Vagus nerve and carotid baroreceptor stimulation system

Patent metadata

Field	Value
Publication number	US-11918812-B2
Application number	US-202016854054-A
Country	US
Kind code	B2
Filing date	Apr 21, 2020
Priority date	Aug 12, 2014
Publication date	Mar 5, 2024
Grant date	Mar 5, 2024

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.

First claim

What is claimed is:

1. A method of operating an implantable neurostimulation system, comprising:
delivering a carotid baroreceptor stimulation (CBS) therapy to carotid baroreceptors of a patient for a treatment of chronic heart failure, according to a set of parameters, with a pulse generator via a CBS electrode assembly having at least one CBS electrode contact and an integrated pressure sensor configured to sense a blood pressure of the patient, the at least one CBS electrode contact and the integrated pressure sensor integrated into a single cuff structure;
determining an activity level of the patient based on the sensed blood pressure of the patient; and
modifying the set of parameters of the CBS therapy based on the determined activity level, wherein, in a first activity level state, the CBS therapy is delivered at a first intensity and, in a second activity level state, the CBS therapy is delivered at a second intensity different than the first intensity.

2. The method according to claim 1 , further comprising:
detecting subcutaneous electrocardiographic (ECG) signals; and
determining, based on the ECG signals, a change in a heart rate in response to the CBS therapy.

3. The method according to claim 1 , wherein:
determining the activity level of the patient comprises estimating when the patient is in a sleep state based on the sensed blood pressure of the patient; and
the set of parameters of the CBS therapy are modified from the first intensity to the second intensity when the patient is estimated to be in the sleep state.

4. The method according to claim 1 , wherein the CBS electrode assembly is electrically coupled to the carotid baroreceptors.

5. The method according to claim 4 , wherein the single cuff structure is configured to wrap around a carotid artery.

6. The method according to claim 1 , wherein the CBS electrode assembly is a first CBS electrode assembly, and wherein:
delivering the CBS therapy comprises delivering electrical stimulation via the first CBS electrode assembly electrically coupled to a first carotid baroreceptor region and delivering electrical stimulation via a second CBS electrode assembly electrically coupled to a second baroreceptor region.

7. The method according to claim 1 , wherein the CBS electrode assembly is a first CBS electrode assembly and delivering the CBS therapy comprises:
delivering electrical stimulation via the first CBS electrode assembly electrically coupled to a first carotid baroreceptor region and provided at a distal end of a first CBS lead portion; and
delivering electrical stimulation via a second CBS electrode assembly electrically coupled to a second carotid baroreceptor region and provided at a distal end of a second CBS lead portion, the first CBS lead portion and the second CBS lead portion coupled to a bifurcated portion of a lead assembly.

8. The method according to claim 1 , wherein the CBS electrode assembly is a first CBS electrode assembly and delivering the CBS therapy comprises:
delivering electrical stimulation via the first CBS electrode assembly electrically coupled to a first carotid baroreceptor region and provided at a distal end of a first CBS lead portion, the first CBS lead portion coupled to a bifurcated portion of a first lead assembly; and
delivering electrical stimulation via a second CBS electrode assembly electrically coupled to a second carotid baroreceptor region and provided at a distal end of a second CBS lead portion, the second CBS lead portion coupled to a bifurcated portion of a second lead assembly.

9. The method according to claim 1 , further comprising:
delivering a vagus nerve stimulation (VNS) therapy to a vagus nerve of the patient for the treatment of chronic heart failure, according to a second set of parameters, with the pulse generator.

10. The method according to claim 9 , wherein at least a portion of the CBS therapy is provided during a same time during which at least a portion of the VNS therapy is provided.

11. A non-transitory computer-readable medium having instructions stored thereon that are executable by a processor of an implantable neurostimulation system to cause the processor to perform operations comprising:
delivering a carotid baroreceptor stimulation (CBS) therapy to carotid baroreceptors of a patient, according to a set of parameters, with a pulse generator via a CBS electrode assembly having at least one CBS electrode contact and an integrated pressure sensor configured to sense a blood pressure of the patient, the at least one CBS electrode contact and the integrated pressure sensor integrated into a single cuff structure;
determining an activity level of the patient based on the sensed blood pressure of the patient; and
modifying the set of parameters of the CBS therapy based on the determined activity level, wherein, in a first activity level state, the CBS therapy is delivered at a first intensity and, in a second activity level state, the CBS therapy is delivered at a second intensity different than the first intensity.

12. The non-transitory computer-readable medium of claim 11 , wherein the operations further comprise:
detecting subcutaneous electrocardiographic (ECG) signals; and
determining, based on the ECG signals, a change in a heart rate in response to the CBS therapy.

13. The non-transitory computer-readable medium of claim 11 , wherein:
determining the activity level of the patient comprises estimating when the patient is in a sleep state based on the sensed blood pressure of the patient; and
the set of parameters of the CBS therapy are modified from the first intensity to the second intensity when the patient is estimated to be in the sleep state.

14. The non-transitory computer-readable medium of claim 11 , wherein delivering the CBS therapy comprises delivering bilateral CBS therapy to a first baroreceptor region and a second baroreceptor region.

15. The non-transitory computer-readable medium of claim 11 , wherein the CBS electrode assembly is electrically coupled to the carotid baroreceptors.

16. The non-transitory computer-readable medium of claim 15 , wherein the single cuff structure is configured to wrap around a carotid artery.

17. The non-transitory computer-readable medium of claim 11 , wherein the CBS electrode assembly is a first CBS electrode assembly and delivering the CBS therapy comprises delivering electrical stimulation via the first CBS electrode assembly electrically coupled to a first carotid baroreceptor region and delivering electrical stimulation via a second CBS electrode assembly electrically coupled to a second baroreceptor region.

18. The non-transitory computer-readable medium of claim 11 , wherein the operations further comprise:
delivering a vagus nerve stimulation (VNS) therapy to a vagus nerve of the patient, according to a second set of parameters, with the pulse generator.

19. The non-transitory computer-readable medium of claim 18 , wherein at least a portion of the CBS therapy is provided during a same time during which at least a portion of the VNS therapy is provided.

Assignees

• Livanova Usa Inc

Inventors

• Libbus Imad
• Kenknight Bruce H
• Amurthur Badri

Classifications

• A61N1/36146 Primary

  specified by the stimulation parameters · CPC title

• A61N1/36057

  adapted for stimulating afferent nerves · CPC title

• A61N1/36114 Primary

  Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362) · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title