Device and method for selective nerve stimulation

• US 9,895,542 B2
• Filed: 04/05/2016
• Issued: 02/20/2018
• Est. Priority Date: 04/22/2015
• Status: Active Grant

• Current Assignee: Biotronik SE & Company KG
• Original Assignee: Biotronik SE & Company KG
• Inventors: Baru, Marcelo, Kibler, Andrew B.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US15/090,690
• Publication Number:
  US 20160310741A1
• Time in Patent Office: 686 Days
• Field of Search: 607 70, 607 72, 607 74
• 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 1/36185 Selection of the electrode configuration

Abstract

An implantable pulse generator (106) provides electric stimulation pulses for nerve stimulation via a stimulation lead (100) having stimulation electrodes (102, 104). The electric stimulation pulses form a pulse train including (i) an initial selective-arrest phase for the large-diameter fibers in the vicinity of selected electrodes; (ii) followed by a charge-balanced phase where a charge-balanced alternating current (AC) is applied between the same or other selected electrodes; and (iii) a therapy phase where the charge-balanced alternating current (AC) is briefly unbalanced to deliver nerve stimulation therapy pulses, with the pulse train returning to the charge-balanced phase in between therapy pulses.

Claims

1. An implantable pulse generator (106) connected or connectable to a stimulation lead (100) having stimulation electrodes (102, 104) for delivery of stimulation pulses, the implantable pulse generator (106) including:

a. a stimulation unit (36, 38, 40, 42, 44, 46, 48) configured to generate electric stimulation pulses for nerve stimulation,

b. a control unit (50) configured to trigger delivery of generated electric stimulation pulses via selected stimulation electrodes (102, 104), wherein the electric stimulation pulses form a pulse train including;

i) an initial selective-arrest phase configured to arrest action potentials of large-diameter nerve fibers in the vicinity of the selected stimulation electrodes, the selective-arrest phase being effected by rectification of alternating current (AC) generated by the stimulation unit (36, 38, 40, 42, 44, 46, 48),

ii) followed by a charge-balanced phase wherein charge-balanced alternating current is applied between the same or other selected stimulation electrodes,

iii) and where such charge-balanced alternating current is briefly unbalanced to deliver a nerve stimulation therapy pulse, with charge-balanced alternating current again being applied following the therapy pulse.

2. The implantable pulse generator (106) of claim 1 wherein the stimulation electrodes (102, 104) include:

a. a ring electrode (104), and

b. a contact (102) defining an electrode with a smaller contact surface than the ring electrode (104).

3. The implantable pulse generator (106) of claim 2 wherein the stimulation electrodes (102, 104) include:

a. a pair of ring electrodes (104.1, 104.2) axially spaced from each other, and

b. at least two contacts (102) situated between the ring electrodes (104.1, 104.2).

4. The implantable pulse generator (106) of claim 3 wherein the control unit (50) is configured to trigger bipolar stimulation between:

a. a pair of the contacts (102), or

b. a contact (102) and at least one of the ring electrodes (104).

5. The implantable pulse generator (106) of claim 1 wherein the stimulation lead (100) includes a nerve cuff (100) having the stimulation electrodes (102, 104) thereon.

6. The implantable pulse generator (106) of claim 1 wherein the control unit (50) is configured to trigger the pulse train such that the pulse train is time duty-cycled.

7. The implantable pulse generator (106) of claim 1 wherein the control unit (50) is further configured to trigger delivery of a pulse train effecting a passive charge-balancing phase, wherein selected stimulation electrodes (102, 104) are short-circuited during the passive charge-balancing phase.

8. The implantable pulse generator (106) of claim 7 wherein the passive charge-balancing phase includes successive stages, with each stage using a different combination of stimulation electrodes (102, 104) than any immediately prior stage.

9. The implantable pulse generator (106) of claim 1 wherein the control unit (50) is configured to terminate nerve stimulation therapy by interrupting the pulse train.

10. The implantable pulse generator (106) of claim 9 wherein the control unit (50) is further configured to trigger delivery of a pulse train effecting a passive charge-balancing phase immediately after termination of nerve stimulation therapy, wherein selected stimulation electrodes (102, 104) are short-circuited during the passive charge-balancing phase.

11. The implantable pulse generator (106) of claim 1 wherein the stimulation unit (36, 38, 40, 42, 44) includes or is connected to a switched amplifier for generating the alternating current (AC).

12. The implantable pulse generator (106) of claim 11 wherein the switched amplifier is a low-Q Class-E amplifier configured to generate alternating current (AC) with a main frequency from hundreds of Hz to tens of kHz.

13. The implantable pulse generator (106) of claim 1 wherein the implantable pulse generator (106) is configured to effect the selective-arrest phase by rectification of the alternating current (AC) with an envelope approximating a quasi-trapezoidal (QT) pulse.

14. The implantable pulse generator (106) of claim 1 wherein the implantable pulse generator (106) is configured to provide pre-depolarization sub-threshold pulses during the selective-arrest phase.

15. The implantable pulse generator of claim 1 wherein:

a. the selective-arrest phase of the pulse train is configured to arrest action potentials of large-diameter laryngeal and/or pharyngeal nerve fibers in the vicinity of the selected stimulation electrodes, and

b. the charge-balanced alternating current of the charge-balanced phase is configured to promote blocking of conduction by large-diameter laryngeal and/or pharyngeal nerve fibers.

16. The implantable pulse generator of claim 1 wherein the nerve stimulation therapy pulse is:

a. unbalanced, and

b. configured to stimulate parasympathetic activity in smaller-diameter cardiac nerve fibers.

17. An implantable pulse generator configured to deliver electric nerve stimulation pulses to selected electrodes within a set of stimulation electrodes, wherein the electric nerve stimulation pulses define a pulse train including:

a. an initial selective-arrest phase including one or more pulses configured to arrest action potentials of large-diameter nerve fibers nearby the stimulation electrodes,

b. a subsequent charge-balanced phase wherein charge-balanced alternating current pulses are applied between the same or other selected stimulation electrodes,

c. wherein;

i) the pulses of the selective-arrest phase are generated by rectifying the charge-balanced alternating current pulses of the charge-balanced phase, and

ii the charge-balanced alternating current pulses are interrupted by a nerve stimulation therapy phase including one or more unbalanced nerve stimulation therapy pulses, with charge-balanced alternating current pulses following the therapy pulses.

18. The implantable pulse generator of claim 17 wherein the pulses of the selective-arrest phase define a quasi-trapezoidal envelope bounded by:

a. an at least substantially square leading edge defined by a sudden current increase, followed by

b. a plateau defined by at least substantially constant current, followed by

c. an at least substantially exponential trailing phase defined by decreasing current, with the rate of decrease diminishing over time.

19. The implantable pulse generator of claim 17 wherein the pulse train of the electric nerve stimulation pulses further include a passive charge-balancing phase wherein at least some of the stimulation electrodes are short-circuited.

20. The implantable pulse generator of claim 17 wherein:

a. the selective-arrest phase is configured to arrest action potentials of large-diameter laryngeal and/or pharyngeal nerve fibers in the vicinity of the selected stimulation electrodes,

b. the charge-balanced phase is configured to promote blocking of conduction by large-diameter laryngeal and/or pharyngeal nerve fibers, and

c. the nerve stimulation therapy phase is configured to stimulate parasympathetic activity in smaller-diameter cardiac nerve fibers.

21. The implantable pulse generator of claim 17 wherein the nerve stimulation therapy pulses are:

a. unbalanced, and

b. configured to stimulate parasympathetic activity in smaller-diameter cardiac nerve fibers.

22. A method of delivering electric nerve stimulation pulses from an implantable pulse generator to selected electrodes within a set of stimulation electrodes, the method including delivering the electric nerve stimulation pulses as a pulse train including:

a. an initial selective-arrest phase including one or more pulses configured to arrest action potentials of large-diameter nerve fibers nearby the stimulation electrodes, the selective-arrest phase being effected by rectification of alternating current (AC) pulses;

b. a subsequent charge-balanced phase wherein charge-balanced alternating current pulses are applied between the same or other selected stimulation electrodes, the alternating current pulses being configured to promote blocking of conduction by the large-diameter nerve fibers,

c. wherein the charge-balanced alternating current pulses are interrupted by a nerve stimulation therapy phase including one or more unbalanced nerve stimulation therapy pulses configured to stimulate parasympathetic activity, with the charge-balanced alternating current pulses again being applied following the nerve stimulation therapy phase.

23. The method of claim 22 wherein:

a. the selective-arrest phase is configured to arrest action potentials of large-diameter laryngeal and/or pharyngeal nerve fibers in the vicinity of the selected stimulation electrodes,

b. the charge-balanced phase is configured to promote blocking of conduction by large-diameter laryngeal and/or pharyngeal nerve fibers, and

c. the nerve stimulation therapy phase is configured to stimulate parasympathetic activity in smaller-diameter cardiac nerve fibers.

24. The method of claim 22 wherein the nerve stimulation therapy pulses are:

a. unbalanced, and

b. configured to stimulate parasympathetic activity in smaller-diameter cardiac nerve fibers.