Implantable neurostimulator-implemented method for managing bradycardia through vagus nerve stimulation

• US 8,688,212 B2
• Filed: 07/20/2012
• Issued: 04/01/2014
• Est. Priority Date: 07/20/2012
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Libbus, Imad, Amurthur, Badri, Kenknight, Bruce H.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): PHAM, MINH DUC GIA
• Application Number:
  US13/554,656
• Publication Number:
  US 20140025132A1
• Time in Patent Office: 620 Days
• Field of Search: 607 16- 17
• US Class Current: 607/17
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

A method for managing bradycardia through vagus nerve stimulation is provided. An implantable neurostimulator configured to deliver electrical therapeutic stimulation in both afferent and efferent directions of a patient'"'"'s cervical vagus nerve is provided. An operating mode is stored, which includes parametrically defining a maintenance dose of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses. The maintenance dose is delivered via a pulse generator through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle. The patient'"'"'s physiology is monitored, and upon sensing a condition indicative of bradycardia, the delivery of the maintenance dose is suspended. A progressively increasing amount of time is spent waiting via a controller and, upon sensing a condition indicative of an absence or termination of the bradycardia, a progressively increasing partial maintenance dose is delivered via the pulse generator.

Claims

1. An implantable neurostimulator for managing bradycardia through vagus nerve stimulation, comprising:

an implantable neurostimulator configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation in both afferent and efferent directions of action potentials within neuronal fibers comprising a cervical vagus nerve of a patient, further comprising;

an internal recordable memory configured to store an operating mode of a pulse generator, comprising parametrically defining maintenance doses of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses;

the pulse generator configured to therapeutically deliver the maintenance doses to the vagus nerve through a pair of helical-electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle;

a physiological sensor configured to monitor the patient'"'"'s physiology, and upon sensing with the physiological sensor a condition indicative of bradycardia, suspend the delivery of the maintenance doses by the pulse generator to the vagus nerve; and

a controller configured to wait a progressively increasing amount of time, each progressively increasing amount of time having a time period greater than a time period of an initial delay, and, upon sensing a condition indicative of an absence or termination of the bradycardia after suspension of the delivery of the maintenance doses, resume delivery of progressively increasing partial maintenance doses to the vagus nerve via the pulse generator, each progressively increasing partial maintenance dose having a duty cycle less than a duty cycle of a full maintenance dose.

2. A neurostimulator according to claim 1, further comprising:

physiological markers of abnormally slow sinus rhythm specified as part of the operating mode stored in the recordable memory as indicative of bradycardia;

an electrode sensor configured to monitor the patient'"'"'s sinus rhythm through at least one of the helical electrodes and the pulse generator; and

the controller is further configured to, upon sensing of the physiological markers of abnormally slow sinus rhythm, trigger the suspension of the delivery of the maintenance dose.

3. A neurostimulator according to claim 2, further comprising:

physiological markers of normal sinus rhythm specified as part of the operating mode stored in the recordable memory as the condition indicative of the absence of bradycardia; and

the electrode sensor is further configured to monitor the patient'"'"'s sinus rhythm through at least one of the helical-electrodes and the pulse generator during the suspension of the delivery of the maintenance doses for the physiological markers of normal sinus rhythm.

4. A neurostimulator according to claim 1, further comprising:

a leadless heart rate sensor configured as part of the pulse generator to sense a patient'"'"'s heart rate in response to the electrical therapeutic stimulation and monitor the patient'"'"'s heart rate;

a threshold heart rate specified as part of the operating mode as indicative of bradycardia; and

the controller is further configured to, upon sensing of the patient'"'"'s heart rate falling below the threshold heart rate, trigger the suspension of the delivery of the maintenance doses.

5. A neurostimulator according to claim 4, wherein:

the controller is further configured to monitor the patient'"'"'s heart rate through the heart rate sensor during the suspension of the delivery of the maintenance doses for the patient'"'"'s heart rate rising above the threshold heart rate.

6. A neurostimulator according to claim 1, wherein:

the controller is further configured to titrate the electrical therapeutic stimulation when suspending or resuming the delivery of the maintenance doses by the pulse generator.

7. A neurostimulator according to claim 1, further comprising:

a magnetically-actuated reed switch configured to control the pulse generator; and

the implantable neurostimulator is further configured to trigger different modes stored in the recordable memory further comprising;

a suspension magnet mode configured to suspend the delivery of the maintenance doses by the pulse generator in response to a suspension magnetic signal remotely applied to the reed switch; and

a stimulation magnet mode configured to trigger the delivery of the maintenance doses by the pulse generator in response to a stimulation magnetic signal remotely applied to the reed switch.

8. A neurostimulator according to claim 1, wherein:

the controller is further configured to, upon sensing the condition indicative of the absence of bradycardia after suspension of the delivery of maintenance doses, set a new initial delay.

9. An implantable neurostimulator-implemented method for managing bradycardia through vagus nerve stimulation, comprising the steps of:

providing an implantable neurostimulator comprising a pulse generator and a recordable memory configured to deliver electrical therapeutic stimulation in a manner that results in creation and propagation in both afferent and efferent directions of action potentials within neuronal fibers comprising;

storing an operating mode of the pulse generator, comprising parametrically defining maintenance doses of the electrical therapeutic stimulation tuned to restore cardiac autonomic balance through continuously-cycling, intermittent and periodic electrical pulses;

therapeutically delivering the maintenance doses to the vagus nerve via a the pulse generator comprised in the implantable neurostimulator through a pair of helical electrodes via an electrically coupled nerve stimulation therapy lead independent of cardiac cycle;

monitoring the patient'"'"'s physiology via a physiological sensor comprised in the implantable neurostimulator, and

upon sensing a condition indicative of bradycardia, suspending the delivery of the maintenance doses by the pulse generator to the vagus nerve; and

waiting a progressively increasing amount of time via a controller comprised in the implantable neurostimulator, each progressively increasing amount of time having a time period greater than a time period of an initial delay and,

upon sensing a condition with the physiological sensor indicative of an absence or termination of bradycardia after suspension of the delivery of maintenance doses, resuming delivery of progressively increasing partial maintenance doses to the vagus nerve via the pulse generator, each progressively increasing partial maintenance dose having a duty cycle less than a duty cycle of a full maintenance dose.

10. A method according to claim 9, further comprising the steps of:

storing one or more physiological markers of abnormally slow sinus rhythm in the recordable memory as indicative of bradycardia;

monitoring the patient'"'"'s sinus rhythm through at least one of the helical electrodes and the pulse generator; and

upon sensing at least one physiological marker of abnormally slow sinus rhythm, triggering the suspension of the delivery of the maintenance dose by the pulse generator.

11. A method according to claim 10, further comprising the steps of:

storing one or more physiological markers of normal sinus rhythm in the recordable memory as the condition indicative of the absence of bradycardia; and

monitoring the patient'"'"'s sinus rhythm through at least one of the helical electrodes and the pulse generator during the suspension of the delivery of the maintenance doses for at least one physiological marker of normal sinus rhythm.

12. A method according to claim 9, further comprising the steps of:

providing a leadless heart rate sensor configured as part of the pulse generator to sense the patient'"'"'s heart rate in response to the electrical therapeutic stimulation;

specifying a threshold heart rate as indicative of bradycardia;

monitoring the patient'"'"'s heart rate through the heart rate sensor; and

upon sensing of the patient'"'"'s heart rate falling below the threshold heart rate, triggering the suspension of the delivery of the maintenance doses.

13. A method according to claim 12, further comprising the step of:

monitoring the patient'"'"'s heart rate through the heart rate sensor during the suspension of the delivery of the maintenance doses for the patient'"'"'s heart rate rising above the threshold heart rate.

14. A method according to claim 9, further comprising the step of:

titrating the electrical therapeutic stimulation when suspending or resuming the delivery of the maintenance doses.

15. A method according to claim 9, further comprising the steps of:

providing a magnetically-actuated reed switch configured to control the pulse generator;

suspending the delivery of the maintenance doses by the pulse generator in response to a suspension magnetic signal remotely applied to the reed switch; and

triggering the delivery of the maintenance doses by the pulse generator in response to a stimulation magnetic signal remotely applied to the reed switch.

16. A non-transitory computer readable storage medium storing code for executing on a computer system to perform the method according to claim 9.

17. A method according to claim 9, wherein:

upon sensing the condition with the physiological sensor indicative of the absence of bradycardia after suspension of the delivery of maintenance doses, setting a new initial delay.