Abstract: Therapy systems for treating a patient are disclosed. Representative therapy systems include an implantable pulse generator, a signal delivery device electrically coupled to the pulse generator, and a remote control in electrical communication with the implantable pulse generator. The pulse generator can have a computer-readable medium containing instructions for performing a process that comprises collecting the patient status and stimulation parameter; analyzing the collected patient status and stimulation parameter; and establishing a preference baseline containing a preferred stimulation parameter corresponding to a particular patient status.

Abstract: Various aspects of the present subject matter relate to a method. According to various method embodiments, cardiac activity is detected, and neural stimulation is synchronized with a reference event in the detected cardiac activity. Neural stimulation is titrated based on a detected response to the neural stimulation. Other aspects and embodiments are provided herein.

Abstract: A surgical tool configured to facilitate delivery of a neurostimulator to a craniofacial region of a subject includes a handle portion, an elongate shaft having a contoured distal portion, and an insertion groove on the elongate shaft. The elongate shaft is configured to be advanced under a zygomatic bone along a maxillary tuberosity towards a pterygopalatine fossa. The distal portion includes a distal dissecting tip. The insertion groove is configured to receive, support, and guide a medical device or instrument.

Abstract: The present invention is directed to a method of treating a respiratory or pulmonary condition in a patient by transvascular neuromodulation of an adrenal gland or neural structures that innervate the adrenal gland or components thereof. Methods also include implanting a controller in the patient to control delivery of a therapy signal to the patient's adrenal gland. The therapy signal can be an electrical and/or chemical signal.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: The invention relates to a method (200) for conducting a clinical trial with a medical device. The method (200) includes the step (202) of providing a medical device to a trial subject, the medical device being capable of providing an adjustable level of therapy. The method also comprises the step (204) of using the medical device to apply therapy to the trial subject. The method further comprises the step (206) of controlling the application of therapy applied to the trial subject according to a clinical trial design.

Abstract: Methods and apparatus for delivering therapy from an implanted neurostimulator to a patient are provided. One feature is an external controller that acts as a gateway for therapy. The external controller can be a handheld controller that communicates wirelessly with the implanted neurostimulator. In some embodiments, the controller communicates with a database to determine a therapy approval status of the neurostimulator. Therapy can be approved by a physician prescription, or by prepayment, for example. In some embodiments, the neurostimulator is deactivated when no approved therapies remain.

Abstract: A surgical tool configured to facilitate delivery of a neurostimulator to a craniofacial region of a subject includes a handle portion, an elongate shaft having a contoured distal portion, and an insertion groove on the elongate shaft. The elongate shaft is configured to be advanced under a zygomatic bone along a maxillary tuberosity towards a pterygopalatine fossa. The distal portion includes a distal dissecting tip. The insertion groove is configured to receive, support, and guide a medical device or instrument.

Abstract: A neural stimulation system controls the delivery of neural stimulation using a respiratory signal as a therapy feedback input. The respiratory signal is used to increase the effectiveness of the neural stimulation, such as vagal nerve stimulation, while decreasing potentially adverse side effects in respiratory functions. In one embodiment, the neural stimulation system detects apnea and, in response, adjusts the delivery of the neural stimulation pulses and/or delivers a respiratory therapy treating the detected apnea.

Abstract: Various aspects of the present subject matter relate to a method. According to various method embodiments, cardiac activity is detected, and neural stimulation is synchronized with a reference event in the detected cardiac activity. Neural stimulation is titrated based on a detected response to the neural stimulation. Other aspects and embodiments are provided herein.

Abstract: Therapy systems for treating a patient are disclosed. Representative therapy systems include an implantable pulse generator, a signal delivery device electrically coupled to the pulse generator, and a remote control in electrical communication with the implantable pulse generator. The pulse generator can have a computer-readable medium containing instructions for performing a process that comprises collecting the patient status and stimulation parameter; analyzing the collected patient status and stimulation parameter; and establishing a preference baseline containing a preferred stimulation parameter corresponding to a particular patient status.

Abstract: An apparatus (10) for applying stimulation therapy to a patient includes an implantable medical device (20) and a remote controller (50) for inductively powering the medical device and communicating with the medical device. The remote controller (50) includes a feedback portion (220) for helping to establish a communication link between the remote controller and the implantable medical device (20).

Abstract: Various aspects of the present subject matter relate to a method. According to various method embodiments, cardiac activity is detected, and neural stimulation is synchronized with a reference event in the detected cardiac activity. Neural stimulation is titrated based on a detected response to the neural stimulation. Other aspects and embodiments are provided herein.

Abstract: Various aspects relate to a device. Various device embodiments include at least a first and a second transducer, and a controller. The first transducer is adapted to be positioned to direct a first energy wave toward a neural target, and the second transducer is adapted to be positioned to direct a second energy wave toward the neural target. The controller is connected to the transducers to generate the first energy wave with a first predetermined phase and a first predetermined amplitude from the first transducer and to generate the second energy wave with a second predetermined phase and a second predetermined amplitude from the second transducer. The amplitudes are selected so that a neural stimulation threshold is reached only during constructive wave interference. The phases are selected so that the first and second energy waves constructively interfere at the neural target. Other aspects and embodiments are provided herein.

Abstract: Various aspects of the present subject matter relate to a method. According to various method embodiments, cardiac activity is detected, and neural stimulation is synchronized with a reference event in the detected cardiac activity. Neural stimulation is titrated based on a detected response to the neural stimulation. Other aspects and embodiments are provided herein.

Abstract: Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions are disclosed. A method in accordance with a particular embodiment includes selecting a target stimulation frequency that is above a threshold frequency, with the threshold frequency corresponding to a refractory period for neurons of a target sensory neural population. The method can further include producing a patient sensation of paresthesia by directing an electrical signal to multiple sensory neurons of the target sensory neural population at the stimulation frequency, with individual neurons of the sensory neural population completing corresponding individual refractory periods at different times, resulting in an asynchronous sensory neuron response to the electrical signal.

Abstract: Various aspects provide an implantable device. In various embodiments, the device comprises at least one port, where each port is adapted to connect a lead with an electrode to the device. The device further includes a stimulation platform, including a sensing circuit connected to the at least one port to sense an intrinsic cardiac signal and a stimulation circuit connected to the at least one port via a stimulation channel to deliver a stimulation signal through the stimulation channel to the electrode. The stimulation circuit is adapted to deliver stimulation signals through the stimulation channel for both neural stimulation therapy and CRM therapy. The sensing and stimulation circuits are adapted to perform CRM functions. The device further includes a controller connected to the sensing circuit and the stimulation circuit to control the neural stimulation therapy and the CRM therapy. Other aspects and embodiments are provided herein.

Abstract: A neural stimulation system controls the delivery of neural stimulation using a respiratory signal as a therapy feedback input. The respiratory signal is used to increase the effectiveness of the neural stimulation, such as vagal nerve stimulation, while decreasing potentially adverse side effects in respiratory functions. In one embodiment, the neural stimulation system synchronizes the delivery of the neural stimulation pulses to the respiratory cycles using a respiratory fiducial point in the respiratory signal and a delay interval. In another embodiment, the neural stimulation system detects a respiratory disorder and, in response, adjusts the delivery of the neural stimulation pulses and/or delivers a respiratory therapy treating the detected respiratory disorder.

Abstract: An implantable medical device is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The implantable medical device can be a neurostimulator configured to be implanted on or near a cranial nerve to treat headache or other neurological disorders. One aspect of the implantable medical device is that it includes an electronics enclosure, a substrate integral to the electronics enclosure, and a monolithic feed-through integral to the electronics enclosure and the substrate. In some embodiments, the implantable medical device can include a fixation apparatus for attaching the device to a patient.

Abstract: An implantable neurostimulation electrode assembly comprises a first electrode unit and a second electrode unit configured to be arranged in a side-by-side configuration. The first electrode unit includes a dielectric first paddle, a plurality of first electrodes carried by the first paddle, and a guideline. The guideline has a distal section affixed to the first paddle and a proximal section having a length configured to extend externally of a patient. The second electrode unit has a dielectric second paddle and a plurality of second electrodes carried by the second paddle. The second paddle is configured to travel along the guideline and contact the first paddle in the side-by-side configuration. As a result, the first and second electrode units of this embodiment can be passed percutaneously through the same percutaneous entry hole and assembled in vivo at the stimulation site to form a larger paddle-type electrode array without surgical implantation.