ACTIVE IMPLANTABLE MEDICAL DEVICE WITH AUTOMATIC OPTIMIZATION OF THE CONFIGURATION OF A MULTI-ELECTRODE STIMULATION LEAD

• US 20160331975A1
• Filed: 07/29/2016
• Published: 11/17/2016
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Inria Institut National de Recherche EN Informatique et EN Automatique, Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Inria Institut National de Recherche EN Informatique et EN Automatique, Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Andreu, David, Henry, Christine, Laporte-Duchemin, Laure, Azevedo-Coste, Christine, Guiraud, David, Maciejasz, Pawel, Rossel, Olivier
• Granted Patent: US 9,855,428 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A device includes a pulse generator coupled to a neurostimulation lead placed around the nerve and a set of electrodes individually connected to the generator by a splitter circuit controlled to preferentially stimulate certain regions of the nerve relative to other regions. The device performing an iterative search of an optimal configuration operating by selection of a plurality of different stimulation configurations, storing of a cardiac physiological parameter measured for each selected stimulation configuration, and designation as optimal stimulation configuration of the one of said selected different stimulation configurations, depending on at least the stored values of the physiological parameter measured for different electrode configurations.

Claims

1. An active implantable medical device of neurostimulation by controlled simultaneous application of electrical pulses in several points of a body, comprising:

a control device that generates electrical pulses;

a neurostimulation lead adapted to be placed around, near or within the body, and having a plurality of electrodes individually connected to the control device; and

a sensing electrode;

wherein the control device is capable of varying a stimulation configuration to selectively stimulate certain parts of the body with respect to other regions,

said stimulation configuration comprising a selection of at least one of;

one or more active electrodes from among the plurality of electrodes connected to the control device;

an anode or cathode polarity of the active electrodes;

or

a division of respective currents delivered to the active electrodes,

wherein the control device iteratively determines a selected stimulation configuration, wherein the iterative determination comprises;

applying a plurality of different stimulation configurations;

measuring a physiological parameter representative of the patient'"'"'s cardiac activity with the sensing electrode for each stimulation configuration;

storing the measured physiological parameter for each applied stimulation configuration; and

designating, as the selected stimulation configuration, one of said selected different stimulation configurations, depending on the stored values of the physiological parameter measured for the plurality of different electrode configurations.

2. The device of claim 1, wherein the control device detects adverse effects that might be generated by neurostimulation, wherein storing the measured physiological parameter for each applied stimulation configuration comprises storing for each applied stimulation configuration an indicator of a possible occurrence of an adverse effect.

3. The device of claim 1, wherein the selected configuration is also designated according to the stored values of the indicator of the possible occurrence of the adverse effect and a number of active electrodes used as cathodes with each applied stimulation configuration.

4. The device of claim 1, wherein the selected configuration is designated based on a result of a comparison of the stored values of the measured physiological parameter with a predetermined target level.

5. The device of claim 1, wherein the selected configuration is also designated according to the stored values of the physiological parameter measured for different distributions of the respective currents delivered to the electrodes, for a same configuration of electrodes.

6. The device of claim 1, wherein the iterative determination of the selected stimulation configuration further comprises varying at least one parameter of the electrical pulses.

7. The device of claim 6, wherein said parameter of the electrical pulses is at least one of an intensity of a current pulse and a number of pulses of a pulse burst.

8. The device of claim 1, wherein the physiological parameter is one of an electrocardiogram signal, a pressure signal in the left ventricle of the heart, and an endocardial acceleration signal.

9. The device of claim 8, wherein designating, as the selected stimulation configuration, further comprises calculating a percentage of increase in an RR interval descriptive of a heart rate or a percentage of decrease of cardiac contraction.

10. An active implantable medical device for neurostimulation comprising:

a pulse generator coupled to a neurostimulation lead configured to be placed around a nerve;

one or more electrodes on the neurostimulation lead and individually connected to the pulse generator and controlled to selectively stimulate certain regions of the nerve relative to other regions; and

a control circuit configured to perform an iterative search for a selective stimulation configuration by;

applying a plurality of different stimulation configurations;

measuring a cardiac physiological parameter representative of the patient'"'"'s cardiac activity with the one or more electrode for each stimulation configuration;

storing a cardiac physiological parameter measured for each applied stimulation configuration; and

identifying the selective stimulation configuration of the one of said selected different stimulation configurations, depending on at least the stored values of the physiological parameter measured for the different electrode configurations.

11. The device of claim 10, wherein the selective configuration is designated based on a comparison of the stored values of the measured physiological parameter with a predetermined target level.

12. The device of claim 10, wherein the selective stimulation configuration is also designated according to an indicator of possible occurrence of an adverse effect and a number of active electrodes used as cathodes with each selected stimulation configuration.

13. The device of claim 10, wherein the selective stimulation is also designated according to the stored values of the physiological parameter measured for different distributions of the respective currents delivered to the electrodes, for a same configuration of electrodes.

14. The device of claim 10, wherein the iterative search of the selective stimulation configuration further comprises varying at least one parameter of the electrical pulses.

15. The device of claim 10, wherein the physiological parameter is at least one of an electrocardiogram signal, a pressure signal in a left ventricle of a heart, and an endocardial acceleration signal.

16. A method for configuration of an implantable neurostimulation device comprising:

recording one or more physiological parameters using a sensing lead and a sensing electrode of the implantable neurostimulation device;

setting, by a control circuit of the implantable neurostimulation device, a first stimulation configuration with at least one of a first energy, a first pulse amplitude, or a first number of pulses;

determining, by the control circuit, if conditions of stability of a patient'"'"'s condition are met, and if so, delivering the first stimulation to a nerve by a stimulation lead; and

repeating delivery of the first stimulation while testing a plurality of configurations of a set of stimulation electrodes;

wherein testing the plurality of configurations of the set of stimulation electrodes comprises;

storing the measured physiological parameters of each of the plurality of configurations;

changing, by the control circuit, the configuration of the set of stimulation electrodes; and

determining a selected configuration that produces a best calculated effect on the recorded one or more physiological parameters.

17. The method of claim 16, further comprising:

determining, by the control circuit, if the calculated effect on the recorded on or more physiological parameters reaches a preset target value, and if it does not;

modifying at least one of an amplitude or a number of stimulation pulses; and

repeating the modified stimulation while testing the plurality of configurations of the set of stimulation electrodes.

18. The method of claim 17, further comprising:

determining, after trying all possible configurations, that the preset target value cannot be achieved;

stopping the configuration method; and

selecting a default standard configuration for stimulation.

19. The method of claim 16, wherein the first stimulation configuration comprises a stimulation amplitude of 1 mA and one pulse.

20. The method of claim 16, further comprising selecting the selected configuration for stimulation that includes a least number of cathodes and consumes less power, when it is determined that more than one stimulation configuration produces the same calculated effect.

21. The method of claim 16, further comprising maintaining one configuration of the set of stimulation electrodes, and determining an impact of a change in a current distribution between the different electrodes, and selecting the selected configuration for stimulation based on the electrode configuration and the current distribution.

22. The method of claim 16, further comprising detecting, simultaneously with the measurement of the physiological parameter, an occurrence of an adverse effect, and selecting the selected configuration for stimulation based on an electrode configuration and the configuration that produces fewest adverse effects.