Abstract: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

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: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

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: Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a shaft having a proximal end, a distal end, an open channel that extends from near the proximal end to the distal end, and an attachment feature configured to couple to the medical lead. Such an implant tool provides a user with the versatility to use the same implant tool to either pull the lead through a tunnel formed via the implant tool or push the lead through the tunnel via the open channel in the implant tool.

Abstract: A tethering assembly for securing a medical device includes a shaft and a wire that extends in sliding engagement within a proximal lumen, a channel, and a distal receptacle of the shaft. A retainer zone of the shaft, through which the channel extends, stops a transition segment of the wire, which extends between a proximal and a distal segment of the wire, from moving into the shaft receptacle, thereby restraining a distal-most tip of the wire from moving through a distal-most opening of the receptacle. When a projecting member of the device has entered a secure zone of the receptacle, via movement through the distal-most opening and a tapering passageway thereof, the distal-most tip of the wire, which may be spring-biased, can move distally into the passageway so that the tip blocks the projecting member from moving distally, back through the passageway.

Abstract: An improved assembly for securing an implantable medical device for retrieval from an implant site includes a plurality of snares, wherein distal openings of a first snare carrier lumen and a second snare carrier lumen have a pre-set offset established therebetween. First and second snare shafts, to which first and second snare loops are coupled, respectively, extend within the corresponding snare carrier lumens such that each loop is located in proximity to the corresponding distal opening of the lumen. The pre-set offset allows an operator to simultaneously position the snare loops around the device; and, when the operator retracts the snare shafts to collapse the snare loops until the loops fit snuggly around the device, the pre-set offset can help to align the device for retrieval.

Abstract: A medical device lead. The lead includes one or more jacketed conductive elements. The jacket comprises one or more covers. A first cover of polyether ketone (PEEK) is in direct contact with the at least one conductive element. At least one conductive element and a PEEK cover are coiled. The coiled conductive element can substantially retain its original coiled shape.

Abstract: An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Abstract: An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Abstract: The disclosure describes implantable medical systems that respond to occurrence of a lead-related condition by utilizing an elongated coil electrode in defining an alternative pacing therapy vector to maintain optimal drain of an IMD power supply. An exemplary system includes a medical electrical lead having an elongated electrode and an improved sensing and therapy delivery circuitry to provide the alternative pacing therapy vector responsive to the lead-related conditions. The system reconfigures the operation of the sensing and therapy delivery circuitry triggered by the switch to the alternative pacing therapy vector.

Abstract: A conductor for connecting an electrode near a distal end of a medical electrical lead with an implantable medical device connected with a proximal end of the medical electrical lead includes a multi-filar coil wrapped around a central core. The multi-filar coil has an inductance of approximately 0.5 ?H or greater, and the central core is non-conducting and provides reinforcement for the multi-filar coil.

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: 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: Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue.

Abstract: An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.

Abstract: Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.

Abstract: Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.

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: A joint between an insulative sidewall of a medical electrical lead subassembly and an underlying fluoropolymer layer includes an interfacial layer. A first section of the interfacial layer is bonded to the fluoropolymer layer and is formed by a thermoplastic fluoropolymer; a second section of the interfacial layer extends adjacent the first section and is bonded to the insulative sidewall. The insulative sidewall, of the subassembly, and the second section, of the interfacial layer, are each formed from a material that is not a fluoropolymer. A recess is formed in the first section of the interfacial layer and the second section of the interfacial layer extends within the recess.