Abstract: A leadless pacing device may include a housing having a proximal end and a distal end, and a set of one or more electrodes supported by the housing. The housing may include a first portion and a second portion, with a guide wire port extending through the second portion. A guide wire lumen may extend through the second portion of the housing and the guide wire port may be located at a proximal end of the guide wire lumen. An exposed electrode may be located on a side of the housing that is opposite a side on which the guide wire port is located. The leadless pacing device may include a fixing member on the housing and extending radially from the housing. The leadless pacing device may further include a proximal member extending proximally from a proximal end of the housing. The proximal member may be elongated.

Abstract: A vascular introducer system includes a first vascular introducer having an elongated first deflectable catheter sheath defining a lumen having an interior surface with an inner diameter. A tubular insert having a polygonal cross-section is associated with the interior lumen of the first catheter sheath. The system includes a second vascular introducer having an elongated second deflectable catheter sheath defining an exterior surface with an outer diameter that is less than the inner diameter of the interior surface of the first catheter sheath.

Abstract: A lead assembly includes a central lead member having a distal portion configured to extend along a longitudinal axis. The lead assembly also includes two or more side lead members disposed around the central lead member. Each side lead member includes a deploying portion extending at an angle away from the longitudinal axis. Each deploying portion has a proximal portion and a distal portion. The distal portion is laterally spaced from the central lead member and extends more parallel to the longitudinal axis than the proximal portion. The lead assembly also includes one or more electrodes attached to the distal portion of the deploying portion of each side lead member. The lead assembly optionally includes a cannula comprising a lumen, an end portion, and a buckler disposed in the lumen on the end portion for deploying the lead members.

Abstract: A surgical instrument and related method includes an instrument body, a guide shaft distally projecting from the instrument body, and a first surgical tool. The guide shaft has a guide sidewall, a guide lumen, and a clearance opening radially extending through the guide sidewall in communication with the guide lumen. The first surgical tool has an elongate body and a distal head configured to deflect relative to the elongate body from a first position to a second position. The distal head in the first position is positioned within the guide lumen along the central axis. The distal head in the second position is deflected from the central axis and extends at least partially through the clearance opening thereby vacating at least a portion of the guide lumen for introducing a second surgical tool through the guide lumen.

Abstract: A method for designing a patient-customized EA or selecting an existing EA that fits the patient best includes segmenting shapes of SOIs of the cochlea in a pre-operative CT image using a shape model; defining a 3D curve of interest within the shape model of the SOIs as a sequence of points-; automatically transforming the defined 3D curve to the pre-operative CT image so as to obtain a structure curve in the cochlea; determining a length and curvatures of the structure curve at the sequence of points; and designing a patient-customized EA or selecting an existing EA based on the determined length and curvatures of the structure curve such that after the EA shape model, which estimates the resting state shape of the EA, is rigidly registered to the structure curve in the cochlea, the EA shape model has a registration error smaller than a preset value.

Abstract: Systems and methods for driving a flexible medical instrument to a target in an anatomical space with robotic assistance are described herein. The flexible instrument may have a tracking sensor embedded therein. An associated robotic control system may be provided, which is configured to register the flexible instrument to an anatomical image using data from the tracking sensor and identify one or more movements suitable for navigating the instrument towards an identified target. In some embodiments, the robotic control system drives or assists in driving the flexible instrument to the target.

Abstract: A method of forming a plurality of lipid bilayers over an array of cells in a nanopore based sequencing chip is disclosed. Each of the cells comprises a well. A salt buffer solution is flowed over the array of cells in the nanopore based sequencing chip to substantially fill the wells in the cells with the salt buffer solution. A lipid and solvent mixture is flowed over the array of cells to deposit the lipid and solvent mixture over at least some of the wells in the cells. A first portion of the cells, each having a lipid bilayer over its well, is detected. A second portion of the cells, each having a lipid membrane but not a lipid bilayer over its well, is detected. An electrical lipid-thinning stimulus is selectively applied to the second portion of the cells but not to the first portion of the cells.

Abstract: Systems for monitoring left atrial pressure using implantable cardiac monitoring devices and, more specifically, to a left atrial pressure sensor implanted through a septal wall are presented herein.

Abstract: A reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof. Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.

Abstract: Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

Abstract: Disclosed herein are systems and methods for insertion tools for implanting electrode leads. In one embodiment, an insertion tool comprises a shaft having an outer cannula and an inner cannula. An actuator may be configured to transition the insertion tool between at least three configurations. In a first configuration, the inner cannula and the outer cannula are configured to receive the lead in the shaft. In a second configuration, the inner cannula and the outer cannula are configured to secure the lead in the shaft. In a third configuration, the inner cannula and the outer cannula are configured to cause the lead to separate from the insertion tool and implant in adjacent tissue.

Abstract: A system includes intracranial electrodes embedded into a cranium, a deep brain stimulation system embedded into the cranium, a brain implantable device embedded into the cranium, and a pulse generator, the deep brain stimulation system and the brain implantable device linked to the intracranial electrodes and to the pulse generator.

Abstract: Implantable leadless pacing devices and medical device systems including an implantable leadless pacing device are disclosed. An example implantable leadless pacing device may include a pacing capsule. The pacing capsule may include a housing. The housing may have a proximal region and a distal region. A first electrode may be disposed along the distal region. One or more anchoring members may be coupled to the distal region. The anchoring members may each include a region with a compound curve.

Abstract: An implantable antibacterial barrier device for an elongated medical device, the elongated medical device configured to extend from a first site, through a second site, to a third site. The implantable antibacterial barrier device includes a housing configured to be disposed at the first site, a working electrode configured to be disposed at the second site, and a reference electrode configured to be disposed at the first site. The housing includes barrier circuitry. The working electrode electrically is coupled to the barrier circuitry. The reference electrode is electrically coupled to the barrier circuitry. The barrier circuitry is configured to selectively maintain the working electrode at a negative electrical potential relative to the reference electrode to form an antibacterial barrier.

Abstract: Implantable electrodes with power delivery wearable for treating sleep apnea, and associated systems and methods are disclosed herein. A representative system includes non-implantable signal generator worn by the patient and having an antenna that directs a mid-field RF power signal to an implanted electrode. The implanted electrode in turn directs a lowerfrequency signal to a neural target, for example, the patient's hypoglossal nerve. Representative signal generators can have the form of a mouthpiece, a collar or other wearable, and/or a skin-mounted patch.

Abstract: The capsule comprises a tubular body and a front-end unit with an helical screw for anchoring the capsule to a wall of a patient's organ. The front-end unit is mobile in relative axial rotation with respect to the tubular body. A disengageable frictional coupling member allows this relative rotation when, for implantation, the tubular body receives an external rotational stress, and that until a predetermined limit torque triggering the disengagement. At explantation, this disengagement is prevented to allow a joint rotation of the tubular body and of the front-end unit and the unscrewing of the helical screw. It is provided for that purpose two conjugated plates facing each other, with flat surfaces such as circular sectors offset in opposite directions with respect to a radial reference plane, in such a way as to form steps providing an anti-disengagement abutment function.

Abstract: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may be configured to enable fluid flushing of the delivery device prior to use, to remove any air from within the device as well as providing the option of fluid flow during use of the delivery device.

Abstract: An ablation instrument comprises an elongate shaft having a cannula channel and a scope channel, and an electrode disposed in the cannula channel. The electrode is slidable between a first position in which a distal end of the electrode is contained within the cannula channel, and a second position in which the distal end of the electrode extends out of a distal opening of the cannula channel. The ablation instrument further comprises a distal head coupled to the elongate shaft and configured for engaging tissue.

Abstract: A lead introducer includes an integrated sheath/needle including a splittable sheath configured to split a into a first portion and a second portion, a needle having a length and a proximal end region, and a hub coupled to the proximal end regions of the splittable sheath and the needle and configured to split into a first portion and a second portion. The needle is permanently attached to either the first portion of the hub or the first portion of the splittable sheath (or both) so that when the hub is split into the first and second portions, the needle remains attached to the first portion of the hub or the first portion of the splittable sheath.

Abstract: Embodiments for crossing an occlusion by controlling a guide with the aid of optical coherence tomography (OCT) data are described. Embodiments include transmitting one or more beams of radiation via one or more waveguides on a flexible substrate within a guide wire. One or more beams of scattered or reflected radiation may be received from a sample via one or more waveguides. Depth-resolved optical data of the sample may be generated based on the received beams of scattered or reflected radiation. The depth-resolved data may be used for determining at least one of a distance between the guide wire and a wall of the artery and a distance between the guide wire and an occlusion within the artery. A position of the guide wire within the artery may then be controlled based on the determined distance or distances.

Abstract: A transport system for delivery or retrieval of a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator transport system includes a docking cap supported by a bearing within a bearing housing. The bearing allows relative rotation between a torque shaft connected to the docking cap and an outer catheter connected to the bearing housing. The bearing housing and the docking cap include respective bearing retainers that constrain the bearing within the bearing housing without a weld attachment. The weldless retainers of the biostimulator transport system provide a robust mechanical securement of the bearing that is not vulnerable to corrosion. Other embodiments are also described and claimed.

Abstract: The present disclosure presents a trajectory array guide system for defining a trajectory to a target location in the brain of a subject and for guiding an elongated tool along the trajectory. The trajectory array guide system can comprise: a base, an array guide, an imaging unit, and an elongated handle configured for connection with a stereotaxic navigation system. The present disclosure presents a method of using a trajectory array guide system for defining a trajectory to a target location in the brain of a subject and for guiding an elongated tool along the trajectory.

Abstract: A lead fixation device for securing a portion of a lead relative to a surface of a skull includes a skull attachment member having an upper surface and a lower surface, a locking member having an upper surface and a lower surface and associated with the skull attachment member, and a passageway associated with the locking member and configured to receive the portion of the lead. The skull attachment member and the locking member are configured to rotate relative to each other to transition the lead fixation device between a closed state wherein the lower surface of the skull attachment member and the lower surface of the locking member are generally aligned in a common plane, and an opened state wherein the lower surface of the skull attachment member and the lower surface of the locking member are not aligned in a common plane.

Abstract: A system for treatment of obstructive sleep apnea (OSA) is described. The system includes an introducer needle having an elongated body. The introducer needle is configured to create an opening in a tongue of a patient for implantation of a lead for treating OSA. One or more electrically conductive areas are located on the elongated body. A medical device is configured to deliver a stimulation signal via the introducer needle through the one or more electrically conductive areas to the tongue of the patient to stimulate one or more motor points of a protrusor muscle within the tongue of the patient.

Abstract: A method for using information of patient-specific cochlea size and/or shape to determine a patient-customized cochlear implant electrode insertion and placement plan includes segmenting shapes of structures of interest (SOIs) of the cochlea in a pre-operative CT image of the cochlea using a shape model; defining a 3D modiolar hugging curve within the shape model of the SOIs as a sequence of points; automatically transforming the defined 3D modiolar hugging curve to the pre-operative CT image so as to obtain a modiolar curve in the cochlea; rigidly registering an EA shape model of the EA to the modiolar curve in the cochlea, thereby placing a resting state shape of the EA within the patient's SOIs such that the EA matches the modiolar curve in the cochlea; and determining a patient-customized insertion plan for electrode placement using the registered EA shape model.

Abstract: An intravascular catheter includes an electrode carrying member. The catheter includes features visible in the fluoroscopic image that allow the practitioner to determine the radial position of the electrode carrying member within a blood vessel, and to confirm that the electrodes are positioned at the desired part of the vessel wall (e.g. against the posterior surface) and at the desired position along the length of the vessel, all without re-orienting the fluoroscope during the course of electrode positioning within the vascular. The features are shaped, formed in patterns, or possess other properties selected so that the appearance of the features on the fluoroscopic image differs depending on the rotational orientation of the electrodes. This can thus be used by the practitioner to determine whether, for example, an electrode carrying member having the features is positioned on the anterior or posterior wall of the blood vessel in which the array is positioned.

Abstract: Methods to generate elongated wires having a metallic substrate thereon and devices comprising the same. In a method of generating a device, the method comprises the steps of applying a first nonconductive coating upon an elongated core body of the device; applying a first conductive coating upon the first nonconductive coating; applying a photoresist coating upon the first conductive coating; directing a laser/light from a laser/light source upon portions of the photoresist coating to cause said portions of the photoresist coating to harden; applying a first chemical to the photoresist coating to remove the photoresist coating that was not hardened by the laser/light; and applying a second chemical to the hardened photoresist coating to expose portions of the first conductive coating previously positioned below the hardened photoresist coating.

Abstract: A lead-implantation tool for implanting a lead into a patient includes an elongated body having a distal portion with a tip configured to separate patient tissue to form, or extend through, a tunnel in the tissue when the body is advanced along the tissue. A lead-retention element is formed along the distal portion of the body and includes a cutout defined along the body with a cutout surface wall inset from the body's outer surface. A protrusion extends outwardly from the cutout surface wall with at least a portion of the protrusion extending towards the tip. The protrusion is entirely inset from, or flush with, the body's outer surface. The protrusion is configured to removably receive and retain a portion of the lead while the distal portion of the body is advanced along the tissue and to separate from the lead as the body is withdrawn from the tissue.

Abstract: It is an object to provide an electrode catheter in which, when a rotational operation portion is operated, the rotational operation portion and an operating wire do not interfere with a lead wire, do not generate noise during the operation, and do not cause damage or breakage of the lead wire even when the operation is repeated. An electrode catheter according to the present invention includes a tube member 10, a handle 20 having a rotational operation portion 23, electrodes 31 attached to the tube member 10, lead wires 41, an electrode connector 50, and operating wires 71 and 72. A proximal end portion 12 of the tube member 10 is inserted from a distal end of the handle 20 to an inside of the handle 20, and extends in the inside of the handle 20 in the proximal end direction beyond the rotational operation portion 23. Side holes 111 and 115 are formed in a pipe wall of the proximal end portion 12 of the tube member 10.

Abstract: Tether apparatus may be used to replace an implanted lead extension with a replacement lead extension without tunneling or the use of tunneling tools.

Abstract: An implantable medical device includes a housing having a proximal end and a distal end. The implantable medical device is placeable on cardiac tissue in the region of the distal end. An anchoring device is fixedly attached to the housing in the region of the distal end. The anchoring device includes at least one anchoring member. The at least one anchoring member includes a first end and a second end opposite the first end. The second end is disposed on the housing. The at least one anchoring member longitudinally extends between the first end and the second end along an axis of extension and is formed by a flat strip which is twisted by a twist angle about the axis of extension between the first end and the second end. A method for manufacturing an implantable medical device is also provided.

Abstract: A device and system are described that are capable of isolating at least one targeted tissue and forming an anastomosis between two internal body structures though a completely endoscopic procedure. Further, the device and system described generally comprise two tubular members that are capable of moving in a telescopic fashion relative to one another. Additionally, a method is described for using the device and/or system to bypass the duodenum from digestion.

Abstract: A system and method for eye treatment. The system and method utilize an electro acupuncture stimulator. The electro acupuncture stimulator includes a positive lead and a negative lead. The system further includes a pair of first needles, a second needle and a diode. The pair of first needles are electrically connected to one of the positive lead and the negative lead. The diode is electrically connected to the other of the positive lead and the negative lead. The second needle is electrically connected to the diode.

Abstract: Implantable device systems include an electrical lead with one or more electrodes and a shield. The shield is attached to the electrical lead with the shield covering a first side of the electrode and extending laterally away from the electrode. The shield directs energy from at least one of the electrodes of the the electrical lead in a direction away from the shield.

Abstract: An implantable leadless pacing device and delivery system may comprise an implantable leadless pacing device and a catheter configured to deliver the implantable leadless packing device to a target location. The implantable device may comprise a power source, circuitry operatively coupled to the power source, a housing at least partially enclosing the circuitry, a first electrode secured relative to and offset from a longitudinal axis of the housing and exposed exterior to the housing, and a fixation mechanism secured relative to the housing. The fixation mechanism may comprise at least one tine configured to move between an elongated delivery configuration and a curved deployed configuration and radially offset from the first electrode. The catheter may comprise a distal holding section defining a cavity configured to receive the implantable leadless pacing device.

Abstract: A stiffener-reinforced microelectrode array probe and fabrication method using wicking channel-distributed adhesives which temporarily adheres a flexible device onto a rigid stiffener for insertion and extraction. Assembly is by dispensing a liquid adhesive into a narrow open groove wicking channel formed on the stiffener so that the adhesive is wicked along and fills the channel by capillary action, and adhering the adhesive-filled bonding side of the elongated section of the rigid substrate to a flexible device.

Abstract: The present invention is directed at minimally invasive systems in which the proximal end portion of the working channel has either zero or a limited range of movement in the lateral direction. A first embodiment has a slidable collar attached to a pair of flanges, wherein movement of the collar is bounded by an annular frame. A second embodiment has a substantially spherical element attached to the tube. A third embodiment has a plurality of caps. A fourth embodiment is adapted for a larger working channel.

Abstract: A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.

Abstract: The present invention provides a guidewire adjuster and a delivery-system control handle provided with the guidewire adjuster. The guidewire adjuster includes a support mechanism which has a lumen for a guidewire to extend therethrough; and a driving mechanism for driving the guidewire to move back and forth in the lumen. The guidewire adjuster is able to drive the guidewire to move with respect to a sheath of the delivery system. The support mechanism is connected to the control handle of the delivery system and forms a lumen for accommodating the guidewire. A proximal end of the sheath together with the stent can be driven to move upwardly, due to the relative movement between the guidewire and the sheath of the delivery system. Therefore, the position of the stent can be adjusted by advancing the guidewire forward when the stent has been deployed at a lower position than expected.

Abstract: Systems and connectors for hemostasis valves and associated methods are disclosed herein. According to an aspect, a connector for a medical device includes a body defining a first opening, a second opening, and a channel. The channel provides passage between the first opening and the second opening. The body is configured to engage an inlet port of a hemostasis valve at the first opening when the body and the hemostasis valve are arranged in one or more positions with respect to each other. The connector also includes a clip attached to the body and configured to fasten the body to the hemostasis valve when the body and the hemostasis valve are arranged in one of the positions.

Abstract: A shield member is placed within a polymer flexible carrier in between a manipulation member used to aid implant of a nerve cuff and the nerve to avoid touching the nerve surface with the manipulation member because the texture or material of the flexible member typically causes more foreign body reaction or other biologic reaction from the nerve and surrounding tissues than the polymer of the flexible carrier itself.

Abstract: A leadless pacing device may include a power supply providing a power supply voltage, a housing having a first end, a second end, and a side extending between the first end and the second end, and a set of electrodes supported by the housing and in communication with the power supply. The housing may be angled to follow a contour of a patient's heart when the housing is positioned within the coronary sinus of the patient's heart. In some cases, an angled portion of the housing may include a smooth-curve. In some cases, an angled portion of the housing may include a first portion of the housing and a second portion of the housing at an angle of less than one-hundred-eighty degrees with respect to the first portion of the housing. One or more of the electrodes may be exposed on a concave side of the angled housing.

Abstract: Nerve cuff deployment apparatuses and methods of using them to deliver a nerve cuff electrode to a target nerve trunk.

Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: Implantation of a cardiac stimulus system using an illuminating catheter system, and devices for such implantation. Multiple catheter systems for allowing for selective visualization of the internal thoracic vasculature are discussed and disclosed. A multiple lumen catheter may be used to selectively direct a contrast agent to a desired portion of the thoracic vasculature which may include the internal thoracic vein(s) and/or one or more intercostal veins.

Abstract: Methods and systems for selecting electrical stimulation parameters for an electrical stimulation device implanted in a patient can use an iterative process for identifying electrodes for stimulation, as well as suitable stimulation parameters. The process begins with an initial set of electrode combinations to identify regions of the nerve or other tissue for stimulation. This leads to selection of other electrode combinations to test, followed by the selection of multiple electrode groups (which can include three or more electrodes) for stimulation.

Abstract: An IMD may include a housing with a controller and a power supply disposed within the housing. A distal electrode may be supported by a distal electrode support that biases the distal electrode toward an extended position in which the distal electrode extends distally from the distal end of the housing and allows the distal electrode to move proximally relative to the extended position in response to an axial force applied to the distal electrode in the proximal direction. In some cases, the distal electrode support may include a tissue ingrowth inhibiting outer sleeve that extends along the length of the distal electrode support and is configured to shorten when the distal electrode moves proximally relative to the extended position and to lengthen when the distal electrode moves back distally toward the extended position in order to accommodate movement of the distal electrode.

Abstract: Methods and systems of making a medical electrical lead type having a set of tines. A system for implantation of a lead medical electrical lead in contact with heart tissue, comprises an elongated lead body; a set of curved tines mounted to and extending from a distal end of the lead body, the tines having a length (dD) and an effective cross sectional area, and a delivery catheter. The delivery catheter encloses the lead body and has a distal capsule portion enclosing the tines. The tines exerting a spring force against the capsule and provide a stored potential energy. The delivery catheter has an elastic, not stiff and low column strength ejection means for advancing the lead and tines distally from the capsule and fixating the tines within the heart tissue, the controllable and the stored potential energy of the tines together provide a deployment energy. The tines when so fixated in the tissue provide a fixation energy. The deployment energy and the fixation energy of the tines are equivalent.

Abstract: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. At least a portion of the lumen of the inner tubular member may be bifurcated to form a first lumen and a second lumen.

Abstract: Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.