Abstract: The present disclosure provides electroporation catheters that are capable of forming a loop, generally a circular loop, an oval loop, or like in shape, located on the distal end portion of a catheter shaft within the vasculature of an individual. The electroporation catheters of the present disclosure may be delivered into the vasculature of the individual in a straight conformation and allow for the formation of the loop once positioned in the desired location. Some embodiments of the present disclosure include an electroporation catheter that includes a loop member pull wire in a spiral or helical configuration on an inside surface of the distal end portion of the catheter shaft.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include an implantable lead having a terminal pin, a conductor member configured to rotate in response to rotation of the terminal pin and a coupler arranged within configured to interface with the conductor member and having a rear bearing surface contacting the inner wall of a housing.

Abstract: An example fixation component for an implantable medical device (IMD) includes a base and tines extending from the base and being spaced apart from one another. The tines include a penetrator tine and a protector tine. The penetrator tine includes a curved section defining a deformable preset curvature that extends laterally from a proximal section that is fixed to the base, traversing a longitudinal axis of the fixation component, to a distal section that terminates in an incisive distal end that is configured to penetrate a tissue to form a puncture. The protector tine includes a curved section defining a deformable preset curvature that extends from a proximal section that is fixed to the base, outward from the longitudinal axis, to a distal section that terminates in a non-incisive distal end that is configured to pass through the puncture.

Abstract: An implantable wireless sensor is provided for determining a pressure of a lumen in a body. The sensor comprises a sensor body comprising a plurality of substrates, at least a portion of the substrates comprising a first dielectric material. An LC resonant circuit is contained with the sensor body. A capacitance of the LC resonant circuit is configured to vary in response to changes in pressure in the lumen. A first anchoring element is coupled to a proximal end of the sensor body and a second anchoring element is coupled to a distal end of the sensor body. The first and second anchoring elements are configured to lodge the sensor body within the lumen. A second dielectric material, different than the first dielectric material, is provided over at least a portion of at least one of the plurality of substrates.

Abstract: A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.

Abstract: A leadless pacing device may include a housing having a proximal end and a distal end, and one or more electrodes supported by the housing. The housing may include a body portion and a header. A distal extension may extend distally from the header of the housing, the distal extension including one or more electrodes. The header may include a guide wire port and a guide wire lumen may extend from the guide wire port through the header of the housing and through the distal extension. A fixation member may extend from the header of the housing. The header may be formed from an over mold process.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include an implantable lead. The lead may include a taper or tapered portion and a fixation helix both configured to embed within tissue. In addition, the apparatuses, systems, and methods may include a guide wire configured to obtain and record signals from the heart tissue and facilitate placement of the fixation helix.

Abstract: A stealthy conductor that may be placed inside a fascicle in the peripheral nervous system (PNS) is described. The conductor is placed using a targeted-fascicle or targeted-axon approach to improve specificity and signal to noise ratio (SNR). The conductor is part of a targeted fascicular interface device and is placed using an insertion tool in a manner that reduces nerve damage as compared to conventional systems. The conductor is so small (e.g., <10 ?m diameter) and so flexible (e.g., approximates flexibility of surrounding neuronal material) that biological reactions (e.g., recruitment of macrophages, edema) to the presence of the conductor may be reduced. The targeted fascicular interface device has an insulated portion and a non-insulated portion that may act as an electrode. The insulated portion may include materials that promote healing at the entry/exit site and that adhere to the perineurium.

Abstract: Representative embodiments of the present invention provide for novel, minimally invasive implantable devices and methods for targeted tissue drug delivery of cardiovascular drugs.

Abstract: The capsule includes a tubular body and a front-end unit including an anchoring member for the anchoring of 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, and a disengageable coupling member is adapted to allow this relative rotation when the tubular body receives an external rotational stress, the anchoring member then exerting a reaction torque higher than a predetermined threshold torque, and to prevent the relative rotation in the absence of external rotational stress applied to the tubular body. The coupling member may in particular include, between the front-end unit and the tubular body, a friction interface, with an elastically deformable element applying an axial compression between a bearing face of the tubular body and a support ring integral with the anchoring member.

Abstract: An exemplary electrode lead includes a flexible body formed of a flexible insulating material, an electrode contact disposed on an outer surface of the flexible body, and a strand that includes a first end portion, a second end portion, and a loop that is provided between the first end portion and the second end portion and that protrudes from the flexible body. The loop is configured to engage with a fixing element that is configured to attach the loop to tissue within a recipient to secure the electrode lead within the recipient. Corresponding methods for manufacturing an electrode lead are also described.

Abstract: Implantable lead having an electrode body with a free end and an inner part axially movable or rotatably movable with respect to it and an end on which means of fixation are extendable out of the free end by axially displacing the inner part, the inner periphery of the electrode body having an elastically deformable, peripheral, ring or ring segment-shaped, sealing/resistance element fixed to it. The outer periphery of the inner part having a section whose diameter changes (decreases) in the axial direction; this section passes the sealing/resistance element when the inner part is axially displaced. The inner periphery of the electrode body having a section whose diameter changes (decreases) in the axial direction; this section placed so that the sealing/resistance element passes this section when the inner part is axially displaced, the sealing/resistance element increasingly deformed during axial displacement of the inner part and counteracting movement thereof.

Abstract: A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.

Abstract: An assembly includes a medical device provided with an anchoring member adapted to penetrate tissue of a cavity of the heart. The assembly further includes an implantation accessory including an elongated tubular element provided with a fastening mechanism for handling and guiding the medical device to an implantation site. The fastening mechanism includes an elastic deformable component cooperating with a rigid component, that is able to disconnect the medical device from the tubular element under the effect of a rotation exerted to the tubular element. The elastic deformable component cooperates with the rigid component such that the elastic deformable component exerts on the latter a radial constriction effect, and the elastic component and the rigid component being disconnected under the combined effect of a torsion torque and a traction exerted to the elastic deformable component, to thereby reduce the radial constriction until release of the rigid component.

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. An anchoring member may be coupled to the distal region. One or more anti-rotation members may be fixedly attached to the distal region.

Abstract: A lead for use with cardiac stimulus device with at least two electrodes positioned at a single longitudinal location is provided. The electrodes may include a shocking coil electrode and a sensing and/or pacing ring electrode and may be separated by an insulating element. The at least two electrically insulated electrodes may be electrically isolated and serve separate purposes in the device.

Abstract: An implantable medical device has a housing having a proximal end, a distal end and an outer sidewall extending from the proximal end to the distal end. A fixation sheath includes a housing sheath portion extending along the outer sidewall of the housing, and a fixation member portion extending from the housing sheath portion. The housing sheath portion is advanceable from a first position along the outer sidewall of the housing in which the fixation member portion is retracted toward the proximal end of the housing to a second position along the outer sidewall of the housing in which the fixation member portion is deployed to extend away from the housing distal end for anchoring the implantable medical device at an implant site.

Abstract: An implantable electrical stimulation lead includes a lead body having a proximal portion and a distal portion; electrodes disposed along the distal portion of the lead body; terminals disposed along the proximal portion of the lead body; conductor extending along the lead body and electrically coupling the electrodes to the terminals; and a flexible hinge forming part of the distal portion of the lead body and disposed proximal to the electrodes, wherein the flexible hinge is structurally distinguishable from adjacent regions of the lead body and more flexible than the adjacent regions.

Abstract: Implantable medical devices such as leadless cardiac pacemakers (LCP) may be configured to be delivered to a target location within the heart over a guide wire. In some cases, using a guide wire for delivery facilitates placement of devices in regions not otherwise easily reached. An LCP may include a housing and a wire lumen disposed relative to the housing. The wire lumen may be configured to allow the LCP to slide over a guide wire. In some cases, the guide wire may include a guide wire electrode that may be used to test potential implantation sites.

Abstract: The disclosure is directed to securing electrodes of a medical lead adjacent to a target tissue site. The medical lead may include one or more threaded fixation structures disposed circumferentially about the outer surface of the lead body, or elongated member, that resembles a “screw” or “auger.” During implantation, a clinician may rotate the entire lead to “screw” the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration and improper therapy and provide a fine adjustment for depth of placement. The threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes.

Abstract: A system applies and senses electrical energy to and from tissue within a patient's body. The system includes a steerable delivery catheter, housing a flexible shaft and an electrical generator disposed on or embedded within the flexible shaft. Electrodes coupled to the shaft self-expand radially from a compressed position to an expanded position once the delivery catheter is withdrawn, thereby contacting a wall of the tissue of the patient's body to conduct electrical or other signals. The system may be inserted into the coronary sinus and tributary vein to provide physiological pacing to the His bundle and left ventricle. Further, the system provides for controlled passive transmission of normal electric impulses from the atria to the His bundle and ventricles without the need for an embedded generator.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: Embodiments include an implantable electrical line with at least one helically wound electrical conductor, an electrically conductive sleeve electrically connected to the electrical conductor, and an electrical filter. The electrical filter is arranged between a proximal and a distal longitudinal portion of a helix formed by the at least one helically wound electrical conductor as viewed in a longitudinal direction of the implantable electrical line, and is also arranged within the electrically conductive sleeve as viewed in a radial direction of the implantable electrical line.

Abstract: A secondary drive coupling may comprise at least one coupling member having a first mating portion and a second mating portion. The first mating portion is configured to engage a first section of a shaft on one side of a region of weakness of the shaft, whereas the second mating portion is configured to engage a second section of the shaft on an axially opposite side of the region of weakness. Both the first mating portion and the second mating portion are each configured to prevent rotation of the at least one coupling member about the shaft. In another embodiment, the at least one coupling member comprises a first coupling member comprising the first mating portion and a first contact surface and a separate, second coupling member comprising a second mating portion and a second contact surface that is configured to engage the first contact surface.

Abstract: Systems, methods, and devices for determining occurrences of a tamponade condition are disclosed. One exemplary method includes monitoring an accelerometer signal of a leadless cardiac pacemaker attached to a heart wall, determining if a tamponade condition of the patient's heart is indicated based at least in part on the monitored accelerometer signal, and in response to determining that the tamponade condition is indicated, providing a notification of the tamponade condition for use by a physician to take corrective action.

Abstract: Various fixation techniques for implantable medical device (IMDs) are described. In one example, an assembly comprises an IMD; and a set of active fixation tines attached to the IMD. The active fixation tines in the set are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from the IMD to a hooked position in which the active fixation tines bend back towards the IMD. The active fixation tines are configured to secure the IMD to a patient tissue when deployed while the distal ends of the active fixation tines are positioned adjacent to the patient tissue.

Abstract: The present disclosure relates to implantable capsules for stimulation. One implantable capsule includes a tubular body and a distal member provided at its distal end with an anchoring device adapted to penetrate into a tissue of a wall of an organ of a patient and a distal electrode, the body accommodating a set of functional elements of the capsule and including a proximal electrode. The capsule includes an electrically insulating member between the body and the distal member to isolate the distal member of said body.

Abstract: A medical probe includes a distal end and an elongate body for insertion into an organ of a patient. The distal end is connected to the elongate body and includes multiple arms that, when inserted into the organ, extend to form multiple respective spirals each having electrodes disposed thereon.

Abstract: A method of implanting a lead in the left heart cavity includes introducing the lead into the right heart cavity. The lead includes a lead body having a deformable sheath, a proximal end having an electrical connector, a distal end including a projecting helical screw electrode, and a conductor extending along the sheath, electrically connecting the electrical connector and the helical screw. The method further includes positioning the distal end of the lead to abut a septum wall between the right and left heart cavity. The electrical connector is connected to an RF puncture generator and RF energy is applied to the screw while providing rotational movement to the screw for advancement through the septum wall. The method further includes positioning the screw at a target stimulation site in the left heart cavity and providing rotational movement to the screw to anchor the lead at the target site.

Abstract: In one example, a leadless implantable medical device (LIMD) generates a cathodal stimulation pulse with anodal recharge for delivery to patient heart tissues using the tip electrode and the anode electrode. The LIMD then verifies capture of the cathodal stimulation pulse and, if capture is not verified, delivers a cathodal backup stimulation pulse with anodal recharge using the tip electrode and the anode electrode. Automatic capture verification is thereby provided within an LIMD to allow for a reduction in the magnitude of stimulation pulses and to extend the lifetime of the device. In one particular example, the anode is a middle portion of a cylindrical case with a surface area sufficient to prevent anodal stimulation. Other portions of the case are coated with an electrically insulating material to render those portions substantially electrically inert. A voltage halver may be used to further reduce power consumption.

Abstract: Apparatus for neuromuscular electrical stimulation and methods for anchoring the same are provided. The apparatus may include an elongated member having one or more electrodes disposed at the distal region of the elongated member and at least one fixation element disposed at the distal region of the elongated member. The fixation element may be shaped and sized to be deployed between tissue layers, such as muscle layers, without damaging the tissue layers so as to secure the one or more electrodes in or adjacent to a desired anatomical site within a patient. An additional fixation element may be disposed at the distal region of the elongated member so that tissue, such as a muscle, may be sandwiched between the fixation elements without damaging the tissue.

Abstract: An assembly includes a medical device provided with an anchoring member adapted to penetrate tissue of a cavity of the heart. The assembly further includes an implantation accessory including an elongated tubular element provided with a fastening mechanism for handling and guiding the medical device to an implantation site. The fastening mechanism includes an elastic deformable component cooperating with a rigid component, that is able to disconnect the medical device from the tubular element under the effect of a rotation exerted to the tubular element. The elastic deformable component cooperates with the rigid component such that the elastic deformable component exerts on the latter a radial constriction effect, and the elastic component and the rigid component being disconnected under the combined effect of a torsion torque and a traction exerted to the elastic deformable component, to thereby reduce the radial constriction until release of the rigid component.

Abstract: An intracardiac capsule comprises a cylindrical body having an atraumatic rounded surface and a helical anchoring screw integral with the cylindrical body. The helical anchoring screw is able to penetrate tissue of a wall of the heart and is configured to provide temporary attachment, in rotation and in translation, of the capsule to an implantation site. The helical anchoring screw surrounds at least a portion of the length of the cylindrical body forming a contact region intended to come into contact with the wall of the cavity of the heart. Over the length of the contact region, the external diameter of the cylindrical body is less than the inner diameter of the helical anchoring screw, so as to leave a free gap there between. The helical anchoring screw is secured to the cylindrical body near the proximal end of the contact region, and extends freely to the opposite distal end.

Abstract: A system implantable in the coronary venous system, including a pacing lead with an anchoring screw is disclosed. The system includes a stimulation lead (10) for stimulating a left heart cavity of a patient, and a removable catheter (26) for implanting the lead. The lead (10) has at least one stimulation electrode having an anchoring screw (14) that penetrates into the epicardial tissue of the patient. The catheter tube (26) is a pre-shaped tube with two curvatures in the absence of stress. The two curvatures are inscribed in two separate surfaces (38, 40) for self-orientating the distal end of the catheter tube into the target vein and maintaining the axis of the anchoring screw towards the epicardial wall during the screwing of the lead head.

Abstract: A device for positioning an electrode in tissue includes: a lead body having a distal portion; an electrode array coupled to the lead distal portion; an anchoring element having an anchor tip and being operable in a first configuration in which the anchor tip is retracted within the lead and in a second configuration in which the anchor tip is extended outside the lead and configured to fixate within the tissue; and a displacement mechanism that is actuated to bias the electrode array or the anchoring element toward the tissue. A method for positioning an electrode in tissue includes: navigating, to the tissue, a lead with an electrode array, an anchoring element with a distal anchor tip, and a displacement mechanism; biasing the electrode array and anchoring element towards the tissue with the displacement mechanism; and deploying the anchoring element, and verifying fixation of the anchor tip within the tissue.

Abstract: An implantable medical device includes a lead body having a distal end and a proximal end, a lumen and at least one lead wire extending through the lumen. The lead wire has an outer surface and a polymeric coating on at least a portion of the outer surface of the lead wire. The coating includes a first structure having a first end proximate the outer surface of the lead wire and a second end opposite the first end. The second end is movable relative to the first end and relative to the lead wire.

Abstract: A medical device includes a tubular body having a distal end and a proximal end, a lumen extending through the tubular body from the distal end to the proximal end, a wire extending through the lumen from the distal end to the proximal end, and a polymeric coating. The wire has an outer surface. The polymeric coating is on at least a portion of the outer surface of the wire. The coating comprises a bulk material and a plurality of flexible microstructures disposed on the bulk material. The microstructures extend outwardly from a surface of the polymeric coating.

Abstract: An implantable lead assembly is provided that comprises a lead body having a proximal end portion and a distal end portion, and having a length extending there between. A plurality of electrodes are disposed along the lead body. A plurality of cable conductors are contained within the lead body, the conductors extending from the electrodes to the proximal end portion. A lead connector is provided at the proximal end portion. The lead connector includes a connector pin configured to mate with a corresponding header contact; a first termination pin coupled to one of the plurality of cable conductors; a collar coupler securely and electrically coupling the connector pin and first termination pin in an axially offset alignment with one another; and a body segment that is elongated along a longitudinal axis and extends between a header mating face and a lead mating end.

Abstract: A haptic feedback device including a dual coil linear solenoid is provided. The dual coil linear solenoid construction provides a sense of a pulling force in an opposite direction from a pushing force sensed in the player's hand. A dynamic current source for each coil is disposed to generate dynamic magnetic flux in each coil, whereby a dynamic bi-directional force is exerted on the plunger. A plunger position controller controls the position of the plunger, whereby the plunger position controller applies a dynamic bi-directional force on the plunger to move the plunger to a target position based on the current position of the plunger detected by a plunger position sensor. The haptic feedback device is incorporated into a game controller. Video or arcade games incorporating the feedback device are also disclosed.

Abstract: A method of determining body position uses ECG sensors at fixed positions, not fixed to the patient. The ECG signals recorded from the sensors are used to detect body position, using the variation of ECG potential over the surface of the body. The results may be processed by measuring artifacts related to the angle between the sensors and the heart, in particular the polarity of the QRS complex. The sensors may be fixed on the upper surface of a bed and used to measure sleep position.

Abstract: In accordance with one embodiment, a leadless implantable medical device (LIMD), compromises a hermetic housing that has a distal portion and proximal portion. An electrode is proximate to the distal portion. An electronics package is disposed in the housing, in which the electronics package is configured to generate and deliver stimulation signals to the electrode. A fixation mechanism is disposed on the distal portion of the housing. A torque mechanism is disposed on the proximal portion of the housing. The torque mechanism has a tool engagement element movably coupled to the housing. The tool engagement element has a rotational force applied thereto during implant. The torque mechanism includes a torque limiter that maintains a fixed relation between the tool engagement element and the housing when in an engaged state. The torque limiter changes from the engaged state to a disengaged state when the rotational force exceeds a predetermined torque limit.

Abstract: The invention relates to an implantable capsule, particularly an autonomous capsule of cardiac stimulation, including a tubular body provided at the distal end of an anchoring element with a helical screw adapted to penetrate tissue a wall of an organ of a patient, the body housing a set of functional elements of the capsule. It includes, in an annular area surrounding the base of the screw recessed arrangements defining a set of flush tips oriented in a circumferential direction opposite to that of the screwing, to avoid the unscrewing of the capsule.

Abstract: A medical stylet for guiding a lead includes a first elongate member for attachment of the lead to the target tissue, a second elongate member to reshape the lead. The first elongate member of the medical stylet includes a proximal end portion, and a distal end portion wherein the distal end portion of the first elongate member includes a tip feature configured to engage the lead on application of torque externally. The second elongate member defines a lumen along its length. The lumen of the second elongate member can be configured to enclose at least a portion of the first elongate member. The second elongate member can have a pre defined shape. The pre defined shape of the second elongate member allows the lead to be reshaped when inserted into the lead, this reshaped lead now can be guided to an anatomical pass way.

Abstract: A lead adapted to be steerable during insertion into an animal body includes the following. A structure substantially defining at least one principal planar surface, the structure having a proximate end and a distal end. The structure includes a tip portion on the distal end, and a body portion, with the tip portion being flexible in directions substantially parallel to said at least one principal planar surface. A shape of the tip portion is changeable, and an end of the tip portion traces a path within a plane substantially parallel with the at least one principal planar surface. At least one electrode is connected with said structure.

Abstract: An implantable medical device includes an actuator and/or sensor portion to be fixed to bodily tissue by means of a fixation mechanism, to act on the tissue and/or to detect a signal from the tissue, wherein at least one detector element, preferably a plurality of detector elements, adapted for detecting the close proximity of bodily tissue, is arranged on the actuator and/or sensor portion of the device, and an output of the or each detector element being connected or connectable to a detection signal evaluation unit for deriving a fixation state verification from detection signals provided by the or each detector element.

Abstract: A medical device configured to be secured to an individual may include a housing containing one or more electrical components, and one or more leads electrically connected to the housing. Each lead may include an insulating jacket that surrounds a central core including one or more conductors, and at least one pressure-resisting member integrally formed with one or both of the insulating jacket or the central core. The pressure-resisting member is configured to resist one or more forces exerted into the central core. For example, the pressure-resisting member may include one or more of a suture-anchoring member or a lead-strengthening member.

Abstract: A wireless electrostimulation system can comprise a wireless energy transmission source, and an implantable cardiovascular wireless electrostimulation node. A receiver circuit comprising an inductive antenna can be configured to capture magnetic energy to generate a tissue electrostimulation. A tissue electrostimulation circuit, coupled to the receiver circuit, can be configured to deliver energy captured by the receiver circuit as a tissue electrostimulation waveform. Delivery of tissue electrostimulation can be initiated by a therapy control unit.

Abstract: Described is a medical device lead including a lead body having a conductor lumen including an inner surface. The lead also includes a conductor assembly extending through the conductor lumen; the conductor assembly comprising a conductor member and an outer insulative layer; and an electrode coupled to the conductor cable. The outer insulative layer includes a textured external surface that reduces the coefficient of friction between the outer insulative layer and the inner surface of the conductor lumen through which the conductor assembly extends. Methods of forming the conductor assembly are also described.

Abstract: A leadless intra-cardiac medical device senses cardiac activity from multiple chambers and applies cardiac stimulation to at least one cardiac chamber and/or generates a cardiac diagnostic indication. The leadless device may be implanted in a local cardiac chamber (e.g., the right ventricle) and detect near-field signals from that chamber as well as far-field signals from an adjacent chamber (e.g., the right atrium).

Abstract: A medical electrical lead and methods of implanting medical electrical leads in lumens. Leads in accordance with the invention employ preformed biases to stabilize the lead within a lumen or lumen and to provide feedback to lead implanters. In some embodiments, a preformed bend in the lead may assist an implanter with orienting the lead within a lumen.