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: 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 neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.

Abstract: A neurostimulation lead includes a lead body having a proximal portion and a distal portion and a first conductor extending through the lead body. An electrode cuff can be secured relative to the distal portion of the lead body. The electrode cuff includes a cuff body, a first tendril extending from a first region of the cuff body, a second tendril extending from a second region of the cuff body and a first electrode disposed on the cuff body and electrically connected to the first conductor.

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: 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: Various embodiments concern an implantable lead. The lead can comprise a lead body. At least two conductors can extend within the lead body, such as in respective lumens of the lead body. The lead can comprise at least two electrodes. Each electrode can be connected to a respective one of the at least two conductors. A paddle body can be connected to the lead body. The paddle body can comprise a longitudinal axis that divides the paddle body into left and right sides. The at least two electrodes can be partially embedded within the paddle body. The at least two electrodes can be arrayed along the longitudinal axis. Each electrode can be asymmetric about the longitudinal axis.

Abstract: The present invention provides a cuff electrode assembly for implantation on a target nerve. The cuff electrode assembly can include a resilient cuff body configured to be disposed about the target nerve. The cuff body includes a first end portion having a first free end, and a second end portion having a second free end. The cuff electrode assembly further includes a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that a force applied to urge the first and second arm members toward one another defines an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve. The cuff electrode assembly further includes an electrode oriented to provide electrical stimuli to the target nerve.

Abstract: Various embodiments concern an implantable paddle lead. The paddle can be attached to a distal portion of an elongate lead body. The paddle can comprise a main panel and a ridge that peripherally surrounds the main panel. The main panel can comprise a first face and a second face opposite the first face. One or more electrodes can be exposed on the first face but not exposed on the second face. The paddles can be sutured to anatomical structures. The sutures can be threaded through the main panel but not through the ridge. The paddle can be thicker along the ridge than along the main panel.

Abstract: A system including a mapping device, a stimulator, and a marker. The mapping device includes a plurality of electrodes to be situated on a baroreceptor region of a patient to map baroreceptors in the baroreceptor region. The stimulator is to stimulate selected electrodes of the plurality of electrodes to obtain physiological responses from the patient in response to stimulation of the selected electrodes. The marker is to be attached to the patient to mark a location of at least one of the selected electrodes based on an analysis of the physiological responses from the patient, where the marker is to maintain its location on the patient as the mapping device is removed from the patient.

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: A system for mapping and marking baroreceptors of a patient. The system includes a mapping device, a marker, and a stimulator. The mapping device includes a plurality of electrodes to be situated on the patient. The marker is to be attached to the patient and mark a location of at least one of the plurality of electrodes based on an analysis of patient physiological responses to stimulation of the plurality of electrodes. The stimulator is to divide the plurality of electrodes into a first electrode zone and a second electrode zone and stimulate electrodes in the first electrode zone and the second electrode zone to obtain first patient physiological responses, where one of the first electrode zone and the second electrode zone is selected based on the first patient physiological responses.

Abstract: A suture sleeve for securing an implantable lead with a suture includes an elongate, tubular body having a proximal end portion with a proximal face, a distal end portion with a distal face, and an exterior surface. The suture sleeve also includes a lumen within the tubular body extending from the proximal end portion to the distal end portion, wherein the lumen is sized to receive the implantable lead. The suture sleeve also includes a nonlinear, inner transition region extending from the lumen to at least one of the proximal face and the distal face of the tubular body, wherein the inner transition region is a curvilinear surface or a chamfered edge having an obtuse angle between adjacent surfaces thereof and is adapted to control the radius of curvature of the implantable lead that bends along the inner transition region.

Abstract: The invention describes a cuff electrode assembly and method for implanting that includes a resilient cuff body configured to be disposed about a nerve. The cuff body includes a first end portion and a second end portion. The cuff body can be pre-formed to define a closed configuration having a generally annular cross-sectional shape such that, in the closed configuration, the cuff body extends helically with the first and second end portions overlapping on different planes. The cuff electrode assembly includes a first arm member and a second arm member, each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that force applied to urge the first and second arm members toward one another causes relative deflection of the first end portion and the second end portion to define an open configuration of the cuff body.

Abstract: A medical apparatus comprising an implantable lead and a stylet configured for stimulation of a target region of a patient's nervous system is described. The lead includes a generally tubular lead body, a conductor, and an electrode assembly. The generally tubular lead body has a stylet lumen and a conductor lumen extending through the proximal and distal ends of the lead body. The conductor is enclosed within the conductor lumen. The electrode assembly extends from the distal end of the lead body. The electrode assembly includes a flexible polymeric carrier and an electrode on the carrier and electrically coupled to the conductor. The stylet is sized and shaped to be receivable within the stylet lumen and configured to stiffen and support the lead body. The distal portion of the stylet includes a bend having a predetermined angle of incidence relative to the proximal portion of the stylet.

Abstract: The present disclosure presents methods and apparatuses for mapping a target physiological region, for example, during baroreceptor stimulation therapy. In an aspect, such an example apparatus of the present disclosure may include a surgical instrument configured to be securely coupled to a patient and to allow access to a target physiological region. Furthermore, the example apparatus may include an attachment element coupled to the surgical instrument and configured to releasably engage a lead, stabilize the lead during mapping of the target physiological region, and allow the lead to be repositioned relative to the target physiological region.

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: An electrode structure for an implantable stimulation lead for use in stimulating a target nerve structure within a patient includes a flexible backing defined by a major dimension extending in a direction of a first axis, and a minor dimension extending generally orthogonal to the first axis. The electrode structure also includes a plurality of electrodes coupled to the backing.

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: The invention describes a cuff electrode assembly that includes a resilient cuff body configured to be disposed about a nerve. The cuff body includes a first end portion and a second end portion. The cuff body can be pre-formed to define a closed configuration having a generally annular cross-sectional shape such that, in the closed configuration, the cuff body extends helically with the first and second end portions overlapping on different planes. The cuff electrode assembly includes a first arm member and a second arm member, each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that force applied to urge the first and second arm members toward one another causes relative deflection of the first end portion and the second end portion to define an open configuration of the cuff body.