Abstract: A compact height torque sensing articulation axis assembly is disclosed herein having a torque sensor, an assembly mounting flange, a motor, a motor gearbox, a gearbox output shaft, an encoder, and a cable. The assembly may sense tension on robotic catheter pullwires in an articulating catheter and/or torque on a robotic output axis using the torque sensor. Disclosed embodiments may advantageously be used to achieve small, lightweight robotic catheter systems.

Abstract: The present invention is a catheter actuation handle for deflecting a distal end of a tubular catheter body, the handle including an auto-locking mechanism. The handle comprises upper and lower grip portions, an actuator, and an auto-locking mechanism. The auto-locking mechanism is adapted to hold a deflected distal end of the catheter in place without input from the operator. When the distal end of the catheter is deflected from its zero position, it typically will seek a return to its zero position, and as a result exerts a force on the actuator. The auto-locking mechanism acts by providing a second force that resists this force from the distal end and holds the distal end in place. As a result, the operator does not need to maintain contact with the buttons to maintain the distal end 18 in a set position once placed there by actuating the actuator.

Abstract: A guide wire capable of exhibiting improved penetrability for penetrating a stenosis without degradation of passing performance of the guide wire. A guide wire includes a wire main body formed into a linear shape, a distal end portion of the wire main body is formed into a curved shape by a top portion that forms an extreme distal portion and a surrounding portion that makes the top portion continuous with a peripheral surface of the wire main body, a plurality of recesses are formed in the distal end portion, and the recesses are formed in the top portion and the surrounding portion, respectively.

Abstract: A medical device includes an inflatable balloon defining an interior surface and an exterior surface, and a coating including a therapeutic agent disposed on the exterior surface of the inflatable balloon. The coating has a release transition temperature within a range from about 25° C. to about 50° C. When the temperature of the coating is below the release transition temperature, the coating retains at least a portion of the therapeutic agent on the exterior of the inflatable balloon. When the temperature of the coating is above the release transition temperature, the coating releases at least a portion of the therapeutic agent from the exterior of the inflatable balloon.

Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: A device for regulating blood pressure in a heart chamber is provided. The device includes a shunt positionable within a septum of the heart. The shunt is designed for enabling blood flow between a left heart chamber and a right heart chamber, wherein the flow rate capacity of the device is mostly a function of pressure in the left heart chamber.

Abstract: A balloon catheter including an elongated catheter main body portion and a balloon provided on the distal portion of the catheter main body portion. The balloon is inflatable to expand radially outward into an inflated state and deflatable to contract radially inward into a deflated state. The catheter main body portion includes a hollow outer tube and a hollow inner tube disposed within the outer tube. The balloon includes a contact portion that contacts the outer surface of the inner tube and a vane portion protruding from the contact portion radially outward when the balloon is in the deflated state. The contact portion of the balloon includes a connecting portion that connects the balloon to the catheter main body portion.

Abstract: A drug delivery device that delivers pharmacologically active substances transdermally using microneedles arranged on a belt mounted rotatably about a plurality of rollers, the microneedles having an associated drug reservoir mounted on the belt which is compressed when the needles and belt arc brought into contact with the skin.

Abstract: Methods for fabricating metallic microneedles are disclosed. One method comprises providing a mold pillar; forming an apertured electrically-conductive layer over the mold pillar; and depositing a metal layer over the electrically-conductive layer to provide an apertured microneedle. Another method comprises providing a mold pillar; depositing a first metal layer over the mold pillar to provide a first microneedle; removing the first microneedle from the mold pillar; and depositing a second metal layer over the mold pillar to provide a second microneedle.

Abstract: There is disclosed systems and methods for non-invasive delivery of an agent to biological tissues. Delivery of the agent to the tissues can be by one or more modalities. In some embodiments the systems and methods use agent carrier body including a tissue contacting surface for non-invasively engaging tissues under treatment. The tissue contacting surface can be at least partly defined by a plurality of protrusions that are in fluid communication with one or more reservoirs forming part of the agent carrier body. The protrusions may extend outward from an inside of a void and terminate at said tissue contacting surface.

Abstract: Systems and methods are adapted for treating the carotid artery. The systems include interventional catheters and blood vessel access devices that are adapted for transcervical insertion into the carotid artery. Embodiments of the systems and methods can be used in combination with embolic protection systems including blood flow reversal mechanisms, arterial filters, and arterial occlusion devices.

Abstract: A system for providing vascular access in a patient's body may comprise at least one hemostatic valve (610) and at least one clamp (210) to be used with a vascular graft (110). The vascular graft (110) comprises a tubular body having a proximal end (110A) and a distal end (110B), the proximal end (110A) being configured to be attached to a vessel in a patient's body. The at least one valve (610) is configured to be attached to the distal end (110B) of the graft's tubular body and comprises a housing (616) including a flexible membrane (611) that allows a medical device (810) to be inserted through the membrane (611) into said vascular graft (110). The valve (610) further comprises an introducer sheath (615) configured to be inserted into the distal end (110B) of the graft's tubular body.

Abstract: Methods and devices are described for preventing diastolic flow reversal and/or reducing peripheral vascular resistance in a patient. Also described are methods of cosmetic treatment, and methods of promoting delivery of therapeutic agents or contrast agents to bones and related tissues.

Abstract: A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves.

Abstract: An extractor for removing an implanted lead from a patient, the extractor comprising a proximal portion, a distal portion, a lumen dimensioned to receive the lead therein, a cutter at the distal portion for cutting tissue adjacent the implanted lead, and a first clamping member movable between a clamping position to clamp the lead and an unclamping position to unclamp the lead. The extractor and lead are relatively movable to remove the lead.

Abstract: A catheter inner assembly includes a receptacle with an interior contour configured to mate with a head and neck contour of a holding member of an implantable medical device; and a laterally facing opening of the receptacle has a profile matching a longitudinal profile of the head and neck. Thus, the opening allows only a properly oriented passage of the holding member therethrough, the passage being without deformation of holding member or opening. The inner assembly further includes a lock and release member useful for securing the device to the catheter, when the holding member has been passed through the receptacle's opening to mate with the receptacle's interior contour. The lock and release member may include an arcuate sidewall moveable between a first location, at which the sidewall overlays the laterally facing opening, and a second location, at which the sidewall is located proximal to the opening.

Abstract: A catheter for assisting recovery from dysphagia comprising: a feeding tube; a sleeve for receiving the feeding tube and being movable longitudinally relative to the feeding tube, and a retaining formation attached to the sleeve for fixing the position of the sleeve relative to the feeding tube, wherein the retaining formation comprises a first part and a second part connected by a living hinge, the second part being movable relative to the first part between an open position whereby the sleeve can be moved longitudinally relative to the feeding tube and a closed position, whereby the feeding tube is clamped between the first part and the second part to positionally fix the sleeve relative to the feeding tube.

Abstract: An insertion tool having an insertion guide tube that maintains a perimodiolar or other pre-curved electrode assembly in a substantially straight configuration while preventing the electrode assembly from twisting in response to stresses induced by the bias force which urges the assembly to return to its pre-curved configuration. This generally ensures that when the electrode assembly is deployed from the distal end of the insertion guide tube, the electrode assembly and insertion guide tube have a known relative orientation.

Abstract: Devices, systems and methods are provided for accessing and treating anatomies associated with a variety of conditions while minimizing possible complications and side effects. This is achieved by directly neuromodulating a target anatomy associated with the condition while minimizing or excluding undesired neuromodulation of other anatomies. Typically, this involves stimulating portions of neural tissue of the central nervous system, wherein the central nervous system includes the spinal cord and the pairs of nerves along the spinal cord which are known as spinal nerves. In particular, some embodiments of the present invention are used to selectively stimulate portions of the spinal nerves, particularly one or more dorsal root ganglions (DRGs), to treat chronic pain while causing minimal deleterious side effects such as undesired motor responses.

Abstract: An implantable medical electrical lead includes an electrode assembly in which an electrical junction between a first conductor and an inner surface of a first electrode of the assembly is wedged within a first channel of at least one core member of the assembly, around which the first electrode extends. The at least one core member is formed from an insulating material, and the first channel may be one of a plurality of longitudinally extending channels arrayed around a circumference of a central lumen of the assembly, which is defined by the at least one core member. The first conductor extends along a length of the assembly, for example, defined between the first electrode and a second electrode thereof, in a helical path that travels around the central lumen.

Abstract: Disclosed herein is an implantable lead configured to administer electrotherapy to a patient heart from an implantable pulse generator. The lead may include a lead body and an attachment structure. The lead body includes a bifurcated distal region including first and second lead body branches each terminating in a distal end. At least one of the first lead body branch or second lead body branch includes an electrode. The attachment structure couples together the distal ends of the first and second lead body branches. The attachment structure is configured to release such that the distal ends of the first and second lead body branches can decouple from each other.

Abstract: Implantable medical devices automatically switch from a normal mode of operation to an exposure mode of operation and back to the normal mode of operation. The implantable medical devices may utilize hysteresis timers in order to determine if entry and/or exit criteria for the exposure mode are met. The implantable medical devices may utilize additional considerations for entry to the exposure mode such as a confirmation counter or a moving buffer of sensor values. The implantable medical devices may utilize additional considerations for exiting the exposure mode of operation and returning to the normal mode, such as total time in the exposure mode, patient position, and high voltage source charge time in the case of devices with defibrillation capabilities.

Abstract: A method, including subjecting a subcutaneous medical device containing a magnet to a magnetic field, thereby imparting a torque onto the magnet, and resisting the imparted torque via an external device that has a skin facing component extending in a direction away from a curvature of the body of the recipient at locations proximate a portion directly contacting skin directly above the implanted magnet.

Abstract: An implant for the cardiovascular system is provided, the implant is insertable into an organ and includes a body structure configured to be disposed inside an organ; and an electret coating disposed on the body structure; wherein the electret coating includes a negative charge such that a negative electrostatic field is formed in proximity of the body structure, the charge is such that the negative electrostatic field corresponds to a positive electrostatic field formed by a damaged tissue of the organ.

Abstract: Modulation of target effector organs in vertebrate beings using direct current stimulation for stimulation of spinal cord at regions of autonomic innervation, using direct current for peripheral nerve stimulation, by modulating central autonomic outflow and combinations thereof.

Abstract: A system and method for relieving high blood sugar factor of diabetes includes an energy wave generator with an energy wave's frequency control mode. The energy wave's frequency control mode includes multiple controls for controlling and generating energy waves with corresponding energy densities to effect on diabetic patient's body, so as to reduce and eliminate the high blood sugar factors of the diabetic patient.

Abstract: A lead for placement on a diaphragm includes a sensor assembly, a connector, and a lead body. The sensor assembly includes a housing having a first end surface and a second end surface opposite the first end surface. The first end surface is intended to contact the diaphragm. The sensor assembly includes at least one fixation structure also associated with the first end surface. The fixation structure is configured to preserve the hermetic integrity of the intrathoracic cavity. The fixation structure may extend through the diaphragm and transition to a state that forms a seal between itself and tissue of the diaphragm. Alternatively, the fixation structure may surround the sensor assembly and form a seal between itself and the surface of the diaphragm.

Abstract: A controller delivers electrical stimulation therapy to a diaphragm through the one or more electrodes, and obtains a signal indicative of a pressure within an intrathoracic cavity from a pressure measurement source. The electrical stimulation therapy is defined by stimulation parameters. The controller obtains at least one additional signal indicative of a pressure within an intrathoracic cavity by changing at least one of the stimulation parameters, and delivering an electrical stimulation therapy to the diaphragm in accordance with the changed one of the plurality of stimulation parameters. The controller repeats the process of obtaining additional signals indicative of pressure based on a changing stimulation parameter by scanning through a range of values for the changing stimulation parameter.

Abstract: A controller detects a cyclic cardiac event of the patient based on a signal obtained from one or more electrodes configured for placement on or near a diaphragm, and delivers an electrical stimulation therapy to a diaphragm of the patient through the one or more electrodes. The delivery of electrical stimulation therapy is timed to the detection of the cyclic cardiac event, and the electrical stimulation therapy is defined by stimulation parameters. The controller monitors a pressure associated with the intrathoracic cavity of the patient based on a signal provided by a pressure measurement source configured to provide a signal indicative of a pressure within an intrathoracic cavity, to determine whether an adjustment of one or more of the stimulation parameters is warranted.

Abstract: In some examples, an implantable medical device determines that another medical device delivered an anti-tachyarrhythmia shock, and delivers post-shock pacing in response to the determination. The implantable medical device may be configured to both detect the delivery of the shock in a sensed electrical signal and, if delivery of the shock is not detected, determine that the shock was delivered based on detection of asystole of the heart. The asystole may be detected based on the sensed electrical signal. In some examples, an implantable medical device is configured to revert from a post-shock pacing mode to a baseline pacing mode by iteratively testing a plurality of decreasing values of pacing pulse magnitude until loss of capture is detected. The implantable medical device may update a baseline value of the pacing pulse magnitude for the baseline mode based on the detection of loss of capture.

Abstract: A cochlear implant sound processor including processor apparatus that, in response to being paired with a cochlear implant, converts audio signals from a microphone into stimulation data and transfer the stimulation data to cochlear implant, and in response to a failure to detect the cochlear implant, transfers the audio signals to a contralateral sound processor. Systems and methods are also disclosed.

Abstract: A topical nerve stimulator patch and system are provided comprising a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

Abstract: A method for treating a disorder of a patient. The method comprises transcutaneously delivering electrical energy to a targeted tissue site at a frequency of at least 50 KHz, thereby treating the disorder.

Abstract: An implantable medical device comprising a signal generator configured to generate and deliver anti-tachyarrhythmia pacing (ATP) to a heart of a patient and processing circuitry. The processing circuitry is configured to detect an enable event, responsive to detecting the enable event, enable the delivery of ATP by the signal generator, detect a disable event indicating that another implantable medical device cannot be relied upon to deliver an anti-tachyarrhythmia shock, and responsive to detecting the disable event, disable delivery of ATP.

Abstract: Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising: a housing; an application unit for providing mechanical coupling between the housing and the user's body; a stimulation unit for electrically stimulating at least one nerve of the user; a sensing unit for (i) sensing the user's body movement and body orientation to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing the sleep characteristics of the user during the “rest-in-bed” state; and a feedback unit for at least one of (i) providing the user with feedback in response to the analysis of the sleep characteristics of the user, and (ii) modifying the electrical stimulation provided to the user by the stimulation unit in response to the analysis of the sleep characteristics of the user; wherein the sleep characteristics comprise a likelihood measure of the user's sleep quality.

Abstract: An implantable medical device comprises therapy delivery circuitry and processing circuitry. The therapy delivery circuitry is configured to deliver anti-tachycardia pacing (ATP) therapy to a heart of a patient. The ATP therapy includes one or more pulse trains and each of the one or more pulse trains includes a plurality of pacing pulses. The processing circuitry is configured to, for at least one of the plurality of pacing pulses of at least one of the one or more pulse trains, determine at least one latency metric of an evoked response of the heart to the pacing pulse. The processing circuitry is further configured to modify the ATP therapy based on the at least one latency metric.

Abstract: Described is a system for training and assessment. In operation, the system classifies a subject's baseline brain state and behavioral performance. Training goals are assessed to specify tasks the subject is to perform and a desired level of performance. The subject is subjected to neurological stimulation while the subject performs specified tasks. Behavioral data is assessed to determine if the subject has achieved the training goals. If the subject has achieved the training goals, the system stops. Alternatively, if the individual has not achieved the training goals, then neurological data is reviewed to identify activation states and values of the neurological stimulation that resulted in increased performance values from the baseline behavioral performance. The activation states and values of the neurological stimulation are adjusted to match those that resulted in increased performance values. The process is repeated until the subject has achieved the training goals.

Abstract: Described is a system for automatic adjustment of neurostimulation. The system controls stimulation of specific neural regions through a neural device positioned on a human subject, while simultaneously performing recordings from the neural device using a targeted arrangement of stimulating electrodes and distinct types of recording electrodes of the neural device. Stimulation of the specific neural regions is adjusted in real-time based on the recordings from the neural device.

Abstract: Described is a system for the therapeutic modification of human behavior and, more specifically, a system for the transcranial control of procedural memory reconsolidation for the purposes of enhanced skill acquisition. During operation the system records a practice pattern. The practice pattern is a recording of a sensed brain activity from a sensor array when a subject is performing a skill. The practice pattern is converted to brain activity voxels and stored as both an uncompressed practice pattern and a compressed practice pattern.

Abstract: A system to measure intracardiac impedance includes implantable electrodes and a medical device. The electrodes sense electrical signals of a heart of a subject. The medical device includes a cardiac signal sensing circuit coupled to the implantable electrodes, an impedance measurement circuit coupled to the same or different implantable electrodes, and a controller circuit coupled to the cardiac signal sensing circuit and the impedance measurement circuit. The cardiac signal sensing circuit provides a sensed cardiac signal. The impedance measurement circuit senses intracardiac impedance between the electrodes to obtain an intracardiac impedance signal. The controller circuit determines cardiac cycles of the subject using the sensed cardiac signal, and detects tachyarrhythmia using cardiac-cycle to cardiac-cycle changes in a plurality of intracardiac impedance parameters obtained from the intracardiac impedance signal.

Abstract: Described here are devices, systems, and methods for treating meibomian gland disease and/or blepharitis by providing intranasal stimulation. Generally, the devices may deliver electrical stimulation to the nasal mucosa. Intranasal stimulation may unblock obstructed meibomian glands and increase the lipid content of tears, both acutely during stimulation and subsequent to intranasal stimulation. The methods may include an initial round of stimulation to unblock obstructed meibomian glands, and subsequent shorter rounds of stimulation to cause meibum secretion and maintain the open glands.

Abstract: A technology is described for an electronic peripheral nerve stimulation system. The electronic nerve stimulation system can include a stimulation device and an electrode array. The stimulation device can be operable to generate a high-frequency alternating current. The electrode array can be operable to apply the high-frequency alternating current received from the stimulation device to selected subpopulations of peripheral nerve fibers within a peripheral nerve to block transmission of neural signals along the selected subpopulations of peripheral nerve fibers within the peripheral nerve.

Abstract: Embodiments of the present invention provide systems and methods for the treatment of pain through activation of select neural fibers. The neural fibers may comprise one or more afferent neural fibers and/or one or more efferent neural fibers. If afferent fibers are stimulated, alone or in combination with efferent fibers, a therapeutically effective amount of electrical stimulation is applied to activate afferent pathways in a manner approximating natural afferent activity. The afferent fibers may be associated with primary receptors of muscle spindles, golgi tendon organs, secondary receptors of muscle spindles, joint receptors, touch receptors, and other types of mechanoreceptors and/or proprioceptors. If efferent fibers are stimulated, alone or in combination with afferent fibers, a therapeutically effective amount of electrical stimulation is applied to activate intrafusal and/or extrafusal muscle fibers, which results in an indirect activation of afferent fibers associated therewith.

Abstract: The present disclosure may take the form of a method of optimizing CRT wherein candidate pacing settings are administered at a candidate lead implantation site. Such a method may comprise: determining a navigation sensor path at a measurement site for each candidate pacing setting at the candidate lead implantation site; and identifying which navigation sensor path corresponds to a most efficient cardiac tissue displacement.

Abstract: A catheter system configured for delivering a neuromodulation therapy, includes a first therapeutic element positionable in a first target vessel selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, right brachiocephalic vein, azygos vein or azygos arch, and a second therapeutic element in a second target vessel selected from the group of blood vessels consisting of the superior vena cava, left brachiocephalic vein, right brachiocephalic vein, internal jugular vein, azygos vein or azygos arch. The system and associated method deliver therapeutic energy to at least one parasympathetic nerve fiber external to the first target vessel using the first therapeutic element, and deliver therapeutic energy to at least one sympathetic nerve fiber external to the second target vessel using the second therapeutic element.

Abstract: An electrical stimulation system for use with a plurality of electrodes implanted within a tissue region comprises a neurostimulator configured for delivering electrical stimulation energy to the plurality of electrodes in accordance with a set of stimulation parameters, thereby injecting a charge into the tissue region, a control device configured for receiving user input to modify the set of stimulation parameters, and controller/processor circuitry configured for, in response to the user input computing a charge injection metric value as a function of a physical electrode parameter and an electrical source parameter for a first set of the electrodes, wherein the electrode set comprises at least two electrodes, comparing the computed charge injection metric value to a safety threshold value, and performing a corrective action based on the comparison.

Abstract: Systems and methods for stimulation of neurological tissue apply a stimulation waveform that is derived by a developed genetic algorithm (GA), which may be coupled to a computational model of extracellular stimulation of a mammalian myelinated axon. The waveform is optimized for energy efficiency.

Abstract: The present disclosure provides a method of forming a hermetically sealed enclosure that comprises a diamond material. The method comprises providing first and second enclosure components comprising the diamond material and having first and second recesses, respectively, at edge portions. At least one of the first and second enclosure components has a cavity. The enclosure components have respective contact surfaces at the first and second recesses and are shaped such that an outer channel is formed by the co-operation of the first and second recesses when the first and second enclosure components are contacted at the contact surfaces to form the enclosure. The method further comprises bonding a first type of material to at least surface portions of the first and second recesses of the first and second enclosure components, respectively.

Abstract: A stimulation system includes an implantable pulse generator having a sealed chamber and an electronic subassembly disposed in the sealed chamber. Feed through pins are coupled to the electronic subassembly and extend out of the sealed chamber. Feed through interconnects are coupled to the electronic subassembly via the feed through pins. At least one tab is disposed on at least one feed through interconnect. The tab(s) are configured and arranged to flex away from the feed through interconnect and against a side of the feed through pin. A feed through interconnect assembly includes an assembly frame; feed through interconnects extending from the assembly frame; a first contact pad and a second contact pad disposed on at least one of the feed through interconnects; and a tab formed on a first contact pad of at least one of the feed through interconnects.

Abstract: Systems, apparatus, methods and computer-readable storage media facilitating management of operation of an implantable medical device (“IMD”) using a number of communication modes are provided. An IMD is configured to operate in a disabled mode wherein radio frequency (RF) telemetry communication is disabled, or operate in a first advertising mode using the RF telemetry communication. The IMD receives a clinician session request from a clinician device via an induction telemetry protocol while operating in the disabled mode or the first advertising mode, and transitions to operating from the disabled mode or the first advertising mode to operating in a second advertising mode based on receiving the clinician session request. From the second advertising mode, the IMD can establish a clinician telemetry session with the clinician device using the RF telemetry communication and a unique security mechanism facilitated by an identifier for the clinician device included in the clinician session request.