Abstract: Systems, methods, and computer program product embodiments are disclosed for performing electrophysiology (EP) signal processing. An embodiment includes an electrocardiogram (ECG) circuit board configured to process an ECG signal. The embodiment further includes a plurality of intracardiac (IC) circuit boards, each configured to process a corresponding IC signal. The ECG circuit board and the plurality of IC circuit boards share substantially a same circuit configuration and components. The ECG circuit board further processes the ECG signal using substantially a same path as each IC circuit board uses to process its corresponding IC signal.

Abstract: Described herein are microelectrode devices to provide localized neural recording or neural stimulation to a neurological target. The device includes a plurality of electrodes disposed along the shafts of deployable flexible pins. The deployable flexible pins are enclosed within an elongated probe shaft and can be expanded from their enclosure. Additionally, a specifically manufactured outer housing can be coupled to at least a portion of the elongated probe shaft. During deployment of the flexible pins the outer housing of the microelectrode device reduces friction between the flexible pins and the probe shaft and reduces delamination of the flexible pins during deployment.

Abstract: A power and data coupling device for medical sensors comprises a first conductive surface integrated into a medical device and configured to couple via an electric field with a second conductive surface. The second conductive surface is translatable with respect to the first conductive surface. Additionally, the first conductive surface is connected to a power source for providing power, through the electric field, to the second conductive surface. The first conductive surface also radiates a time-varying electric field that is configured to convey power to the second conductive surface. Further, the first conductive surface is connected to a pick-up that is configured to receive signals from the second conductive surface.

Abstract: Study of intracardiac electrograms (IEGMs) during atrial fibrillation (AF) provides clinically significant information that can be used in ablation therapy. Methods include determining a regional feature, e.g., dominant frequency (RDF), which encompasses the relationship between simultaneously recorded electrodes and identifies the feature components of a region, rather than the feature of a single electrode. Methods employing the regional feature may be used to identify and characterize variation and disorganization in wavefront propagation or wave breaks (WBs) at each recording site, and may be used to direct catheter ablation therapy.

Abstract: A device and method for guided insertion of microelectrodes into tissue, the device involving a flexible optical fiber for optical coherence tomography imaging, a metal layer coating the optical fiber for recording electrical signals and an outer insulation layer coating the metal layer along the optical fiber length, and the method involving inserting an optical fiber coated with a metal layer and further coated with an insulation layer into a tissue, collecting intraoperative image data through the optical fiber by optical coherence tomography, receiving the image data on a computer and displaying the image on a monitor, using the image data to determine a location in the tissue, receiving an electrical nerve signal through the metal layer, and measuring the electrical nerve signal on an electro-physiological recording system.

Abstract: Intracardiac electrograms are recorded using a multi-electrode catheter and respective annotations established. Within a time window a pattern comprising a monotonically increasing local activation time sequence from a set of electrograms from neighboring electrodes is detected. The set is reordered and displayed for the operator.

Abstract: An electrode support structure assembly is provided comprising an electrode support structure including a plurality of splines. Each of the plurality of splines can have a proximal end portion and a distal end portion. The assembly further comprises a first element defining an axis and comprising an outer surface. The outer surface comprises a plurality of slots configured to receive the distal end portion of each of the plurality of splines. The first element is configured such that the distal end portion of each of the plurality of splines may move with respect to each slot. In accordance with some embodiments, the distal end portion of each of the plurality of splines comprises a section configured for engagement with the first element, wherein the section comprises a shoulder.

Abstract: A device includes a handle, an expandable structure including a plurality of splines extending from a proximal hub to a distal hub, a first electrode on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub. The expandable structure has a collapsed state and a self-expanded state. The handle is configured to retract the shaft. Retracting the shaft may expand the expandable structure outward of the self-expanded state.

Abstract: A medical device has a distal member with a configuration that can be changed by means of a control handle with a control assembly employing a rotational cam, a shaft, and a pulley, where the rotational cam is rotationally mounted on a portion of the control handle for rotation by a user. The rotational cam operates on the shaft to move it proximally or distally depending on the direction of rotation which in turn rotates the pulley to draw or release a puller wire to change the configuration of the distal member of the medical device. The shaft is oriented along a diameter of the control handle. The shaft has two ends which extends through two axial guide slots in the portion of the control handle to sit two opposing helical tracks formed on inner surface of the rotational cam. The guide slots are parallel with the longitudinal axis of the control handle and therefore maintain the shaft's diametrical orientation as the rotational cam is rotated to move the shaft proximally or distally.

Abstract: A medical device for sympathetic nerve ablation may include a catheter shaft, an expandable member disposed on or coupled to the catheter shaft, and a plurality of elongate electrode assemblies each constructed as a flexible circuit having a plurality of layers. The expandable member may be configured to shift between an unexpanded configuration and an expanded configuration. The plurality of electrode assemblies may be disposed on an outer surface of the expandable member. Each of the plurality of electrode assemblies may include enhanced tear resistance properties such as through the inclusion of a reinforcement structure with one or more of the layers of the electrode assemblies.

Abstract: According to aspects of the present disclosure, a retrieval device may include a sheath, a first drive member in the sheath, and a second drive member in the sheath. The second drive member may be movable relative to the first drive member. An end effector may be retractable into and extendable out of the sheath. The end effector may include a first proximal end portion coupled to the first drive member, a second proximal end portion coupled to the second drive member, and a plurality of legs extending distally from the first and second proximal end portions to a distal tip of the end effector. All of the legs that extend to the distal tip may be fixed together at the distal tip.

Abstract: An elongate medical device may include an elongate body having a proximal end portion and a distal end portion and defining a longitudinal axis extending from the proximal end portion to the distal end portion. The elongate medical device may further include a basket assembly coupled to the distal end portion comprising a plurality of ablation elements, each of the ablation elements configured to ablate a respective target, the basket assembly disposed on a radial exterior of the elongate body. The elongate medical device may further include an imaging transmitter disposed radially-inward of the ablation elements and configured to project imaging energy towards at least one of the respective targets.

Abstract: In one aspect, the present invention relates to a thermocouple device comprising a flexible non-planar substrate, a first printed thermocouple element comprising a first metal containing ink composition applied to the flexible non-planar substrate, and a second printed thermocouple element in electrical contact with the first printed thermocouple element making a thermocouple junction. The second printed thermocouple element comprises a second metal containing ink composition with a Seebeck coefficient sufficiently different from the first metal containing ink composition for the first and second printed thermocouple elements to together produce a thermocouple effect. The present application further relates to medical devices comprising the thermocouple and methods of making such devices.

Abstract: The present disclosure relates to an implantable lead comprising an elongated lead body having at least one lumen therein and at least one through hole, and at least one electrically conductive wire. For at least one of said at least one lumen, a first through hole extends from an outer surface of the lead body into said lumen, and an electrically conductive wire is arranged in said lumen at least on one side of said first through hole. Furthermore, said electrically conductive wire is further arranged in a configuration exiting the lumen via said first through hole and wound around a predefined portion of the outer surface of the lead body.

Abstract: Aspects of the present disclosure are directed to flexible high-density mapping catheters with a planar array of high-density mapping electrodes near a distal tip portion. These mapping catheters may be used to detect electrophysiological characteristics of tissue in contact with the electrodes, and may be used to diagnose cardiac conditions, such as cardiac arrhythmias for example.

Abstract: The present invention is directed to a method of endoscopically ablating/resecting/excluding (A/R/E) the mucosa of the gastric fundus and body. The method of the present invention is intended to cause cellular death to the X/A-like, ghrelin producing and other hormone cells. This is in contrast to present methods to provide only transient ischemia. The use of the method of the present invention results in a more permanent and robust method of reducing ghrelin and other hormone levels. In addition, a method according to the present invention can be used to induce scarring of the gastric fundus which will reduce gastric accommodation of excess food and result in early satiety.

Abstract: An annuloplasty system is provided which comprises an annuloplasty ring assembly (2), at least one sensor (8) and an external monitor (5) or a prompting device. The annuloplasty ring assembly (2) has an interface adapted to establish an operative connection with a manipulator. The manipulator is utilized for manipulating the annuloplasty ring assembly (2). The sensor (8) is configured to detect regurgitation (13, 34). The external monitor (5) or the prompting device is adapted to provide, e.g. display, information based on the detected regurgitation (13, 34).

Abstract: An ablation device including a first electrode, at least one second electrode and a guiding sleeve is provided. The guiding sleeve is sleeved outside the first electrode and the second electrode, so as to fold the second electrode. The guiding sleeve is adapted to move along an axial direction of the first electrode, so as to adjust a length of the first electrode exposed by the guiding sleeve and enable the second electrode to be released and expand in a radial direction of the first electrode.

Abstract: Systems and methods for navigating a catheter and delivering a needle to a desired anatomic location are provided. The system includes an injection catheter that includes a needle slidably exposed from, or retracted into, the catheter lumen. The system further includes a first acoustic marker located at a distal end of the catheter and configured to generate an acoustic signal, and a second acoustic marker located at the distal end of the retractable needle and configured to generate an acoustic signal. The acoustic markers allow, in conjunction with a Doppler ultrasound imaging system, identification and navigation of an injection catheter and delivering a needle to a desired anatomic target location.

Abstract: New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, substernally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.

Abstract: A system and method for automatically identifying a location of focal arrhythmogenic activity are provided. The method includes receiving, via a plurality of electrodes in a heart, a collection of acquisitions, each including a set of electrophysiological (EP) signals measured by the electrodes. A respective direction of arrival (DOA) and a respective distance relative to the electrodes from which the set of EP signals originated are estimated for each acquisition. The acquisitions are aggregated, to form a statistical distribution of the acquisitions as a function of estimated DOA and distance. Using a statistical test, it is checked whether the statistical distribution is consistent, in accordance with a predefined consistency criterion. If the statistical distribution is found consistent, an estimated location in the heart of a focal source of an arrhythmogenic activity that generated the received EP signals is derived from the statistical distribution.

Abstract: Devices and methods for providing neurostimulation to a patient, particularly in trial systems assessing suitability of a permanently implanted neurostimulation, are provided herein. In one aspect, a trial neurostimulation lead includes a coiled conductor coupled to a proximal contact connector having a retention flange that withstands tensile force from tension in the lead so as to maintain the electrical connection during a trial period. In another aspect, a trial neurostimulation system includes a lead extension that includes a regression stopper between the implanted distal connector and proximal lead disposed outside the body to prevent regression of the lead through a secondary incision, thereby preventing infection and facilitating explant of the system. Methods of assembling and utilizing such leads and systems are detailed herein.

Abstract: An electrophysiology catheter with a distal electrode assembly having covered spine carrying a plurality of microelectrodes. One or more spines have preformed configurations including at least a first portion with a first curvature and a second portion with a second curvature, and may include a linear portion. The linear portion may be between the first and second portions. The linear portion may be distal of the first and second portions. One or more spines have a narrower portion so that different portions of the spine can have different flexibility with a degree of independence in flexibility from adjacent portions.

Abstract: The present disclosure relates to a stent delivery system. According to the present disclosure, it is possible to minimize the current flow distance in the in-body by integrally conducting two poles to the electrocautery tip, thus enhancing the treatment stability.

Abstract: A catheter comprising an elongated catheter body, an electrode array distal of the catheter body, the array having a mounting member and at least first and second spine supports. Each spine support includes a base having a planar configuration, and a plurality of spines extending from the base, wherein the first base extends in a first plane and the second base extends in a second plane different from the first plane in the mounting member.

Abstract: A modular multi-electrode structure for use with an electrophysiology device includes a plurality of interconnected, non-conductive, tubular substrates. Each non-conductive, tubular substrate includes an outer surface and a conductor disposed on the outer surface, as well as at least one signal conductor extending along a length of the interconnected plurality of non-conductive tubular substrates. The conductor disposed on the outer surface of each non-conductive tubular substrate is in electrical communication with the at least one signal conductor. In some embodiments, the plurality of non-conductive tubular substrates includes a plurality of non-conductive polymeric substrates. In alternative embodiments, the plurality of non-conductive tubular substrates includes a plurality of non-conductive, unitary molded cylinders.

Abstract: A medical system may include a shaft member and a structure physically coupled to the shaft member. A portion of the shaft member may be sized to be delivered through a bodily opening leading to a bodily cavity. The structure may include at least two flexible couplings, each flexible coupling extending transversely from an intermediate portion of a respective one of at least two elongate members of the structure. The flexible coupling extending transversely from the intermediate portion of a first one of the at least two elongate members forms at least a part of a first closed loop arranged to receive a portion of the flexible coupling of a second one of the at least two elongate members therethrough to limit a spacing between the intermediate portions of the first and the second ones of the at least two elongate members.

Abstract: Described here are devices, systems, and methods for forming a fistula between two blood vessels. The systems may comprise a first catheter including a housing and an electrode having a proximal end and a distal end. The proximal end is fixed relative to the housing and the distal end is longitudinally slidable within the housing.

Abstract: Systems, devices, and methods for electroporation ablation therapy are disclosed, with the device including a set of splines coupled to a catheter for medical ablation therapy. Each spline of the set of splines may include a set of electrodes formed on that spline. The set of splines may be configured for translation to transition between a first configuration and a second configuration. The devices described herein may be used to form a lesion via focal ablation.

Abstract: What is described is an apparatus for intravascular pressure measurement, comprising an elongate body, a first pressure sensor and a centering assembly disposed adjacent the sensor. In one aspect, the elongate body has a uniform diameter from the distal end to the proximal end. In another aspect, the uniform diameter is 0.035 inches or less. In still a further aspect, the elongated body is a catheter having a plurality of reinforcing filaments and the filaments are utilized to electrically connect the sensor to the proximal end.

Abstract: A system includes a display, an input device, and a processor. The processor is configured to present to a user, on the display, a GUI that illustrates multiple electrodes disposed on an expandable frame of a multi-electrode catheter, and indicates which of the electrodes is active and which of the electrodes is inactive. The processor is further configured to (a) receive, via the input device first user input that chooses between a single-electrode-selection mode and a fan-selection mode, (b) when in the single-electrode-selection mode, receive via the input device second user input that specifies for activation or deactivation individual ones of the electrodes, and (c) when in the fan-selection mode, receive via the input device third user input that specifies for activation or deactivation an angular sector including two or more of the electrodes, and activate and deactivate the electrodes responsively to the first, second and third user inputs.

Abstract: Catheter systems include direction-sensitive, multi-polar tip electrode assemblies for electroporation-mediated therapy, electroporation-induced primary necrosis therapy and electric field-induced apoptosis therapy, including configurations for producing narrow, linear lesions as well as distributed, wide area lesions. A monitoring system for electroporation therapy includes a mechanism for delivering electrochromic dyes to a tissue site as well as a fiber optic arrangement to optically monitor the progress of the therapy as well as to confirm success post-therapy. A fiber optic temperature sensing electrode catheter includes a tip electrode having a cavity whose inner surface is impregnated or coated with thermochromic/thermotropic material that changes color with changes in temperature. An optic fiber/detector arrangement monitors the thermochromic or thermotropic materials, acquiring a light signal and generating an output signal indicative of the spectrum of the light signal.

Abstract: Devices and systems for navigation and positioning a central venous catheter within a patient. In an exemplary embodiment of a system of the present disclosure, the system comprises a first pole and a second pole, the first pole and the second pole configured to generate an electric field within a mammalian body sufficient to obtain a plurality of field measurements therein, and an elongated body configured for at least partial insertion into a blood vessel of the mammalian body and advancement through a vasculature, said advancement dependent upon the plurality of field measurements indicative of one or more locations of a portion of the elongated body within the vasculature. In at least one embodiment, the elongated body is configured as a stylet.

Abstract: This disclosure is directed to a catheter having a basket-shaped electrode assembly formed from a plurality of spines, each with a plurality of electrodes. The spines are connected at their distal ends and extend through the catheter body to its proximal end. Each spine may be independently controlled, such as by adjusting its longitudinal position relative to the catheter body to causes it to bow outwards to a greater or lesser degree.

Abstract: A method, including recording parameters indicative of a quality of ablation performed at one or more sites in a region of a human heart, and receiving a set of electrophysiological signals indicative of a wave of electrical activation flowing through the region. The method further includes identifying locations within the region at which the wave is blocked from flowing and estimating confidence levels with respect to a blockage of the wave at the locations in response to the signals and the parameters. The method also includes displaying a map of the human heart including an indication of the confidence levels.

Abstract: An ablation catheter equipped with ablation petals having electrodes that are continuous over an outer circumferential portion of the ablation petals. The ablation catheter can be moved from a rest position, where the petals are housed in an external tubular body, to an operating position, where the petals protrude from the external tubular body.

Abstract: A system and method for obtaining an OIS coordinate frame comprising an electronic control unit configured to determine a local 3D electric field loop, create a zero mean version of E(t) over a depolarization interval, compute an ? value at each of a plurality of time intervals, compute an initial estimate of ? from a cross product of E and the ? value for each of the plurality of time intervals, average the initial estimate of ? from each of the plurality of time for a best estimate of ?, determine a plurality of â(?) values and using the corresponding {circumflex over (n)}(?) values, compute a composite match score, and choose at least one best value for â and a best value for {circumflex over (n)}.

Abstract: A surgical instrument and method of tracking the surgical instrument includes a shaft, a cutting member, and navigation system. The shaft has a shaft lumen, a shaft window, and a shaft edge. The cutting member is disposed within the shaft lumen and is configured to cyclically move from a first position to a second position relative to the shaft. The cutting member includes a cutting window opening, a cutting edge, and a suction lumen to cut the tissue portion with the cutting member in the first position. The navigation system includes a navigation sensor positioned on at least one of the shaft or the cutting member that is configured to be tracked within a patient for identifying a positional movement of the shaft or the cutting member within the patient.

Abstract: A device and method for guided insertion of microelectrodes into tissue is provided. The device includes a flexible optical fiber for optical coherence tomography imaging, a metal layer coating the optical fiber for recording electrical signals and an outer insulation layer coating the metal layer along the optical fiber length. The method includes inserting an optical fiber coated with a metal layer and further coated with an insulation layer into a tissue, collecting intraoperative image data through the optical fiber by optical coherence tomography, receiving the image data on a computer and displaying the image on a monitor, using the image data to determine a location in the tissue, receiving an electrical nerve signal through the metal layer and measuring the electrical nerve signal on a electrophysiological recording system.

Abstract: An electrophysiology catheter with a distal electrode assembly having covered spine carrying a plurality of microelectrodes. The position of the microelectrodes on each spine is staggered relative to microelectrodes on adjacent spines so as to minimize the risk of electrodes on adjacent spines touching each other during use of the catheter. The staggered electrode configuration provides the distal electrode assembly with a greater effective contact surface because the effective concentric electrode arrays is increased or at least doubled.

Abstract: Disclosed are systems, devices and methods for providing proximity awareness to an anatomical feature while navigating inside a patient's chest, an exemplary method including receiving image data of the patient's chest, generating a three-dimensional (3D) model of the patient's chest based on the received image data, determining a location of the anatomical feature based on the received image data and the generated 3D model, tracking a position of an electromagnetic sensor included in a tool, iteratively determining a position of the tool inside the patient's chest based on the tracked position of the electromagnetic sensor, and indicating a proximity of the tool relative to the anatomical feature, based on the determined position of the tool inside the patient's chest.

Abstract: Ablation systems and methods of the present disclosure control lesion depth and width such that, for example, wide and shallow lesions can be formed in target tissue in an anatomic structure of a patient during a medical procedure. Such wide and shallow lesions can be useful for treating, for example, thin tissue such as atrial tissue in atria of the heart of the patient.

Abstract: Various embodiments provide a cardiac mapping method including: generating an activation map of a heart based on electrocardiogram (ECG) data of a heart and a three-dimensional (3D) heart model; performing an electrophysiology (EP) procedure to determine a first pacing location; pacing the heart at the first pacing location using an EP catheter; determining whether the pacing at the first pacing location generates a desired cardiac response; displaying guidance information related to a second pacing location on one or both of the activation map and the internal surface map, when the first pacing location is determined not to generate the desired cardiac response; moving the pacing catheter to the second pacing location, based on the guidance information; and pacing the heart at the second pacing location.

Abstract: Systems and methods for forming a lesion on an endocardial tissue of a patients heart involve placing an ablation assembly inside of the heart and adjacent to the endocardial tissue, and placing a guiding assembly outside of the heart. An ablation assembly includes an ablation element and a first attraction element, and a guiding assembly includes a second attraction element. First and second attraction elements can be attracted via magnetism. Techniques involve forming an ablation on the cardiac tissue of a patient's heart with an ablation element of the ablation assembly. Optionally, techniques may include moving the second attraction element of the guiding assembly relative to the patient's heart, so as to effect a corresponding movement of the ablation element of the ablation assembly.

Abstract: This disclosure is directed to a catheter having a multi-electrode assembly with a high electrode density. The multi-electrode assembly may be a basket-shaped electrode assembly or a brush-shaped electrode assembly each having a plurality of spines. Each spine includes a flexible wire core of a shape memory material. The flexible wires may have variable cross-section s to control the movement and stiffness of the spines.

Abstract: An electrophysiology catheter with a distal electrode assembly having covered spine carrying a plurality of microelectrodes. The spines have nonconductive covers that are reinforced with tensile members, e.g., wires or fibers, that extend (or have portions that extend) longitudinally so as to minimize any elongation of the covers and the microelectrodes carried thereon. The tensile members may also have a length greater than the length of the spines so the proximal portions extend proximally from the spines, through the catheter and at least into the control handle for actuation by an operator for deflecting and moving the spines, like “fingers.

Abstract: Methods, systems, and devices for providing treatment to a tissue in body lumens are described. The system may include a catheter, an expansion member coupled with a distal portion of the catheter, an ablation structure including one or more longitudinal electrode segments, and an ablation structure support coupled to the ablation structure configured to at least partially unfurl as the expansion member expands and furl as the expansion member contracts. The ablation structure may include multiple separately wired and/or separately controlled longitudinal electrodes, longitudinal electrode zones, or both, such that each longitudinal electrode or longitudinal electrode zone may be selectively enabled or selectively disabled. In some instances, one or more springs are coupled to the ablation structure configured to promote unfurl or furl around the expansion member. In some instances, one or more protection elements are be positioned along the catheter.

Abstract: Embodiments of the present disclosure provide for catheters for use in electrical neuromodulation. The catheter of the present disclosure includes an elongate body having a first end and a second end. The elongate body includes a longitudinal center axis that extends between the first end and the second end. The elongate body further includes three or more surfaces that define a convex polygonal cross-sectional shape taken perpendicularly to the longitudinal center axis. The catheter further includes one or more electrodes on one surface of the three or more surfaces of the elongate body, where conductive elements extend through the elongate body. The conductive elements can conduct electrical current to combinations of the one or more electrodes.

Abstract: Ablation systems and methods of the present disclosure are directed toward delivering pulsed radiofrequency (RF) energy to target tissue. The pulsations of the RF energy, combined with cooling at a surface of the target tissue, can advantageously promote local heat transfer in the target tissue to form lesions having dimensions larger than those that can be safely formed in tissue using non-pulsed RF energy under similar conditions.

Abstract: A device for neural prosthetics is disclosed. The device comprises arrays of micro-wires and a control unit. The control unit connects to and communicates with the micro-wires. The ends of the micro-wires serve as microelectrodes. The microelectrodes are in contact with neural tissue. The micro-wires are covered in sheaths made of conformal material. The ends of the micro-wires protrude beyond the ends of the sheaths. This allows the electrodes to be individually positioned on the neural tissue.