Implantable neurostimulator-implemented method utilizing multi-modal stimulation parameters

• US 9,999,773 B2
• Filed: 10/22/2014
• Issued: 06/19/2018
• Est. Priority Date: 10/30/2013
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc), East Tennessee State University (University and Community College System Tennessee State)
• Original Assignee: Cyberonics, Inc, East Tennessee State University (University and Community College System Tennessee State)
• Inventors: Libbus, Imad, Amurthur, Badri, KenKnight, Bruce H., Ardell, Jeffrey L., Ordway, Gregory A.
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/521,044
• Publication Number:
  US 20150119956A1
• Time in Patent Office: 1,336 Days
• CPC Class Codes: A61N 1/0556 Cuff 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 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Multi-modal stimulation therapy may be utilized in which two or more stimulation therapies having different stimulation parameters may be delivered to a single patient. This can preferentially stimulate different nerve fiber types and drive different functional responses in the target organs. The stimulation parameters that may vary between the different stimulation therapies include, for example, pulse frequency, pulse width, pulse amplitude, and duty cycle.

Claims

1. A medical device for vagus nerve stimulation, comprising:

an electrode assembly comprising a first pair of electrodes structured to be implanted on or near a vagus nerve and a second pair of electrodes structured to be implanted on or near the vagus nerve, wherein the first pair of electrodes is configured to be implanted closer to a brain of a patient than the second pair of electrodes, and the second pair of electrodes is configured to be implanted closer to a heart of the patient than the first pair of electrodes;

a neurostimulator coupled to the electrode assembly, said neurostimulator adapted to deliver electrical stimulation to a patient; and

a control system coupled to the neurostimulator, said control system being programmed to cause the neurostimulator to deliver, in a predetermined pattern, a first mode of stimulation by the first pair of electrodes and a second mode of stimulation by the second pair of electrodes, wherein the first mode of stimulation is configured to generate an afferent response in the vagus nerve comprising propagation of action potentials to the brain and the second mode of stimulation is configured to generate an efferent response in the vagus nerve comprising propagation of action potentials to the heart;

wherein at least one of the first mode of stimulation or the second mode of stimulation comprises a stimulation frequency inclusively between 5 and 10 Hz; and

wherein the predetermined pattern comprises delivery of the first mode of stimulation during a first time and delivery of the second mode of stimulation during a second time, wherein delivery of the first mode of stimulation is suspended during the second time and delivery of the second mode of stimulation is suspended during the first time.

2. The device according to claim 1, wherein the first mode of stimulation comprises a first set of stimulation parameters and the second mode of stimulation comprises a second set of stimulation parameters, said first and second sets of stimulation parameters defining one or more of:

amplitude, frequency, pulse width, or duty cycle.

3. The device according to claim 1, wherein the control system is programmed to cause the neurostimulator to deliver a stimulation signal comprising an ON time and an OFF time, wherein said ON time comprises a first stimulation period during which the first mode of stimulation is delivered and a second stimulation period during which the second mode of stimulation is delivered.

4. The device according to claim 3, wherein the first stimulation period is equal to the second stimulation period.

5. The device according to claim 3, wherein the first stimulation period is separated from the second stimulation period by a ramp-down period and a ramp-up period.

6. The device according to claim 1, wherein the control system is programmed to cause the neurostimulator to interleave the first and second modes of stimulation.

7. The device according to claim 6, wherein the control system is programmed to cause the neurostimulator to deliver a stimulation signal comprising an ON time and an OFF time, wherein said ON time comprises a plurality of first stimulation periods during which the first mode of stimulation is delivered and a plurality of second stimulation periods during which the second mode of stimulation is delivered, said plurality of first stimulation periods being interleaved with the plurality of second stimulation periods.

8. The device according to claim 7, wherein a ramp-up period is provided at a beginning of the ON time and a ramp-down period is provided at an end of the ON time.

9. The device according to claim 1, wherein the first pair of electrodes comprises a first bipolar electrode adapted to be coupled to the vagus nerve and the second pair of electrodes comprises a second bipolar electrode adapted to be coupled to the vagus nerve.

10. The device according to claim 1, wherein the first pair of electrodes comprises a first cathode electrode and a first anode electrode, wherein the first cathode electrode is oriented towards and positioned closer to the brain when compared to the first anode electrode, and the second pair of electrodes comprises a second cathode electrode and a second anode electrode, wherein the second cathode electrode is oriented towards and positioned closer to the heart when compared to the second anode electrode.

11. A method of operating a medical device for vagus nerve stimulation comprising a control system, a neurostimulator, and an electrode assembly, said electrode assembly comprising a first pair of electrodes and a second pair of electrodes, wherein the first pair of electrodes is configured to be implanted closer to a brain of a patient than the second pair of electrodes, and the second pair of electrodes is configured to be implanted closer to a heart of the patient than the first pair of electrodes, and said neurostimulator being coupled to the control system and the electrode assembly and being adapted to deliver electrical stimulation to the patient, the method comprising:

operating the control system to activate the neurostimulator to deliver, in a predetermined pattern, a first mode of stimulation and a second mode of stimulation, wherein the first mode of stimulation is configured to generate an afferent response in a vagus nerve comprising propagation of action potentials to the brain and the second mode of stimulation is configured to generate an efferent response in the vagus nerve comprising propagation of action potentials to the heart; and

delivering the first mode of stimulation by the first pair of electrodes and the second mode of stimulation by the second pair of electrodes in the predetermined pattern, the predetermined pattern comprising delivery of the first mode of stimulation during a first time and delivery of the second mode of stimulation during a second time, wherein delivery of the first mode of stimulation is suspended during the second time and delivery of the second mode of stimulation is suspended during the first time;

wherein at least one of the first mode of stimulation or the second mode of stimulation comprises a stimulation frequency inclusively between 5 and 10 Hz.

12. The method of claim 11, wherein the first mode of stimulation comprises a first set of stimulation parameters and the second mode of stimulation comprises a second set of stimulation parameters, said first and second sets of stimulation parameters defining one or more of:

amplitude, frequency, pulse width, or duty cycle.

13. The method of claim 11, wherein said operating the control system comprises operating the control system to cause the neurostimulator to deliver a stimulation signal comprising an ON time and an OFF time, wherein said ON time comprises a first stimulation period during which the first mode of stimulation is delivered and a second stimulation period during which the second mode of stimulation is delivered.

14. The method of claim 13, wherein the first stimulation period is equal to the second stimulation period.

15. The method of claim 13, wherein the first stimulation period is separated from the second stimulation period by a ramp-down period and a ramp-up period.

16. The method of claim 11, wherein said operating the control system comprises operating the control system to cause the neurostimulator to interleave the first and second modes of stimulation.

17. The method of claim 16, wherein said operating the control system comprises operating the control system to cause the neurostimulator to deliver a stimulation signal comprising an ON time and an OFF time, wherein said ON time comprises a plurality of first stimulation periods during which the first mode of stimulation is delivered and a plurality of second stimulation periods during which the second mode of stimulation is delivered, said plurality of first stimulation periods being interleaved with the plurality of second stimulation periods.

18. The method of claim 17, wherein a ramp-up period is provided at a beginning of the ON time and a ramp-down period is provided at an end of the ON time.

19. The method of claim 11, wherein the second mode of stimulation comprises a stimulation frequency between and including 5 and 10 Hz, wherein the first mode of stimulation comprises a high frequency and a low amplitude when compared to the second mode of stimulation, and wherein the second mode of stimulation comprises a high amplitude when compared to the first mode of stimulation.

20. The method of claim 19, wherein the first mode of stimulation comprises a frequency of at least 15 Hz and an amplitude in a range between 0.25 mA and 1.5 mA, and wherein the second mode of stimulation comprises an amplitude in a range between 1.5 mA and 3 mA.