Active implantable medical device with automatic optimization of the configuration of a multi-electrode stimulation lead

• US 9,855,428 B2
• Filed: 07/29/2016
• Issued: 01/02/2018
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Inria Institut National de Recherche EN Informatique et EN Automatique, Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Inria Institut National de Recherche EN Informatique et EN Automatique, Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: Henry, Christine, Laporte-Duchemin, Laure, Andreu, David, Azevedo-Coste, Christine, Guiraud, David, Maciejasz, Pawel, Rossel, Olivier
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US15/224,328
• Publication Number:
  US 20160331975A1
• Time in Patent Office: 522 Days
• 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. 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.

2. The method of claim 1, 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.

3. The method of claim 2, 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.

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

5. The method of claim 1, 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.

6. The method of claim 1, 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.

7. The method of claim 1, 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.