Implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction

• US 8,918,190 B2
• Filed: 12/07/2011
• Issued: 12/23/2014
• Est. Priority Date: 12/07/2011
• 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): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/314,133
• Publication Number:
  US 20130158616A1
• Time in Patent Office: 1,112 Days
• Field of Search: 607/17, 607/40, 607/116, 607/118
• US Class Current: 607/118
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• 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

Abstract

An implantable device for evaluating autonomic cardiovascular drive in a patient suffering from 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. The neurostimulator includes a recordable memory storing a baseline heart rate. The neurostimulator includes an integrated leadless heart rate sensor configured to continually monitor heart rate in light of the baseline heart rate.

Claims

1. A vagus nerve neurostimulator for modulating autonomic cardiovascular drive, comprising:

a pulse generator, wherein the pulse generator generates a pulsed electrical signal comprising;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency of approximately 10 Hz;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

a therapy lead;

an electrode communicatively coupled to the pulse generator via the therapy lead, wherein the electrical signal is applied to a vagus nerve via the electrode to propagate action potentials in both afferent and efferent directions along the vagus nerve at an intensity that avoids acute physiological side effects; and

a leadless heart rate sensor.

2. The vagus nerve neurostimulator according to claim 1, wherein the pulsed electrical signal further comprises a signal ramp-up time.

3. The vagus nerve neurostimulator according to claim 1, wherein the pulsed electrical signal further comprises a signal ramp-down time.

4. The vagus nerve neurostimulator according to claim 1, wherein the duty cycle comprises a value in a range of 5% to 20%.

5. The vagus nerve neurostimulator according to claim 1, wherein application of the electrical signal to the vagus nerve further induces heart rate variability during the signal ON time.

6. The vagus nerve neurostimulator according to claim 1, wherein the pulsed electrical signal further comprises a ramp-up time and a ramp-down time;

and

application of the electrical signal to the vagus nerve further induces heart rate variability during the ramp-up time, the signal ON time, and the ramp-down time.

7. The vagus nerve neurostimulator according to claim 1, wherein the leadless heart rate sensor is configured to continually monitor heart rate against a stored baseline heart rate.

8. The vagus nerve neurostimulator according to claim 7, wherein the vagus nerve neurostimulator is further configured to suspend application of the electrical signal to the vagus nerve for a fixed period of time in response to the monitored heart falling below a stored lower bound.

9. The vagus nerve neurostimulator according to claim 7, wherein the vagus nerve neurostimulator is further configured to gradually down titrate the electrical signal in response to the monitored heart rate falling below a stored lower bound.

10. The vagus nerve neurostimulator according to claim 7, wherein the vagus nerve neurostimulator is further configured to gradually up titrate the electrical signal in response to the monitored heart rate rising above a stored upper bound.

11. A vagus nerve neurostimulator for modulating autonomic cardiovascular drive, comprising:

a pulse generator, wherein the pulse generator generates a pulsed electrical signal comprising;

a signal ramp-up time;

a signal ramp-down time;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency of approximately 10 Hz;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

a therapy lead;

an electrode communicatively coupled to the pulse generator via the therapy lead, wherein the electrical signal is applied to a vagus nerve via the electrode to propagate action potentials in both afferent and efferent directions along the vagus nerve at an intensity that avoids acute physiological side effects; and

a leadless heart rate sensor.

12. The vagus nerve neurostimulator according to claim 11, wherein application of the electrical signal to the vagus nerve further induces heart rate variability during the ramp-up time, the signal ON time, and the ramp-down time.

13. The vagus nerve neurostimulator according to claim 11, wherein the signal ramp-up time is two seconds.

14. The vagus nerve neurostimulator according to claim 11, wherein the signal ramp-down time is two seconds.

15. The vagus nerve neurostimulator according to claim 11, wherein the output current, the signal frequency or the pulse width of the pulsed electrical signal is modified during the ramp-up time.

16. The vagus nerve neurostimulator according to claim 11, wherein the output current, the signal frequency or the pulse width of the pulsed electrical signal is modified during the ramp-down time.

17. A vagus nerve neurostimulator for modulating autonomic cardiovascular drive, comprising:

a pulse generator, wherein the pulse generator generates a pulsed electrical signal comprising;

a signal ON time;

a signal OFF time;

an output current;

a signal frequency of approximately 10 Hz;

a pulse width; and

a duty cycle defined by dividing the signal ON time by the sum of the signal ON time and signal OFF time;

a therapy lead;

an electrode communicatively coupled to the pulse generator via the therapy lead, wherein the electrical signal is applied to a vagus nerve via the electrode to;

propagate action potentials in both afferent and efferent directions along the vagus nerve; and

induce heart rate variability during the signal ON time at an intensity that avoids acute physiological side effects; and

a leadless heart rate sensor.

18. The vagus nerve neurostimulator according to claim 17, wherein the pulsed electrical signal further comprises a signal ramp-up time.

19. The vagus nerve neurostimulator according to claim 17, wherein the pulsed electrical signal further comprises a signal ramp-down time.

20. The vagus nerve neurostimulator according to claim 17, wherein the duty cycle comprises a value in a range of 5% to 20%.