Abstract: A system and method are provided for securing an ingestible electronic device to a pharmaceutical product without damaging the ingestible electronic device. The product includes the ingestible electronic device being placed on the product in accordance with one aspect of the present invention. In accordance with another aspect of the present invention, the ingestible electronic device is placed inside the product. Various embodiments are disclosed in accordance with the present invention for protecting and/or coating of the electronic marker as well as securing the ingestible electronic device onto the product.

Abstract: Implantable medical leads and methods of forming such leads are disclosed. An implantable medical lead includes a lead body, a swage base coupled to the lead body, and a polymeric member interposed at least in part between the swage base and at least one rigid component of the lead such as an electrode or annular ring. The swage base includes an annular-shaped body including a flange having a number of protrusions that extend radially outward from the flange. During a swaging process, the protrusions on the flange are compressed against the polymeric member, forming a number of channels in the member that mechanically bond the member to the swage base.

Abstract: Impedance devices and methods of using the same to obtain luminal organ measurements. In at least one embodiment of an impedance device of the present disclosure, the impedance device comprises an elongated body having a distal body end, and a first electrode located along the elongated body at or near the distal body end, the first electrode configured to obtain one or more conductance values within a mammalian luminal organ within an electric field, wherein a measured parameter of the mammalian luminal organ can be calculated based in part upon the one or more conductance values obtained by the first electrode.

Abstract: The invention is a method of hermetically bonding a ceramic part to a metal part by welding and brazing a component assembly comprised of metal parts, a ceramic part, and a metal ferrule having alignment lips. The ceramic part is preferably a hollow tube of partially-stabilized zirconia that is brazed to an alignment ferrule that is preferably titanium or a titanium alloy, such as Ti-6Al-4V. On one end the component assembly is brazed to an end cap for closure. On the other end the alignment ferrule is preferably brazed to a ring that is preferably comprised of a noble metal, such as platinum, iridium, or alloys of platinum and iridium. The ring is laser welded to an eyelet that is preferably comprised of a noble metal.

Abstract: An electrode arrangement for sensing electrical activity in target tissue is described. A support electrode has an elongate electrode body with a base end and a penetrating end for insertion into the target tissue. A fixation electrode has an elongate electrode body with a base end and a penetrating end at an angle to the electrode body. The electrodes are joined together with their electrode bodies in parallel so that the penetrating end of the fixation electrode penetrates a fixed distance into the target tissue so that at least one of the electrodes senses electrical activity in the target tissue.

Abstract: A catheter has a distal assembly with at least one loop, if not two, with ring electrodes. The distal assembly has an elongated support member covered by an extruded form having two lumens, one sized for nonslip tight fit with the support member. A single continuous puller wire for bidirectional deflection is pre-bent into two long portions and a U-shape bend therebetween. The U-shape bend is anchored at a distal end of a deflectable section which is reinforced by at least one washer having at least two holes, each hole axially aligned with a respective lumen in the deflectable section. Each hole is centered with a lumen so that each puller wire portion therethrough is straight and subjected to tensile force only. A proximal end of the support member is flattened and serrated to provide a better bonding to the distal end of the deflectable section.

Abstract: A catheter includes a tip electrode with a shell and a support member to provide a plenum chamber. The plug is formed with a U-shaped passage for a safety line to wrap around and secure the support member (with the shell affixed thereto) to the catheter. Additional passages are formed in the plug to accommodate components such as irrigation tubing, lead wire and thermocouple wire pair. A method of manufacture provides distal installation and/or anchoring of the safety line, lead wire and thermocouple wire pair in the support member prior to sealing the support member and mounting the shell.

Abstract: The present disclosure relates to acquiring image data of a subject and selecting image data to be displayed. The image data can include a plurality of frames that relate to a specific location of a tracking device positioned within the subject. The determined location of the tracking device can be used to determine which frame of the image data to display at a selected time.

Abstract: The present invention is a method and apparatus, in several embodiments, for providing protection in workplaces in which workers can be exposed to diseases and other contaminations from skin abrasions or punctures by contaminated objects. In its primary application it provides such protection at skin surfaces of healthcare patients into which needle electrodes have been inserted and, under certain conditions, can emerge. This bio-hazard occurs most often during patient-positioning when patients are unconscious due to anesthesia or other reasons. Protection is supplied in the first embodiment by a puncture-resistant head-covering; in the second by a pad that covers and secures needle electrodes, and; in a third as a tissue-penetrating, less hazardous stick-on electrode. The latter two embodiments have pressure-sensitive-adhesive coatings for adhesion to a patient's skin.

Abstract: A medical microelectrode has a front end, a rear end and a density at 20° C. of from 0.80 to 1.15. The electrode comprises any of: electrically conductive tubiform lead comprising a metal and/or an electrically conductive polymer, the lead having an outer surface and a sealed lumen; electrically conductive wire lead comprising a metal and/or an electrically conductive polymer, the lead having a surface and a buoyant element of a density of less than 1.0 attached to the surface.

Abstract: An apparatus for monitoring EMG signals of a patient's laryngeal muscles includes an endotracheal tube having an exterior surface and a first location configured to be positioned at the patient's vocal folds. A first electrode is formed on the exterior surface of the endotracheal tube substantially below the first location to receive EMG signals primarily from below the vocal folds. A second electrode is formed on the exterior surface of the endotracheal tube substantially above the first location to receive EMG signals primarily from above the vocal folds. The first and second electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient.

Abstract: A cable assembly comprising a signal conductor, a needle electrode electrically connected to the signal conductor and a safety cover having a central passage therein. The signal conductor extends through the central passage. The safety cover is moveable along the signal conductor for allowing the needle electrode to become positioned within the central passage.

Abstract: A lead including one or more electrodes having circuitry associated therewith. Each such electrode includes a circuit extending along and conforming to at least a portion of an inner surface of the electrode. The circuit includes an isolation substrate contacting at least a portion of the inner surface of the cylindrical electrode portion, a first contact electrically isolated from the electrode portion by the isolation substrate and an integrated circuit electrically coupled to the first contact and the electrode.

Abstract: Concepts presented herein include an apparatus for monitoring EMG signals of a patient's laryngeal muscles. The apparatus includes an endobronchial tube having an exterior surface and two lumens for providing ventilation. Conductive ink electrodes are formed on the exterior surface of the endobronchial tube. The conductive ink electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient. At least one conductor is coupled to the conductive ink electrodes and is configured to carry the EMG signals received by the conductive ink electrodes to a processing apparatus.

Abstract: A lead assembly includes a ring component having mechanical coupling features, and at least one polymer component mechanically coupled with the mechanical coupling features of the ring component. Elongate tubing is disposed over the polymer component and is secured with the polymer component.

Abstract: In an example, configuring an implantable medical device by determining port usage can include, receiving a port data object, determining a lead configuration, configuring access to a programmable parameter, and displaying a visual indication of the lead configuration. The port data object can be received from the implantable medical device and can include data associated with a port of the implantable medical device capable of connecting to a lead. The determining a lead configuration can be based on the port data object. The configuring access to a programmable parameter can be based on the lead configuration of the implantable medical device.

Abstract: A flexible, steerable intravascular catheter includes an elongate flexible shaft having a heterogeneous or multi-zone stiffness profile or structure. A first or distal portion of the catheter shaft may have a substantially constant or distinct stiffness or flexibility, a second, intermediate or transition section is proximal relative to, and less flexible than, the first section, and a third section is proximal relative to, and also less more flexible than, the first section. The third section also includes a substantially constant or distinct stiffness or flexibility. The flexibility or stiffness of the second section varies along its length, e.g., in a substantially linear, step-like or ramp-like manner to provide a smooth or gradual transition between the stiffness of the first or distal section and the flexibility or stiffness of the third or proximal section.

Abstract: The invention relates to an electrode arrangement and a measuring device for measuring the action flow and/or the action potential of an electrically active tissue. The aim of the invention is to provide a simple and economically producible electrode for measuring action flows and/or action potentials in electrically active tissues (preferably the stapedius muscle tissue), ensuring that the electrode is fixed securely, but reversibly, in the muscle tissue and that the muscle tissue is disturbed as little as possible. The electrode arrangement according to the invention comprises a first electrode (2) and a fixing element (3), the first electrode (2) being connected to a first, long electrical line (4) and consisting of a long base body (6) comprising a first end (7) and a second end (8). The first electrical line (4) is connected to the base body (6) in the region of the second end (8) thereof, and means are provided for reversibly fixing the fixing element (3) to the first electrode (2).

Abstract: The present invention provides for safe and reliable electronic circuitry that can be employed in ingestible compositions. The ingestible circuitry of the invention includes a solid support; a conductive element; and an electronic component. Each of the support, conductive element and electronic component are fabricated from an ingestible material. The ingestible circuitry finds use in a variety of different applications, including as components of ingestible identifiers, such as may be found in ingestible event markers, e.g., pharma-informatics enabled pharmaceutical compositions.

Abstract: An electrode arrangement is described for sensing electrical activity in target tissue. An inner electrode has an elongate electrode body formed as a cylindrical section with an inner penetrating end for insertion into the stapedius muscle target tissue. An outer electrode fits over the inner electrode and an outer penetrating end for insertion into the target tissue. The two electrodes are joined together with their electrode bodies in parallel so that the penetrating ends of the electrodes penetrate in the same direction into the target tissue to sense electrical activity in the target tissue.

Abstract: Leads for use with implantable medical devices are provided. One microlead is intended to be implanted in the venous, arterial, or lymphatic networks. Its diameter may be at most equal to 1.5 French (0.5 mm), and it may include a plurality of micro-cables each including: an electrically conductive core cable for connection to one pole of a multipolar generator of an active implantable medical device, and a polymer insulation layer surrounding the core cable. At least one exposed area may be formed in the insulation layer to form a detection/stimulation electrode.

Abstract: An atraumatic detection/stimulation lead is disclosed. The lead includes at least one microcable having a core cable comprising a plurality of elementary metal strands. One of the microcables has provided at its distal end an atraumatic protection device. The atraumatic protection device includes a protective coating on the distal ends of the elementary strands of the microcable, and the protective coating is covered by a protective cap of deformable material. The protective cap may be a conical distal end adapted to deform and axially flatten out. The microcable may have an overall diameter less than or equal to 1.5 French (0.50 mm).

Abstract: A medical lead includes a lead body having a proximal end for electrical connection to an implantable electric signal generator and a distal end portion having a plurality of electrodes extending in a helical manner longitudinally along the distal end portion. Adjacent helical electrodes may be offset, for example, 90 degrees or 180 degrees. The helical electrodes may extend less than, greater than, or 360 degrees. The electrode arrangement provides increased surface area, improving the capability of positioning the lead against the nerve as desired.

Abstract: Systems and methods for deploying a sensor assembly onto a cardiac lead are disclosed. The sensor assembly can include a resilient cuff having one or more sensor modules for sensing physiological parameters within the body. The resilient cuff may have a substantially cylindrical shape having an inner diameter that is smaller than an outer diameter of the lead body onto which the cuff is deployed such that the cuff is retained on the lead body by frictional forces. The sensor assembly may be deployed in conjunction with a new lead to be implanted within a chamber of the patient's heart or a body vessel, or may be deployed onto an existing, implanted lead implanted within the patient's body.

Abstract: A medical probe is provided that has a single longitudinally uniform interconnect that provides a connection between a distal end and a proximal end of the probe. The interconnect is obtained by forming a thin uniform film as a spiral on a wafer and subsequently applying this spiral as a helix on a base element of a medical probe. The thin film spiral is manufactured with multiple connecting wires to enable connection between an electronics module and a multiplicity of electrodes (an electrode array) at the distal end of the medical probe.

Abstract: An instrument that utilizes body contact electrodes evaluates the quality of the connections made between the electrodes and the body. An electrode contact quality evaluation circuit performs the quality evaluation, such as by determining contact impedances for the electrodes. The corresponding contact quality of each electrode is conveyed to the user.

Abstract: In one embodiment, a system for wrapping biomedical conductor wires about core material, comprises: a payout assembly and a take-up assembly for controllably paying out the core material and taking up the core material with the wrapped conductor wires; a turntable; a plurality of carriers, disposed on the turntable, for letting out the conductor wires; and a die for applying force to the conductor wires as the wires are wrapped about the core material, the die adapted to rotate according to group rotation of the plurality of carriers by the turntable during operation of the system, wherein the die comprises one or more features asymmetrically arranged about a circumference of the die, the one or more features adapted to direct the conductor wires from the plurality of carriers onto the core material in an axially repeating pattern of groups of closely spaced wires with each group separated by a distance larger than the spacing between adjacent wires within each group.

Abstract: A medical instrument for delivering electrotherapy to tissue that includes an outer support member having a ground plate at a distal end of the outer support member, and a protrusive element having a tip that extends beyond the ground plate. A portion of the protrusive element proximate the ground plate can act as an electrical insulator and a portion of the protrusive element proximate the distal end of the protrusive element can include a first electrode. The protrusive element can be designed to penetrate into tissue below a tissue surface while a tissue contacting surface of the ground plate rests against the tissue surface. Also disclosed are systems incorporating the medical instrument and methods of electrotherapy to subsurface tissue using the medical instrument.

Abstract: MR conditional needle and surface electrode assemblies. The surface electrode utilizes a disc or cone-shaped structure with a bore with a concave bottom surface for receiving a conductive gel and an insulated wire with a connector for an EEG. The needle electrode assembly utilizes a cylindrical-shaped structure and is constructed of an MR conditional material having a needle and an insulated lead wire structure with a connector for an EEG.

Abstract: Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.

Abstract: The invention provides methods for diagnosing and treating asthma in subjects in need thereof but can be applied to other conditions where abnormal electrophysiology underlies dysfunctional organ contractility.

Abstract: This invention relates generally to electro-anatomical mapping method and an apparatus using a catheter and more particularly to a mapping catheter having an embedded MOSFET sensor array for detecting local electrophysiological parameters such as biopotential signals within an excitable cellular matrix geometry, for determining physiological as well as electrical characteristics of conduction path and its underlying substrate within the endocardial and epicardial spaces, the arterial structure and in ganglionic plexus. The apparatus with its MOSFET sensor is geometrically configured as a decapolar linear array and optionally with an 8×8 sensor matrix placed on a balloon-like structure.

Abstract: An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

Abstract: An implantable medical device (IMD) may include a battery dedicated to providing cardiac stimulation therapy and a separate power source that provides power for electrical stimulation therapy. Such a configuration preserves the battery dedicated for providing cardiac stimulation therapy even if the second power source is depleted. As an example, the IMD may comprise a cardiac stimulation module configured to deliver at least one stimulation therapy selected from a group consisting of pacing, cardioversion and defibrillation. The IMD further comprises a electrical stimulation module configured to deliver electrical stimulation therapy, a first power source including a battery, wherein the first power source is configured to supply power to the cardiac stimulation module and not to the electrical stimulation module, and a second power source. The second power source is configured to supply power to at least the electrical stimulation module.

Abstract: A method of detecting cardiac signals in a medical device that includes decomposing a cardiac signal using a wavelet function at a plurality of scales to form a corresponding wavelet transform, determining approximation coefficients in response to the plurality of scales, reconstructing a first wavelet representation of the wavelet transform using predetermined approximation coefficients of the determined approximation coefficients, and evaluating the detected cardiac signals in response to the reconstructing.

Abstract: Devices, systems, and methods for the localization of body lumen junctions and other intraluminal structure are disclosed. Various embodiments permit clinicians to identify and locate lesions and/or anatomical structures within a lumen and accurately place leads and/or devices within a lumen, through determining the intralumen conductance and/or cross-sectional area at a plurality of locations within the body lumen.

Abstract: Provided herein are implantable biomedical devices, methods of administering implantable biomedical devices, methods of making implantable biomedical devices, and methods of using implantable biomedical devices to actuate a target tissue or sense a parameter associated with the target tissue in a biological environment. Each implantable biomedical device comprises a bioresorbable substrate, an electronic device having a plurality of inorganic semiconductor components supported by the bioresorbable substrate, and a barrier layer encapsulating at least a portion of the inorganic semiconductor components. Upon contact with a biological environment the bioresorbable substrate is at least partially resorbed, thereby establishing conformal contact between the implantable biomedical device and the target tissue in the biological environment.

Abstract: The current invention discloses a ribbon strand of four (4) or more color-coded needle electrodes customized for a particular surgical procedure. Each needle electrode includes a needle, a wire with an electrical lead, and an electrical connector. The array of needle electrodes is abuttingly coupled in a linear formation to form a ridged planar surface. The needle and wire of each needle electrode have a predetermined set of dimensions (e.g., length) based on the surgical procedure. The wire of each needle electrode can also be colored to indicate position of application of that needle electrode.

Abstract: A method of forming an implantable medical device includes providing an implantable microstimulator. The microstimulator includes a body with a first end and an opposing second end. The microstimulator further includes internal circuitry that is disposed in the body and that provides stimulation energy. The microstimulator additionally includes a first microstimulator electrode that is electrically coupled to the internal circuitry and that is disposed along the first end portion of the body. The method further includes providing a first lead assembly that includes an insulated conductor with at least one first remote electrode disposed at a distal end of the insulated conductor, and a first connector disposed at a proximal end of the insulated conductor. The first connector is disposed over the first microstimulator electrode to completely cover the first microstimulator electrode. The first connector also electrically couples the insulated conductor to the first microstimulator electrode.

Abstract: Systems and methods for noncontact ablation of tissues or materials in/on the body using a luminal catheter and a catheter inserted into the lumen. In one embodiment, the luminal catheter is an ablation catheter and the other catheter is a recording/measurement/positioning catheter. The luminal catheter incorporates a noncontact ablation element such as an ultrasonic transducer. The luminal catheter can be inserted through the skin and into the body (e.g., into the heart) and the recording/measurement/positioning catheter can be inserted into the lumen so that the ablation and recording/measurement/positioning catheters are simultaneously positioned to record/measure the electrical activity of the target tissue and ablate the target tissue without causing the trauma that results from the introduction of additional catheters. Either of the ablation and recording/measurement/positioning catheters can be steerable, and either may incorporate recording/measurement electrodes.

Abstract: A single sensing probe comprising multiple, spatially separate, sensing sites is utilized to sense neural activity. The sensing probe includes multiple conductors each with multiple sensing sites in a fixed geometric arrangement. The sensing probe is configured to comprise multiple combined sensing sites in polytrode configuration. By appropriately combining the wire groupings at each combined sensing site, activity sensed from a single wire with multiple sensing sites, can be coupled with other wires to unmix signals from the spatially separate sites and leverage the power of combinatorics to maximize total recording bandwidth and single neuron/unit yield per wire and per probe.

Abstract: Embodiments of the invention include analyte-responsive compositions and electrochemical analyte sensors having a sensing layer that includes an analyte-responsive enzyme and a cationic polymer. Also provided are systems and methods of making the sensors and using the electrochemical analyte sensors in analyte monitoring.

Abstract: A system and method for electrically shielding a physiological pathway from electrical noise is disclosed. The method includes the operation of implanting at least one signal microelectrode into a patient such that the signal microelectrode is proximate to the physiological pathway. An additional operation includes substantially enclosing the microelectrode and a section of the physiological pathway with an electrical shielding wrap. The electrical shielding wrap includes a plurality of holes that enable fluid communication of physiological fluids between an inside and outside of the wrap.

Abstract: An MRI-compatible catheter reduces localized heating due to MR scanner-induced currents and includes a shaft having opposite distal and proximal end portions. One or more RF tracking coils are positioned adjacent the distal end portion and each includes a conductive lead that electrically connects the RF tracking coil to an MRI scanner. Each lead includes a series of back and forth segments along its length. The catheter includes one or more sensing electrodes at the shaft distal end portion, each electrically connected to a resistor having high impedance. A sheath surrounds a portion of the elongated shaft and includes at least one RF shield coaxially disposed therewithin. Each RF shield includes elongated inner and outer conductors and an elongated dielectric layer of MRI compatible material sandwiched between the inner and outer conductors. The inner and outer conductors are electrically connected at one end and electrically isolated at an opposite end.

Abstract: An insulative body of a medical electrical lead electrode assembly includes a pre-formed channel having a section extending at an angle to a longitudinal axis of the body. An electrode portion of a conductive component has an electrode contact surface facing outward from a first side of the body and a coupling portion embedded in the body. A conductor, which is coupled to the coupling portion of the component, is disposed in the channel.

Abstract: A self-adhering sensor for non-invasively attaching to a portion of a skin is provided. The sensor comprises a biocompatible substrate, and an array of solid nanoelectrodes coupled to the biocompatible substrate and configured to self-adhere to the skin. Also provided is a sensor for attaching to a portion of a skin, where the sensor comprises an array of solid electrodes configured to self-adhere to the skin, where each of the solid structures comprises a stem and one or more projections extending out from the stem, where both the stem and the projections are solid. The stem comprises a mechanical stopper to control the extent of penetration of the solid electrodes into the skin. The sensor further comprises an electrolyte coating disposed on one or more of the solid structures.

Abstract: Electrical impedance monitoring of a tissue or an organ for perfusion or viability has been limited by sensitivity and baseline shifts. An apparatus and method are described which improve sensitivity by making the intervening tissue between pairs of electrodes a determinant component of electrical resonance. Such sensitivity further enhances detection of the pulsatile component of blood flow within a tissue. Baseline shift can be monitored and compensated due to resonance shift. The method is adaptable to sufficiency of perfusion monitoring or viability, imaging by 2-dimensional or 3-dimensional electrical impedance tomography, monitoring of tissue ablation by thermal or chemical methods, and thermoplasty of tissues to alter their form and functionality.

Abstract: An implantable medical tube arrangement including a tube wall which is resistant to bending loads, tensile loads and radial compressive loads without being damaged and is formed from at least one profiled part which is wound in a coil-shaped manner with the windings abutting against each other, wherein the profiled part's side edge running in the direction of rotation of the coil is connected to the side edge of the adjacent section of the profiled part by means of an engaging mechanism. At least one electrically conductive wire- or rope-like insertion strand is connected to the profiled par. An electrically conductive configuration of the profiled part itself is also possible.

Abstract: The present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Abstract: Methods and devices to detect analyte in body fluid are provided. Embodiments include enhanced analyte monitoring devices and systems.