Vagus nerve and carotid baroreceptor stimulation system

• US 9,737,716 B2
• Filed: 08/12/2014
• Issued: 08/22/2017
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Libbus, Imad, KenKnight, Bruce H., Amurthur, Badri
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/457,754
• Publication Number:
  US 20160045741A1
• Time in Patent Office: 1,106 Days
• Field of Search: 607 44
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters

Abstract

Systems and methods are provided for delivering vagus nerve stimulation and carotid baroreceptor stimulation to patients for treating chronic heart failure and hypertension. The vagus nerve stimulation and carotid baroreceptor stimulation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies.

Claims

1. An implantable neurostimulation system, comprising:

a first VNS electrode assembly configured to couple to and deliver electrical stimulation to a vagus nerve; and

a first CBS electrode assembly configured to couple to and deliver electrical stimulation to carotid baroreceptors; and

a pulse generator comprising;

a vagus nerve stimulation (VNS) subsystem comprising VNS stimulation circuitry;

an implantable carotid baroreceptor stimulation (CBS) subsystem comprising CBS stimulation circuitry; and

a control system that;

activates the VNS subsystem and controls the VNS stimulation circuitry to deliver electrical energy to the first VNS electrode assembly according to a first set of parameters; and

activates the CBS subsystem and controls the CBS stimulation circuitry to deliver electrical energy to the first CBS electrode assembly according to a second set of parameters different than the first set of parameters.

2. The system according to claim 1, further comprising:

a first lead assembly coupled to the pulse generation module, said first lead assembly comprising the first VNS electrode assembly and the first CBS electrode assembly.

3. The system according to claim 2, wherein:

the first lead assembly comprises a bifurcated portion coupled to a first VNS lead portion and a first CBS lead portion, wherein the first VNS electrode assembly is provided at a distal end of the first VNS lead portion and the first CBS electrode assembly is provided at a distal end of the first CBS lead portion.

4. The system according to claim 2, wherein:

the first lead assembly comprises a cuff portion configured to wrap around both the vagus nerve and a carotid artery, said first VNS electrode assembly and the first CBS electrode assembly being provided on the cuff portion.

5. The system according to claim 1, further comprising:

a first lead assembly coupled to the pulse generation module, wherein said the first VNS electrode assembly is provided at a distal end of the first lead assembly; and

a second lead assembly coupled to the pulse generation module, wherein said the first CBS electrode assembly is provided at a distal end of the second lead assembly.

6. The system according to claim 1, further comprising:

a first lead assembly coupled to the pulse generation module, wherein said the first VNS electrode assembly is provided at a distal end of the first lead assembly;

a second CBS electrode assembly configured to couple to and deliver electrical stimulation to carotid baroreceptors; and

a second lead assembly coupled to the pulse generation module, said second lead assembly comprising a bifurcated portion coupled to a first CBS lead portion and a second CBS lead portion, wherein the first CBS electrode assembly is provided at a distal end of the first CBS lead portion and the second CBS electrode assembly is provided at a distal end of the second CBS lead portion.

7. The system according to claim 1, further comprising:

a second VNS electrode assembly configured to couple to and deliver electrical stimulation to a vagus nerve;

a second CBS electrode assembly configured to couple to and deliver electrical stimulation to carotid baroreceptors;

a first lead assembly coupled to the pulse generation module, said first lead assembly comprising a first bifurcated portion coupled to a first VNS lead portion and a first CBS lead portion, wherein the first VNS electrode assembly is provided at a distal end of the first VNS lead portion and the first CBS electrode assembly is provided at a distal end of the first CBS lead portion; and

a second lead assembly coupled to the pulse generation module, said second lead assembly comprising a second bifurcated portion coupled to a second VNS lead portion and a second CBS lead portion, wherein the second VNS electrode assembly is provided at a distal end of the second VNS lead portion and the second CBS electrode assembly is provided at a distal end of the second CBS lead portion.

8. The system according to claim 1, further comprising:

a heart rate sensing module coupled to the control system.

9. The system according to claim 8, wherein:

the heart rate sensing module is configured to detect electrocardiographic (ECG) signals between an electrically active portion of a housing of the pulse generation module and one or more of the first VNS electrode assembly and first CBS electrode assembly.

10. The system according to claim 1, wherein:

the control system is configured to modify a stimulation parameter of the CBS subsystem in response to detected state changes.

11. The system according to claim 10, wherein:

the control system is configured to modify the stimulation parameter of the CBS subsystem during predetermined periods of time.

12. The system according to claim 10, wherein:

the control system is configured to modify the stimulation parameter of the CBS subsystem in response to detected physiological changes.

13. The system according to claim 12, wherein:

the control system is configured to modify the stimulation parameter of the CBS subsystem in response to detected changes in heart rate.

14. The system according to claim 12, wherein:

the control system is configured to increase the stimulation parameter of the CBS subsystem and increase a stimulation parameter of the VNS subsystem in response to detected physiological changes.

15. The system according to claim 14, wherein:

the control system is configured to alternately increase the stimulation parameter of the CBS subsystem and the stimulation parameter of the VNS subsystem in response to detected physiological changes.

16. The system according to claim 14, wherein:

the control system is configured to simultaneously increase the stimulation parameter of the CBS subsystem and the stimulation parameter of the VNS subsystem in response to detected physiological changes.

17. The system according to claim 1, wherein:

the control system is configured to activate the VNS subsystem to deliver electrical stimulation with a first stimulation parameter and to activate the CBS subsystem to deliver electrical stimulation with a second stimulation parameter different than the first stimulation parameter, wherein the first and second stimulation parameters correspond to one or more of the following;

stimulation amplitude, stimulation frequency, stimulation pulse width, or stimulation duty cycle.

18. The system according to claim 1, wherein the second set of parameters comprises an amplitude between 0.5 mA to 7.0 mA and a stimulation frequency between 20 Hz and 100 Hz.