeable cell is configured to power some or all operations of the ICTD. Some ICTD operations may be powered directly by the bioelectric cell. The rechargeable cell is further configured to be charged via a continuous charging process, reducing the complexity of the charging circuitry. In an embodiment, at least the bioelectric cell is external to the ICTD, enabling easy replacement of this power source. In an embodiment, a consumable anode of the bioelectric cell is external to the ICTD, enabling replacement of the power source by replacing only the anode.

Abstract: A lead implantation system with an introducer, a lead configured to engage with the introducer such that the introducer can convey the lead to a desired internal target location, and at least one sensor. The sensor is adapted to generate an indicator of desired engagement of the system with the desired target tissue location prior to engagement of the lead with the target tissue. Also a method of implanting an implantable patient lead including advancing a lead implantation assembly towards a desired target location along an introduction axis and monitoring at least one indicator of lead implantation assembly position along the lead introduction axis. At least one indicator can be generated by the lead implantation assembly. Advancing of the lead introduction assembly can be halted when the monitoring indicates contact with the desired target tissue. The patient lead can then be advanced towards the target tissue and fixed to the target tissue.

Abstract: Implantable multi-wavelength oximetry sensors, which can be used to monitor a patient's blood oxygen saturation level, are described. The sensor includes an implantable sensor housing within which are located a plurality of light sources that each transmits light of a different wavelength. Also within the sensor housing are one or more surfaces that are configured to combine the light from the plurality of light sources into a beam of light for transmission through a portion of the housing (e.g., a window) through which light can exit and enter the housing. Additionally, a light detector is located within the sensor housing, to detect light scattered by blood back into the housing. This description is not intended to be a complete description of, or limit the scope of, the invention. Other features, aspects, and objects of the invention can be obtained from a review of the specification, the figures, and the claims.