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.

Abstract: A fixation component includes tines extending from a base portion of the fixation component. Each tine is elastically deformable between a pre-set position and an open position. Each tine includes a hook segment extending from a proximal end near the base portion to a distal end. Each tine also includes a distal segment extending from the distal end of the hook segment to a tissue-piercing tip. When positioned in the pre-set position, the hook segment extends along a pre-set curvature that encloses an angle between 135 degrees and 270 degrees, and the distal segment extends away from a longitudinal axis of the fixation component.

Abstract: Guidewire-management devices and methods thereof are disclosed herein. A guidewire-management device can include a guidewire, a first sleeve, and a second sleeve. The first sleeve can be configured for distally feeding the guidewire out of the guidewire-management device. The first sleeve can also be configured for proximally feeding the guidewire into the guidewire-management device. The second sleeve can be proximal of the first sleeve in the guidewire-management device. The second sleeve can be configured for feeding the guidewire in concert with the first sleeve. At least a length of the guidewire extending between the first sleeve and the second sleeve can be disposed within a sterile barrier configured to maintain sterility of the guidewire. Methods of the guidewire-management devices can include a method of using a guidewire-management device such as the foregoing guidewire-management device.

Abstract: A method for producing cardiomyocyte cells including implanting a substrate within a heart such that a first portion of the substrate is in physical contact with an endocardium and a second portion of the substrate is not in contact with the endocardium, maintaining the first portion of the substrate in contact with the endocardium for a time at least sufficient to form trabecular fibers extending between the endocardium and the second portion of the substrate, cutting away the trabecular fibers from the endocardium, cutting away the trabecular fibers from the substrate, and removing the trabecular fibers from the heart, wherein the trabecular fibers include cardiomyocyte cells.

Abstract: A cardiac lead system is provided. The lead is placed epicardially through the transverse pericardial sinus with integrated curvatures to prevent the lead from slipping out of the transverse pericardial sinus. Interaction with multiple chambers of the heart is facilitated in a single lead, without anchors that embed into the heart wall. Multiple electrodes can be grouped over each targeted heart area to ensure adequate electrical contact.

Abstract: A leadless biostimulator has a housing including an electronics compartment, an electronics assembly mounted in the electronics compartment, a proximal electrode that disposed on and/or integrated into the housing, and an electrical feedthrough assembly. The electrical feedthrough assembly includes a distal electrode and a flange. The flange is mounted on the housing. The distal electrode is electrically isolated from the flange by an insulator and configured to be placed in contact with target tissue to which a pacing impulse is to be transmitted by the leadless biostimulator. A mount is mounted on the flange and thereby mounted on the electrical feedthrough assembly. A fixation element is mounted on the mount and configured to facilitate fixation of the leadless biostimulator to tissue of a patient.

Abstract: This document discusses, among other things, systems and methods for robotically assisted implantation of an implant in a patient. A system includes an external positioning unit configured to engage an elongate member of the implant, and a control console communicatively coupled to the external positioning unit. The control console may have a user interface that enables a user to input motion control instructions. The control console may generate a motion control signal, according to a specific motion control instruction, to control the external positioning unit to propel the implant into a target implant site. The system may be used to robotically control the delivery and positioning of a cochlear implant during a hearing-preservation cochlear implant surgery.

Abstract: A medical device for treating cardiac rhythm disorders, and a cardiac implantation device and a pacing system. The cardiac implantation device includes: a first connecting member having an end configured to be coupled to a pacemaker; and N support struts, each of the N support struts having a proximal end coupled to the other end of the first connecting member. The support struts are provided thereon with anchor(s) configured to secure during implantation. Distal ends of the support struts are free and are able to radiate outwardly or converge inwardly. The pacing system includes the implantation device and a pacemaker. A leadless pacemaker can be implanted into the superior vena cava in order to achieve atrial sensing and pacing. Moreover, the leadless pacemaker can be more easily retrieved after long-term implantation at a high success rate, promoting the application of leadless pacemakers and enhancing patients' use experience.

Abstract: Systems and methods which provide a bulkhead anchor configuration in which an anchor body includes flexure finger members and a radial bulkhead operable in cooperation to impart a radial compressive force to a corresponding lead body are described. A first portion of a bulkhead anchor body may comprise a plurality of flexure finger members disposed in a corolla configuration forming an anchor lumen through which a lead body may be inserted. A second portion of the bulkhead anchor body may comprise a radial bulkhead having a flexure profile configured to operatively engage the flexure finger members. A locking mechanism may be used to retain the first and second portions of the bulkhead anchor in their relative positions such that the radial compressive force is maintained upon the lead body indefinitely.

Abstract: The present invention relates to a magnetic navigation-guided tear-away sheath for cardiac conduction bundle pacing, including a sheath body and a joint fixedly connected to a rear end of the sheath body. The sheath body includes a front flexible section and a rear fixed section, and the front flexible section is freely bendable. An outer surface near a head end of the front flexible section is provided with a plurality of pairs of half-ring magnets, two half-ring magnets in each pair of half-ring magnets are symmetrically disposed and form a ring, and a gap is kept between the two half-ring magnets. The head end of the front flexible section is provided with three electrodes uniformly disposed in a circumferential direction, and the three electrodes can be freely combined two by two, to form three electrode pairs used to record and position an intracardiac potential.

Abstract: A catheter may be adapted to map a chamber of the heart. The catheter may include a magnetic and/or ultrasound sensor for navigation. The body of the catheter may be pliable and configured to form a predetermined shape upon exiting a catheter sheath. Upon exiting the catheter sheath, the catheter body may be configured to form one or more loops, and the loops may be non-overlapping loops. In some examples, the non-overlapping loops may be concentric loops. Alternatively, the catheter body may be configured to form one or more splines. The catheter body may include an embedded electrode assembly. The electrodes of the electrode assembly may be may be arranged in one or more rows and configured to detect a wave front. The electrode assembly may also be configured to generate and activation sequence and determine a direction of an activation source.

Abstract: A retention device for use with an implantable medical device (IMD) may comprise an elongate body including a configured to receive the lead of the IMD. The retention device may also include securing mechanisms coupled to the elongate body and configured to push against tissue of a patient. The securing mechanisms may also include linking elements coupled to the elongate body and a portion of the securing mechanisms.

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

Abstract: Devices and methods for providing neurostimulation to a patient, particularly in trial systems assessing suitability of a permanently implanted neurostimulation. Such trial systems can utilize a trial neurostimulation lead that includes a coiled conductor coupled to a proximal contact connector that is coupled with an external pulse generator. The trial neurostimulation lead can be a coiled conductor of a closed wound configuration that can be stretched to form an open coil portion or gaps between adjacent coils to provide more resistance to migration or regression of the lead.

Abstract: An implantable medical device includes a device housing, a fixation device, a first prong projecting from a proximal end of the device housing and a second prong projecting from the proximal end of the device housing. The second prong is spaced apart from the first prong. The first prong includes a first flange projecting away from a longitudinal axis of the device housing. The second prong includes a second flange projecting away from the longitudinal axis. The first prong and the second prong are configured to extend to a first flange diameter in a relaxed configuration and to extend to a second flange diameter in an expanded configuration.

Abstract: Anchoring mechanisms for an implantable electrical medical lead that is positioned within a substernal space are disclosed. The anchoring mechanisms fixedly-position a distal portion of the lead, that is implanted in the substernal space.

Abstract: A pacemaker has a housing and a therapy delivery circuit enclosed by the housing for generating pacing pulses for delivery to a patient's heart. An electrically insulative distal member is coupled directly to the housing and at least one non-tissue piercing cathode electrode is coupled directly to the insulative distal member. A tissue piercing electrode extends away from the housing.

Abstract: An introducing device for locating a tissue region and deploying an electrode is shown and described. The introducing device may include an outer sheath. An inner sheath may be disposed within the outer sheath. The inner sheath may be configured to engage an implantable electrode. In an example, the inner sheath may comprise a stimulation probe having an uninsulated portion at or near a distal end of the delivery sheath. The outer sheath may be coupled to a power source or stimulation signal generating circuitry at a proximal end. A clinician may control application of the stimulation signal to a tissue region via the outer sheath.

Abstract: An adapter includes a first connector, a second connector, and a circuit that reverses a polarity of a signal received at the first connector. Moreover, a lead includes a connector including a cathode terminal and an anode terminal, an electrode including a tip and a ring, and a circuit that connects the anode terminal of the connector to the tip of the electrode and that connects the cathode terminal of the connector to the ring of the electrode.

Abstract: An illustrative anchoring mechanism is provided for attachment to an implantable subcutaneous lead to facilitate anchoring at the distal tip of the lead. The anchoring mechanism is attached to an opening in a distal portion of a subcutaneous lead prior to implantation. The anchoring mechanism may be designed to avoid covering the sensing electrode of the subcutaneous lead, to prevent interference with sensing. Use of such an apparatus may reduce the number of incisions needed to perform implantation.

Abstract: A retention device for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a configured to receive the lead of the IMD. The retention device may also include securing mechanisms coupled to the elongate body and configured to push against tissue of a patient. The securing mechanisms may also include linking elements coupled to the elongate body and a portion of the securing mechanisms.

Abstract: Medical leads include distal tip anchors that are retained by fixation mechanisms of implantation tools. The fixation mechanism may include a fixed body that has features retaining the distal tip anchor. The fixation mechanism may include a movable body that can apply tension to the distal tip anchor to force the distal tip anchor to be released from the features of the fixed body. The movable body may include an axial portion that is received by an axial hole of the fixed body to allow for axial movement of the movable body to release the distal tip anchor. The fixation mechanism may instead include an elongated flexible body that passes through the distal tip anchor and is attached to the fixed body. Tension applied to the elongated body creates a releasing motion of the distal tip anchor to free the distal tip anchor from the features of the fixed body.

Abstract: Retention devices for use with an implantable medical device (IMD) are disclosed. An illustrative retention device may comprise an elongate body including a bore configured to receive and substantially surround an implantable lead of the IMD and an outer surface configured to receive a suture. The retention device may also include a securing mechanism configured to push against tissue of the patient.

Abstract: An implantable device, comprising: an end section, and at least one or a plurality of anchoring elements connected to the end section for anchoring the end section of the implantable device in the tissue of a patient, the anchoring element(s) extending in an extension direction of the anchoring element(s). The anchoring element(s): has an elastically compressible design; can be arranged in a compressed state in which it is folded toward the end section; and is designed to automatically move into an expanded state in which it projects from the end section at an angle of incidence. The anchoring element(s) comprises at least one first lamella and a second lamella connected to the first lamella, and wherein the two lamellae extend along the extension direction of the anchoring element(s) and include a first angle with one another in a plane perpendicular to the extension direction of the anchoring element(s).

Abstract: Disclosed is an intra-cardiac implant, a device and a method for respectively implanting two connected intra-cardiac implants to two cardiac chambers at one time. The intra-cardiac implant comprises a columnar housing including a sidewall, a first terminal and a second terminal, a first connecting portion located at the first terminal of the housing and configured to connect with the implantation device; and a hook body mounted at the sidewall of the housing and comprising a fixed end on the sidewall and a free end stretching from the fixed end, wherein the hook body is configured to form a clamping structure with the sidewall, the free end comprises a tip on its top for piercing the myocardium, and the intra-cardiac implant is clamped between the hook body and the sidewall, so that the intra-cardiac implant is fixed on the myocardium.

Abstract: Medical leads have one or more openly coiled filars and a distal body coupled to the openly coiled filars. The openly coiled filars provide a lead with compliance and elasticity while the distal body provides the firmness needed for placement and support of the electrodes. The openly coiled filars may transition to a linear distal portion that extends to the distal body, and the distal body may have proximal tines that fold proximally to become adjacent to the linear distal portion of the filars. The openly coiled filars may instead extend to the distal body and the proximal tines may be laterally arced to then fold against the lateral surface of the coiled filars. The tines may fold distally during explantation to allow the distal body to release and exit the body.

Abstract: A distal-end assembly of a medical device, the distal-end assembly includes a flexible substrate and electrical conductors. The flexible substrate is configured to be coupled to a distal end of an insertion tube. The electrical conductors are disposed on the flexible substrate and are shaped to form: (i) one or more electrodes, configured to exchange electrical signals with a proximal end of the medical device, and (ii) one or more printed filters shaped to form at least a resistor, which are disposed adjacently to at least one of the electrodes and are configured to filter signals in a predefined frequency range from the electrical signals exchanged between the at least one of the electrodes and the proximal end.

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: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: A stimulation lead anchoring system includes a lead anchor and a removable inner core. The lead anchor includes an anchor body that includes a lead lumen that extends longitudinally along the anchor body and is configured and arranged to receive a portion of an electrical stimulation lead. The removable inner core includes a core body that includes an inner lumen that extends longitudinally along the core body. The lead anchor and removable inner core are configured and arranged to expand the anchor body when a portion of the core body is inserted into the lead lumen to facilitate receiving the portion of the electrical stimulation lead into the lead lumen and inner lumen and slidably positioning the lead anchor along the lead. The anchor body is configured and arranged to engage the portion of the electrical stimulation lead upon withdrawal of the core body from the lead lumen.

Abstract: A needle-injection catheter includes a catheter body having a distal end, a proximal end, a stiff proximal portion, a flexible distal portion, and a delivery lumen extending therethrough. In a first embodiment, a straight injection needle extends coaxially from a distal tip of the flexible portion of the catheter body, and a plurality of penetration limiting elements positioned circumferentially about a base of the straight injection needle and configured to fold radially inwardly against a shaft of the needle when constrained in a tubular lumen and to extend radially outwardly when unconstrained. In a second embodiment, a helical needle extends from the distal tip of the flexible portion of the catheter body. The helical needle has at least one helical delivery lumen connected to receive an injectable substance from the delivery lumen of the catheter body.

Abstract: Devices and methods for peripheral nerve stimulation with an electrode assembly having a lead body with a tapered transition, at least one anchor, and at least one distal lead configured to connect to the lead body are disclosed.

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

Abstract: Retention devices and methods are provided for drug delivery. The device may include a housing configured for intraluminal deployment into a human or animal subject and at least one reservoir contained within the housing. The at least one reservoir may have an actuation end and a release end and contain at least one drug formulation. A plug may be contained within the at least one reservoir and be moveable from the actuation end toward the release end. The device may also include an actuation system operably connected to the actuation end of the at least one reservoir and configured to drive the at least one drug formulation from the reservoir. The device may also include at least one retention member affixed to the housing and movable between a non-stressed position, a deployment position, and a retention position for retaining the device in an intraluminal location in the subject.

Abstract: Implantation of a cardiac stimulus system into the mediastinum using the ITV. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed using the brachiocephalic vein to access the ITV, with access to the brachiocephalic vein achieved using subclavian vein, using standard visualization techniques. Inferior access may be accomplished inferior to the lower rib margin via the superior epigastric vein. Intercostal access may include creating an opening in an intercostal space between two ribs and advancing a needle using ultrasound guidance.

Abstract: Procedures, implantable wireless sensing devices, and sensor assemblies suitable for monitoring physiological parameters within living bodies. Such sensor assembly includes a sensing device and an anchor for securing the sensing device within a living body. The sensing device comprises a housing having at least one internal cavity and a transducer and electrical circuitry within the at least one internal cavity. The sensing device further comprises an antenna that is within the at least one internal cavity or outside the housing. The housing has at least one additional housing portion in which the transducer, the electrical circuitry, and the antenna are not located. The anchor has a metal portion that surrounds the at least one additional housing portion so as not to surround the transducer, the electrical circuitry, or the antenna.

Abstract: A relatively compact implantable medical device includes a fixation member formed by a plurality of fingers mounted around a perimeter of a distal end of a housing of the device; each finger is elastically deformable from a relaxed condition to an extended condition, to accommodate delivery of the device to a target implant site, and from the relaxed condition to a compressed condition, to accommodate wedging of the fingers between opposing tissue surfaces at the target implant site, wherein the compressed fingers hold a cardiac pacing electrode of the device in intimate tissue contact for the delivery of pacing stimulation to the site. Each fixation finger is preferably configured to prevent penetration thereof within the tissue when the fingers are compressed and wedged between the opposing tissue surfaces. The pacing electrode may be mounted on a pacing extension, which extends distally from the distal end of the device housing.

Abstract: An elongated implantable medical device for delivering electrical stimulation pulses to a patient includes a housing having a housing proximal end and a housing distal end and an electrical conductor having a conductor proximal end and a conductor distal end. The conductor distal end extends from the housing proximal end. The housing has a first fixation force at a first implant site after being implanted in a patient's body, and the conductor proximal end has a second fixation force at a second implant site after being implanted in a patient's body. The second fixation force is different than the first fixation force.

Abstract: A removable navigation system for a medical device configured for insertion within a lumen in a body is provided. The removable navigation system includes a sheath operatively configured to cover at least a portion of the medical device, a positioning sensor affixed to the sheath and a deformable fixation element disposed between the sheath and the medical device. The deformable fixation element is operatively deformed to temporarily fix a position of the medical device relative to the sheath and positioning sensor.

Abstract: An implantable medical device system includes an extracardiac sensing device and an intracardiac pacemaker. The sensing device senses a P-wave attendant to an atrial depolarization of the heart via housing-based electrodes carried by the sensing device when the sensing device is implanted outside the cardiovascular system and sends a trigger signal to the intracardiac pacemaker in response to sensing the P-wave. The intracardiac pacemaker detects the trigger signal and schedules a ventricular pacing pulse in response to the detected trigger signal.

Abstract: Catheter assemblies for neuromodulation proximate a renal artery bifurcation and associated systems and methods are disclosed herein. A catheter assembly configured in accordance with a particular embodiment of the present technology can include a shaft having a proximal portion, a distal portion, and two therapeutic arms extending from the distal portion. The shaft can be configured to deliver the distal portion to a treatment site proximate a branch point or bifurcation in a renal blood vessel. The therapeutic arms can include energy delivery elements that are configured to deliver the therapeutically-effective energy to renal nerves proximate the branch point.

Abstract: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery system may comprise a delivery device, an implantable leadless pacing device, and a tether. The tether may be made of a material which allows for a lubricious, strong, no stretch, no memory tether. The tether may releasably secure the implantable leadless pacing device to the delivery device.

Abstract: An illustrative anchoring mechanism is provided for attachment to an implantable subcutaneous lead to facilitate anchoring at the distal tip of the lead. The anchoring mechanism is attached to an opening in a distal portion of a subcutaneous lead prior to implantation. The anchoring mechanism may be designed to avoid covering the sensing electrode of the subcutaneous lead, to prevent interference with sensing. Use of such an apparatus may reduce the number of incisions needed to perform implantation.

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: Devices and methods are provided for percutaneously treating atherosclerotic plaques within blood vessels. Atherosclerotic plaques cause significant morbidity and mortality by narrowing the arteries, which adversely affects blood flow, and by acting as a source for thrombi and emboli thus causing acute organ ischemia. Current treatments include open surgery with its inherent drawbacks, and stenting, which is less invasive but leaves the plaque material in the artery, which promotes restenosis. The present invention combines the advantages of both approaches. In general, the invention provides tools that enable percutaneously dissecting the plaque from the arterial wall and removing it from the body.

Abstract: Methods of manufacturing implantable electrotherapy leads are disclosed herein. In one embodiment, the lead is manufactured by receiving a length of lead stock, forming an opening in a jacket at an intermediate location, interrupting a selected cable conductor, connecting a crimp connector to a proximal portion of the interrupted conductor at the opening, connecting a conductive element to the crimp connector, and removing at least a segment of a distal portion of the interrupted conductor from a lead body.

Abstract: A method for producing cardiomyocyte cells including implanting a substrate within a heart such that a first portion of the substrate is in physical contact with an endocardium and a second portion of the substrate is not in contact with the endocardium, maintaining the first portion of the substrate in contact with the endocardium for a time at least sufficient to form trabecular fibers extending between the endocardium and the second portion of the substrate, cutting away the trabecular fibers from the endocardium, cutting away the trabecular fibers from the substrate, and removing the trabecular fibers from the heart, wherein the trabecular fibers include cardiomyocyte cells.

Abstract: A fixation mechanism of an implantable medical device is formed by a plurality of tines fixedly mounted around a perimeter of a distal end of the device. Each tine may be said to include a first segment fixedly attached to the device, a second segment extending from the first segment, and a third segment, to which the second segment extends. When the device is loaded in a lumen of a delivery tool and a rounded free distal end of each tine engages a sidewall that defines the lumen, to hold the tines in a spring-loaded condition, the first segment of each tine, which has a spring-biased pre-formed curvature, becomes relatively straightened, and the third segment of each tine, which is terminated by the free distal end, extends away from the axis of the device at an acute angle in a range from about 45 degrees to about 75 degrees.

Abstract: Medical leads have one or more openly coiled filars and a distal body coupled to the openly coiled filars. The openly coiled filars provide a lead with compliance and elasticity while the distal body provides the firmness needed for placement and support of the electrodes. The openly coiled filars may transition to a linear distal portion that extends to the distal body, and the distal body may have proximal tines that fold proximally to become adjacent to the linear distal portion of the filars. The openly coiled filars may instead extend to the distal body and the proximal tines may be laterally arced to then fold against the lateral surface of the coiled filars. The tines may fold distally during explantation to allow the distal body to release and exit the body.

Abstract: A tine portion of an implantable medical device includes a hook segment and a distal segment terminated by a tissue-piercing tip, wherein the distal segment extends from a distal end of the hook segment to the tip. The hook segment, which is elastically deformable from a pre-set curvature, for example, defined by a single radius, preferably tapers from a first width thereof, in proximity to a proximal end thereof, to a smaller, second width thereof, in proximity to the distal end thereof, wherein the tip has a width that is greater than the second width of the hook segment. Alternately, the tine portion may include a hook segment that is defined by two radii and a straight section extending therebetween.