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: A delivery and deployment device may include a handle assembly and a shaft extending distally from the handle assembly. A device containment housing may be coupled to a distal region of the shaft and may extend distally therefrom. The distal containment housing may be configured to accommodate at least a portion of the IMD therein. The IMD may, for example, be a leadless pacemaker, a lead, a neurostimulation device, a sensor or any other suitable IMD. A plurality of electrodes may be distributed about an exterior surface of the device containment housing such that at least some of the plurality of electrodes may be positioned to test a potential IMD deployment location before deploying the IMD.

Abstract: Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example method for delivering the implantable leadless pacing device may include distally advancing an intermediate tubular member of a delivery system across the tricuspid valve and into the right ventricle. An outer tubular member of the delivery device may be torqued in a first direction to guide a distal holding section along the ventricular septum. The distal tip of the distal holding section may be releaseably secured to a tissue. After securing the distal tip of the distal holding section, the outer tubular member may be torqued in a second direction opposite to the first direction and the implantable leadless pacing device incrementally deployed.

Abstract: Extraction devices for extracting chronically implanted devices such as leadless cardiac pacemakers (LCP). In some cases, the extraction devices may be configured to cut, tear or ablate through at least some of the tissue ingrowth around and/or over the chronically implanted device such that a retrieval feature on the chronically implanted device may be grasped for removal of the chronically implanted device. Implantable medical devices such as LCPs may include features that facilitate their removal.

Abstract: Catheter and implantable leadless pacing devices, systems, and methods utilizing catheters and implantable leadless pacing devices are disclosed. An example catheter system may include a holding structure extending distally from a tubular member. An implantable device, such as a leadless pacing device, may be located within a cavity of the holding structure. The holding structure may include one or more electrical ports adjacent the proximal end of the holding structure and adjacent or proximal of the proximal end of the implantable device. The electrical ports may provide a conductive pathway extending through the distal structure to allow electrical signals to pass through the distal structure to and/or from the implantable device.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an implantable medical device. The implantable medical device may include an implantable pacing member having a housing and a lead input. A lead may be coupled to the lead input. The lead may be designed to extend along a pericardial space, epicardium, or both and engage a heart chamber. A passageway may be defined along a portion of the length of the lead.

Abstract: Extraction devices for extracting chronically implanted devices such as leadless cardiac pacemakers (LCP). In some cases, the extraction devices may be configured to cut, tear or ablate through at least some of the tissue ingrowth around and/or over the chronically implanted device such that a retrieval feature on the chronically implanted device may be grasped for removal of the chronically implanted device. Implantable medical devices such as LCPs may include features that facilitate their removal.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an implantable medical device. The implantable medical device may include an implantable pacing member having a housing and a lead input. A lead may be coupled to the lead input. The lead may be designed to extend along a pericardial space, epicardium, or both and engage a heart chamber. A passageway may be defined along a portion of the length of the lead.

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 further include a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member. A longitudinally extending groove having a proximal end and a distal end may be disposed in the intermediate hub portion. A first locking mechanism may be configured to releasably couple the intermediate hub portion and the proximal hub portion.

Abstract: Various aspects describe a lead delivery system for percutaneous introduction of a lead to a stimulation site near a neural target, such as the vagus nerve for nerve stimulation. The lead delivery system may include a needle assembly having a needle adapted to cut through tissue and provide initial access into the carotid sheath. The needle may be retracted into the lead delivery system to prevent cutting structures in the carotid sheath. The lead delivery system may also include a dilator assembly having one or more dilators to dilate a path to the stimulation site. The lead delivery system may further comprise a dilator assembly including a retractable needle adapted to cut through tissue. One or more locating elements, alternatively or in addition to one or more imaging elements, may be used on individual components of the lead delivery system for enhanced trackability and locatability within the body.

Abstract: Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.

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 further include a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member. A longitudinally extending groove having a proximal end and a distal end may be disposed in the intermediate hub portion. A first locking mechanism may be configured to releasably couple the intermediate hub portion and the proximal hub portion.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for pacing a HIS bundle of a patient. The apparatuses, systems, and methods may include applying stimulation energy through one or more of a plurality of electrodes to direct a stimulation locus and pace a HIS bundle of a patient.

Abstract: A device configured to deliver and deploy an implantable medical device (IMD) includes a handle assembly and a shaft extending distally therefrom. A device containment housing configured to accommodate the IMD is coupled to the distal region of the shaft. At least one of the shaft and device containment housing includes a compressible region that is configured to compress by an amount that is related to an applied force. The device may include a first position indicator and a second position indicator. An applied force causes the compressible region to compress by an amount that is related to the applied force, causing a change in distance between the first position indicator and the second position indicator and thus providing an indication of the applied force.

Abstract: Devices and methods of use for introduction and implantation of an electrode as part of a minimally invasive technique. An implantable baroreflex activation system includes a control system having an implantable housing, an electrical lead, attachable to the control system, and an electrode structure. The electrode structure is near one end of the electrical lead, and includes a monopolar electrode, a backing material having an effective surface area larger than the electrode, and a releasable pivotable interface to mate with an implant tool. The electrode is configured for implantation on an outer surface of a blood vessel and the control system is programmed to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.

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 a distal extension extending distally from the distal end thereof. The distal extension may include a retractable and/or rotatable distal electrode. The distal electrode may be configured to be delivered to and pace at the Bundle of His. The leadless pacing device may be releasably coupled to an expandable anchor mechanism.

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 a distal extension extending distally from the distal end thereof. One or more electrodes may be supported by the distal extension. The leadless pacing device may be releasably coupled to an expandable anchor mechanism.

Abstract: The disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

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: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an implantable medical device. The implantable medical device may include an implantable pacing member having a housing and a lead input. A lead may be coupled to the lead input. The lead may be designed to extend along a pericardial space, epicardium, or both and engage a heart chamber. A passageway may be defined along a portion of the length of the lead.