Abstract: Systems and methods are provided for delivering closed-loop or partially closed-loop baroreflex activation therapy (BAT) to treat conditions associated with autonomic dysfunction. A pulse generator delivers stimulation while physiological data, such as ECG, heart rate variability, bioimpedance, and physical activity levels, is collected from one or more sensors. The data is analyzed to assess autonomic nervous system activity, and stimulation parameters are dynamically adjusted in response. In some embodiments, adjustments are made on a beat-to-beat basis using ECG input. Artificial intelligence algorithms may be used to predict patient-specific responses, optimize therapy, and evaluate effectiveness. The method may further include integrating patient-reported symptoms, wirelessly transmitting data, or adjusting stimulation duty cycle based on time of day. The system may further incorporate patient-reported symptoms, a clinician dashboard for remote monitoring, and a multi-channel lead.

Abstract: Devices, systems and methods for non-invasive modulation of the baroreflex system of a patient. In embodiments, the present disclosure may be used to measure and monitor baroreflex function for diagnostic purposes in patients acutely or chronically to inform and guide medical treatment, assess disease severity, or assess morbidity/mortality risk. In embodiments, the present disclosure may be used to provide non-invasive baroreflex activation therapy acutely or chronically to treat a variety of disease conditions through rebalancing of the sympathetic and parasympathetic limbs of the autonomic nervous system and their connections to higher brain centers.

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. A system includes an introducer tool including a dilator portion, a carrier portion and a release mechanism, the dilator portion selectively engageable with the carrier portion. The system further includes a lead including a lead body and an electrode structure, the electrode structure including an active side with an electrode disposed thereon, and an inactive side with an element disposed thereon. The introducer tool is configured to be temporarily inserted into a patient over a guidewire, and a portion of the release mechanism is selectively engageable with the element of the electrode structure to retain the electrode structure to the introducer tool.

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: Embodiments of the present invention generally pertain to devices and methods for use in conjunction with implanting a baroreflex therapy system which includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. More specifically, the devices and methods of the present invention allow for a mapping procedure to be conducted as part of the implant procedure prior to fully implanting the baroreflex therapy system.

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: Embodiments of the present invention generally pertain to devices and methods for use in conjunction with implanting a baroreflex therapy system which includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. More specifically, the devices and methods of the present invention allow for a mapping procedure to be conducted as part of the implant procedure prior to fully implanting the baroreflex therapy system.

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: An implantable baroreflex activation device administers a special electrotherapy program that causes the device to apply electrotherapy to limit a rate of change of blood pressure increase associated with a blood pressure surge event such as a morning blood pressure surge (MBPS).

Abstract: Devices, systems and methods are described by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors. A baroreceptor activation device is positioned near a baroreceptor, preferably a baroreceptor located in the carotid sinus. A control system may be used to modulate the baroreceptor activation device. The control system may utilize an algorithm defining a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption. The baroreceptor activation device may utilize electrodes to activate the baroreceptors. The electrodes may be adapted for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.

Abstract: Physiological parameters of a patient can be used to monitor patient status and/or in conjunction with patient therapy. Physiological cycles may be monitored by implanting a monitoring system into the patient, the system including an implantable pulse generator operably connected to a lead implanted on a carotid sinus of the patient, measuring at least one signal indicative of a physiological parameter of the patient along at least two vectors selected from: a first vector defined between a first electrode of the lead and a second electrode of the lead, a second vector defined between the first electrode of the lead and an electrode integrated into an implantable pulse generator, and a third vector defined between the second electrode of the lead and the electrode integrated into the implantable pulse generator, and providing an output indicative of the at least one signal indicative of the physiological parameter.

Abstract: Embodiments of the present invention generally pertain to devices and methods for use in conjunction with implanting a baroreflex therapy system which includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. More specifically, the devices and methods of the present invention allow for a mapping procedure to be conducted as part of the implant procedure prior to fully implanting the baroreflex therapy system.