SYSTEMS AND METHODS FOR AUTONOMIC NERVE MODULATION

• US 20100228310A1
• Filed: 03/02/2010
• Published: 09/09/2010
• Est. Priority Date: 03/09/2009
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhao, Weiying, Ruble, Stephen, Hamann, Jason J., Shuros, Allan C.
• Application Number:
  US12/715,862
• Publication Number:
  US 20100228310A1
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

According to various embodiments of a method for modulating autonomic neural activity in a body having a spinal cord, a subclavian vein and thoracic lymphatic vessels that include a thoracic duct and a right lymphatic duct, at least one programmed therapy is implemented using an implanted medical device to modulate autonomic neural activity. Implementing the therapy includes increasing or decreasing sympathetic activity in sympathetic nerves branching from a first region of the spinal cord using a first electrode in the thoracic duct, and further includes increasing or decreasing parasympathetic activity in parasympathetic nerves adjacent to the desired thoracic lymphatic vessel or sympathetic activity in sympathetic nerves branching from a second region of the spinal cord using a second electrode in the desired thoracic lymphatic vessel.

Claims

1. A system for modulating autonomic neural activity in a body having a spinal cord, a subclavian vein and thoracic lymphatic vessels that include a thoracic duct and a right lymphatic duct, the system comprising:

at least one stimulation lead including at least a first electrode region and a second electrode region, the at least one stimulation lead being adapted to be fed through the subclavian vein into a desired thoracic lymphatic vessel to operationally position the first electrode region in the thoracic lymphatic vessel to stimulate sympathetic nerves branching from a first region of the spinal cord and to operationally position the second electrode region in the desired thoracic lymphatic vessel to stimulate sympathetic nerves branching from a second region of the spinal cord or stimulate parasympathetic nerves anatomically adjacent to the desired thoracic lymphatic vessel; and

a programmable neural stimulator programmed to deliver neural stimulation pulses to the first electrode region to modulate sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord and to deliver neural stimulation pulses to the second electrode region to modulate sympathetic activity in the sympathetic nerves branching from the second region of the spinal cord or to modulate parasympathetic activity in the parasympathetic nerves anatomically adjacent to the desired thoracic lymphatic vessel.

2. The system of claim 1, wherein the at least one stimulation lead includes a third electrode region, and the at least one stimulation lead is adapted to be fed into the desired thoracic lymphatic vessel to operationally position the second electrode region in the thoracic lymphatic vessel to stimulate the sympathetic nerves branching from the second region of the spinal cord, and to operationally position the third electrode region in the thoracic lymphatic vessel to stimulate parasympathetic nerves anatomically adjacent to the thoracic lymphatic vessel.

3. The system of claim 1, wherein the sympathetic nerves includes sympathetic nerves branching from the C5-T5 region of the spinal cord.

4. The system of claim 1, wherein the parasympathetic nerves includes a vagus nerve positioned anatomically adjacent to the desired thoracic lymphatic vessel.

5. The system of claim 1, wherein the programmable neural stimulator is programmed to deliver neural stimulation pulses to the first electrode region to decrease sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord and to deliver neural stimulation pulses to the first electrode region to increase sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord.

6. The system of claim 1, wherein the programmable neural stimulator is programmed to deliver neural stimulation pulses to the second electrode region to decrease parasympathetic activity in the parasympathetic nerves and to deliver neural stimulation pulses to the second electrode region to increase parasympathetic activity in the parasympathetic nerves.

7. The system of claim 1, wherein the at least one stimulation lead is a single lead that includes the first and second electrode regions.

8. The system of claim 7, wherein the single lead is a telescoping lead adapted to adjust the distance between the first electrode region and the second electrode region in the lead.

9. The system of claim 1, wherein the programmable neural stimulator is programmed to:

chronically deliver neural stimulation pulses to the first electrode region to chronically inhibit sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord; and

intermittently deliver neural stimulation pulses to the second electrode region to intermittently increase parasympathetic activity in the parasympathetic nerves.

10. The system of claim 1, wherein the programmable neural stimulator is programmed to:

chronically deliver neural stimulation pulses to the first electrode region to increase sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord; and

intermittently or chronically deliver neural stimulation pulses to the second electrode region to increase parasympathetic activity in the parasympathetic nerves.

11. The system of claim 1, further comprising a respiratory sensor operationally connected to the neural stimulator and adapted for use to detect an inspiratory and expiratory phase of a respiration cycle, wherein the programmable neural stimulator is programmed to:

time delivery of neural stimulation pulses to the first electrode region to decrease sympathetic activity during the inspiratory phase; and

time delivery of neural stimulation pulses to the second electrode region to increase parasympathetic activity during the expiratory phase.

12. The system of claim 1, further comprising a respiratory sensor operationally connected to the neural stimulator and adapted for use to detect an inspiratory and expiratory phase of a respiration cycle, wherein the programmable neural stimulator is programmed to:

time delivery of neural stimulation pulses to the first electrode region to decrease sympathetic activity during the inspiratory phase; and

time delivery of neural stimulation pulses to the second electrode region to increase parasympathetic activity during the inspiratory phase.

13. The system of claim 1, further comprising a respiratory sensor operationally connected to the neural stimulator and adapted for use to detect an inspiratory and expiratory phase of a respiration cycle, wherein the programmable neural stimulator is programmed to:

deliver neural stimulation pulses to the first electrode region to chronically decrease sympathetic activity; and

time delivery of neural stimulation pulses to the second electrode region to the respiratory cycle to intermittently increase parasympathetic activity.

14. The system of claim 1, further comprising a respiratory sensor operationally connected to the neural stimulator and adapted for use to detect an inspiratory and expiratory phase of a respiration cycle, wherein the programmable neural stimulator is programmed to:

deliver neural stimulation pulses to the second electrode region to chronically increase parasympathetic activity; and

time delivery of neural stimulation pulses to the first electrode region to the respiratory cycle to intermittently decrease sympathetic activity.

15. The system of claim 1, further comprising an arrhythmia detector adapted for use in detecting a cardiac arrhythmia, wherein the programmable neural stimulator is programmed to:

implement an anti-arrhythmia therapy by delivering neural stimulation pulses to the first electrode region to decrease sympathetic activity in the sympathetic nerves if the arrhythmia detector detects the cardiac arrhythmia; and

implement a chronic heart failure therapy by delivering neural stimulation pulses to the second electrode region to chronically increase parasympathetic activity in the parasympathetic nerves.

16. The system of claim 1, wherein the programmable neural stimulator is programmed to:

deliver neural stimulation pulses to the first electrode region to increase sympathetic activity in the sympathetic nerves;

deliver neural stimulation pulses to the second electrode region to increase parasympathetic activity in the parasympathetic nerves; and

control timing of the neural stimulation pulses to intermittently increase both sympathetic and parasympathetic activity, and to follow increased sympathetic activity with increased parasympathetic activity.

17. The system of claim 1, wherein:

the first electrode region has a plurality of electrodes and the second electrode region has a plurality of electrodes; and

the programmable neural stimulator is programmed to implement a neural stimulation test routine to assess neural stimulation efficacy for electrode subsets in the first and second electrode regions to identify a desired electrode subset to elicit desired responses.

18. The system of claim 17, wherein the programmable neural stimulator is programmed to:

implement the neural stimulation test routine to assess neural stimulation efficacy for at least two stimulation vectors available for the desired electrode subset;

or

assess neural stimulation efficacy for at least two neural stimulation intensity levels for the desired electrode subset.

19. A method for modulating autonomic neural activity in a body having a spinal cord, a subclavian vein and thoracic lymphatic vessels that include a thoracic duct and a right lymphatic duct, the method comprising:

implementing at least one programmed therapy using an implanted medical device to modulate autonomic neural activity, wherein implementing at least one programmed therapy includes;

increasing or decreasing sympathetic activity in sympathetic nerves branching from a first region of the spinal cord using a first electrode in a desired thoracic lymphatic vessel; and

increasing or decreasing parasympathetic activity in parasympathetic nerves adjacent to the desired thoracic lymphatic vessel or sympathetic activity in sympathetic nerves branching from a second region of the spinal cord using a second electrode in the desired thoracic lymphatic vessel.

20. The method of claim 19, wherein implementing at least one programmed therapy includes:

increasing or decreasing sympathetic activity in sympathetic nerves branching from a C5-T5 region of the spinal cord using the first electrode; and

increasing or decreasing parasympathetic activity in a vagus nerve using the second electrode in the thoracic duct.

21. The method of claim 19, wherein implementing at least one programmed therapy includes:

chronically delivering neural stimulation pulses to the first electrode to chronically inhibit sympathetic activity in the sympathetic nerves; and

intermittently delivering neural stimulation pulses to the second electrode to intermittently increase parasympathetic activity in the parasympathetic nerves.

22. The method of claim 19, wherein implementing at least one programmed therapy includes:

chronically delivering neural stimulation pulses to the first electrode to increase sympathetic activity in the sympathetic nerves; and

intermittently delivering neural stimulation pulses to the second electrode to intermittently increase parasympathetic activity in the parasympathetic nerves.

23. The method of claim 19, wherein implementing at least one programmed therapy includes:

chronically delivering neural stimulation pulses to the first electrode to increase sympathetic activity in the sympathetic nerves branching from the first region of the spinal cord; and

intermittently or chronically delivering neural stimulation pulses to the second electrode to increase parasympathetic activity in the parasympathetic nerves.

24. The method of claim 19, wherein implementing at least one programmed therapy includes:

detecting an inspiratory and expiratory phase of a respiration cycle;

timing delivery of neural stimulation pulses to the first electrode to decrease sympathetic activity during the inspiratory phase in the sympathetic nerves branching from the first region of the spinal cord; and

timing delivery of neural stimulation pulses to the second electrode to increase parasympathetic activity during the expiratory phase in the parasympathetic nerves.

25. The method of claim 19, wherein implementing at least one programmed therapy includes:

detecting a cardiac arrhythmia;

implementing an anti-arrhythmia therapy, wherein implementing the anti-arrhythmia therapy includes delivering neural stimulation pulses to the first electrode to decrease sympathetic activity in the sympathetic nerves if the arrhythmia detector detects the cardiac arrhythmia; and

implementing a chronic heart failure therapy, wherein implementing the chronic heart failure therapy includes delivering neural stimulation pulses to the second electrode to chronically increase parasympathetic activity in the parasympathetic nerves.

26. The method of claim 19, wherein implementing at least one programmed therapy includes:

delivering neural stimulation pulses to the first electrode to increase sympathetic activity in the sympathetic nerves;

delivering neural stimulation pulses to the second electrode to increase parasympathetic activity in the parasympathetic nerves; and

timing the neural stimulation pulses to intermittently increase both sympathetic and parasympathetic activity, and to follow increased sympathetic activity with increased parasympathetic activity.

27. A method for implanting a system for modulating both parasympathetic and sympathetic activity in a body having a spinal cord, a subclavian vein and thoracic lymphatic vessels that include a thoracic duct and a right lymphatic duct, the method comprising:

feeding at least one stimulation lead through the subclavian vein into the thoracic lymphatic vessels to operationally position a first electrode region in a desired thoracic lymphatic vessel to stimulate sympathetic nerves branching from a first region of the spinal cord and to operationally position a second electrode region in the thoracic duct to stimulate parasympathetic nerves adjacent to the desired thoracic lymphatic vessel;

implanting a programmable neural stimulator;

operationally attaching the programmable neural stimulator to the at least one stimulation lead to stimulate the sympathetic nerves and parasympathetic nerves; and

implementing a test routine to verify capture of the sympathetic nerves and parasympathetic nerves.

28. The method of claim 27, further comprising programming the programmable neural stimulator to generate stimulation pulses to increase or decrease sympathetic activity in the sympathetic nerves and to generate stimulation pulses to increase or decrease parasympathetic activity in the parasympathetic nerves.