Vagus nerve stimulation and subcutaneous defibrillation system

• US 9,770,599 B2
• Filed: 08/12/2014
• Issued: 09/26/2017
• 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, Stubbs, Scott R.
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/457,843
• Publication Number:
  US 20160045754A1
• Time in Patent Office: 1,141 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• 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 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Systems and methods are provided for delivering vagus nerve stimulation and cardioversion/defibrillation therapies to patients for treating chronic heart failure. The vagus nerve stimulation and cardioversion/defibrillation therapies may be provided using a single implantable pulse generator, which can coordinate delivery of the therapies to provide an acute vagus nerve stimulation therapy in advance of delivering cardioversion-defibrillation energy.

Claims

1. A method of operating an implantable neurostimulation system, comprising:

delivering a chronic vagus nerve stimulation (VNS) therapy to a vagus nerve with a VNS subsystem of a pulse generation module via a VNS electrode provided on a single lead body;

in response to detection of a cardiac event, delivering electrical cardioversion-defibrillation energy with an implantable cardioverter-defibrillator (ICD) subsystem of the pulse generation module via a first vector between a conductive electrode of a housing containing the ICD subsystem in an anterior position of a thorax and a first subcutaneous electrode provided on the single lead body and positioned along an axillary axis of the thorax; and

delivering electrical cardioversion-defibrillation energy with the ICD subsystem via a second vector between the first subcutaneous electrode and a second subcutaneous electrode provided on the single lead body and positioned along a medial axis of the thorax.

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

in response to detection of the cardiac event, delivering an acute VNS therapy with the VNS subsystem of the pulse generation module.

3. The method according to claim 2, wherein delivering the acute VNS therapy comprises applying a higher intensity electrical stimulation than the chronic VNS therapy.

4. The method according to claim 1, wherein:

the delivering electrical cardioversion-defibrillation energy with the ICD subsystem via the first vector comprises delivering electrical cardioversion-defibrillation energy with the ICD subsystem via the first vector between the conductive electrode of the housing positioned in a first anterior location of a thorax and the first subcutaneous electrode positioned in a posterior location of the thorax; and

the delivering electrical cardioversion-defibrillation energy with the ICD subsystem via the second vector comprises delivering electrical cardioversion-defibrillation energy with the ICD subsystem via the second vector between the first subcutaneous electrode and the second subcutaneous electrode positioned in a second anterior location of the thorax.

5. The method according to claim 1, wherein the delivering the chronic VNS therapy to the vagus nerve comprises delivering the chronic VNS therapy to the vagus nerve with a VNS electrode coupled to the vagus nerve between the clavicle and the mastoid process.

6. The method according to claim 1, wherein the cardiac event detected is an arrhythmia suitable for treatment with defibrillation.

7. The method according to claim 1, wherein:

the VNS electrode is provided at an end of the single lead body distal from the pulse generation module; and

the first subcutaneous electrode is provided at an intermediate location on the single lead body between the pulse generation module and the VNS electrode.

8. The method according to claim 7, wherein the second subcutaneous electrode is provided at a second intermediate location on the single lead body between the pulse generation module and the VNS electrode.

9. The method according to claim 1, further comprising detecting a cardiac event via a sensing electrode.

10. The method according to claim 9, wherein detecting the cardiac event via the sensing electrode comprises detecting the cardiac event via the sensing electrode provided at an intermediate location on a lead body between the pulse generation module and the first subcutaneous electrode.