# US 2013/0158622 A1 · Implantable Device For Facilitating Control Of Electrical Stimulation Of Cervical Vagus Nerves For Treatment Of Chronic Cardiac Dysfunction > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158622 A1 - Document ID: US20130158622A1 - Status: Published application - Kind: A1 - Application number: 13/314,130 - Filed: 2011-12-07 - Published: 2013-06-20 - Earliest claimed: 2011-12-07 - Assignees: Cyberonics, Inc. - Inventors: Imad Libbus; Badri Amurthur; Bruce H. KenKnight - Web page: https://patentgrep.com/patent/US20130158622A1 ## CPC - A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile} - A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract An implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction is provided. A stimulation therapy lead includes helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath, and a set of connector pins electrically connected to the helical electrodes. A neurostimulator includes an electrical receptacle into which the connector pins are securely and electrically coupled. The neurostimulator also includes a pulse generator configured to therapeutically stimulate the vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials. Finally, the neurostimulator includes a programmable switch configured to alter the triggering of the bi-directional action potentials in response to a magnetic signal received from outside the housing. ## Claims ### Claim 1 An externally-controllable vagus nerve neurostimulator for treating chronic cardiac dysfunction, comprising: an implantable neurostimulator comprising: a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers in both afferent and efferent directions of a cervical vagus nerve through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead; and a programmable switch configured to control the pulse generator in response to a remotely-applied magnetic signal. ### Claim 2 (depends on 1) A neurostimulator according to claim 1, wherein the pulse generator is further configured to suspend the electrical therapeutic stimulation for a fixed period of time in response to the magnetic signal. ### Claim 3 (depends on 2) A neurostimulator according to claim 2, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time. ### Claim 4 An externally-controllable implantable device for treating chronic cardiac dysfunction, comprising: an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of a cervical vagus nerve in continuous alternating cycles of stimuli application and stimuli inhibition; a cervical vagus nerve stimulation therapy lead electrically coupled to the pulse generator and terminated by a pair of helical electrodes through which the therapeutic electrical stimulation is delivered to the cervical vagus nerve; and a programmable switch configured to control the therapeutic electrical stimulation via the pulse generator in response to an external magnetic signal. ### Claim 5 (depends on 4) An implantable device according to claim 4, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals and to suspend the electrical therapeutic stimulation for different durations of fixed periods of time in response to the respective magnetic signal. ### Claim 6 An implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, comprising: a cervical vagus nerve stimulation therapy lead, comprising: a pair of helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath of a patient; and a set of connector pins electrically connected to the helical electrodes by an insulated electrical lead body; and a neurostimulator powered by a primary battery and enclosed in a hermetically sealed housing, further comprising: an electrical receptacle comprised on an outer surface of the housing into which the connector pins are securely and electrically coupled; a pulse generator configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to restore autonomic balance at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of the vagus nerve to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials; and a programmable switch configured to alter the triggering of the bi-directional action potentials by the pulse generator in response to a magnetic signal received from outside the housing. ### Claim 7 (depends on 6) An implantable device according to claim 6, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time in response to the magnetic signal. ### Claim 8 (depends on 7) An implantable device according to claim 7, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time. ### Claim 9 (depends on 6) An implantable device according to claim 6, wherein the pulse generator is further configured to either reset or test the pulse generator in response to the magnetic signal. ### Claim 10 (depends on 6) An implantable device according to claim 6, further comprising: a patient magnet configured to provide the magnetic signal when placed outside the patient's body in proximity to the neurostimulator. ### Claim 11 (depends on 10) An implantable device according to claim 10, further comprising: a computer system configured to execute a software application that provides guided instructions to the patient in conjunction with use of the patient magnet on the neurostimulator. ### Claim 12 A vagus nerve neurostimulator with autotitration for treating chronic cardiac dysfunction, comprising: an implantable neurostimulator comprising: a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers in both afferent and efferent directions of a cervical vagus nerve through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead; and a programmable switch configured to trigger automatic titration of the electrical therapeutic stimulation progressively over a fixed period of time in response to a remotely-applied magnetic signal. ### Claim 13 (depends on 12) A neurostimulator according to claim 12, wherein the pulse generator is further configured to suspend the electrical therapeutic stimulation for a fixed period of time in response to the magnetic signal. ### Claim 14 (depends on 13) A neurostimulator according to claim 13, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals, each magnetic signal corresponding to different durations of the fixed period of time. ### Claim 15 An implantable device with autotitration for treating chronic cardiac dysfunction, comprising: an implantable neurostimulator comprising a pulse generator configured to deliver electrical therapeutic stimulation tuned to restore autonomic balance at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of a cervical vagus nerve in continuous alternating cycles of stimuli application and stimuli inhibition; a cervical vagus nerve stimulation therapy lead electrically coupled to the pulse generator and terminated by a pair of helical electrodes through which the therapeutic electrical stimulation is delivered to the cervical vagus nerve; and a programmable switch configured to trigger automatic titration of the therapeutic electrical stimulation progressively over a fixed period of time in response to an external magnetic signal. ### Claim 16 (depends on 15) An implantable device according to claim 15, wherein the programmable switch is further configured to recognize a plurality of the magnetic signals and to suspend the electrical therapeutic stimulation for different durations of fixed periods of time in response to the respective magnetic signal. ### Claim 17 An implantable device for triggering autotitration of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction, comprising: a cervical vagus nerve stimulation therapy lead, comprising; a pair of helical electrodes configured to conform to an outer diameter of a cervical vagus nerve sheath of a patient; and a set of connector pins electrically connected to the helical electrodes by an insulated electrical lead body; and a neurostimulator powered by a primary battery and enclosed in a hermetically sealed housing, further comprising: an electrical receptacle comprised on an outer surface of the housing into which the connector pins are securely and electrically coupled; a pulse generator configured to therapeutically stimulate the cervical vagus nerve through the helical electrodes in alternating cycles of stimuli application and stimuli inhibition that are tuned to restore autonomic balance at an intensity that avoids acute physiological side affects and with an unchanging cycle not triggered by physiological markers through continuously-cycling, intermittent and periodic electrical pulses simultaneously delivered in both afferent and efferent directions of the vagus nerve to both efferently activate the heart's intrinsic nervous system and afferently activate the patient's central reflexes by triggering bi-directional action potentials; and a programmable switch configured to trigger automatic titration of the bi-directional action potentials into a predetermined set of stimulation parameters progressively over a fixed period of time in response to a magnetic signal received from outside the housing. ### Claim 18 (depends on 17) An implantable device according to claim 17, further comprising: a recordable memory within which is stored the predetermined stimulation parameters set, wherein the pulse generator is further configured to operate under the predetermined stimulation parameters set stored in the recordable memory. ### Claim 19 (depends on 18) An implantable device according to claim 18, wherein the predetermined stimulation parameters set comprises at least one of an amplitude, pulse width, frequency, train length, and duty cycle to define a therapeutic regimen for the patient. ### Claim 20 (depends on 17) An implantable device according to claim 17, wherein the pulse generator is further configured to adjust the bi-directional action potentials to the levels specified in the predetermined stimulation parameters set in increments spread out over time. ### Claim 21 (depends on 17) An implantable device according to claim 17, further comprising: a recordable memory within which is stored a plurality of sets of predetermined stimulation parameters, each set of the predetermined stimulation parameters corresponding to a different magnet signal, wherein the programmable switch is further configured to recognize the different magnetic signals and the pulse generator is further configured to operate under the predetermined stimulation parameters set stored in the recordable memory that corresponds to the magnetic signal recognized by the programmable switch. ### Claim 22 (depends on 17) An implantable device according to claim 17, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time in response to the magnetic signal, after which the triggering of the bi-directional action potentials resumes. ### Claim 23 (depends on 17) An implantable device according to claim 17, wherein the pulse generator is further configured to gradually down titrate the triggering of the bi-directional action potentials in response to the magnetic signal. ### Claim 24 (depends on 23) An implantable device according to claim 23, wherein the pulse generator is further configured to suspend the triggering of the bi-directional action potentials for a fixed period of time and gradually up titrate the triggering of the bi-directional action potentials after the down titration. ### Claim 25 (depends on 17) An implantable device according to claim 17, further comprising: a patient magnet configured to provide the magnetic signal when placed outside the patient's body in proximity to the neurostimulator. ### Claim 26 (depends on 25) An implantable device according to claim 25, further comprising: a computer system configured to execute a software application that provides guided instructions to the patient in conjunction with use of the patient magnet on the neurostimulator.