System for stimulation therapy of the vagus nerve by implementation of a state transition model with a learning phase

Patent metadata

Field	Value
Publication number	US-9981132-B2
Application number	US-201615195767-A
Country	US
Kind code	B2
Filing date	Jun 28, 2016
Priority date	Jun 29, 2015
Publication date	May 29, 2018
Grant date	May 29, 2018

Abstract

One system includes a stimulation device such as a vagus nerve stimulation lead, and a controller for controlling the stimulation device according to a set of stimulation parameters. A memory of the stimulation device contains a state transition model, and for each state defines a set of stimulation parameters and at least one expected response during the application of stimulation with the parameters. A matrix determines the transition rules between states based on physiological levels measured versus target levels. A state transition control unit determines, in an organized timely method, possible transitions between states according to the rules on physiological levels obtained in response to the implementation of the stimulation parameters of the current state, and a transition from a current state to a new state causes a corresponding change in the parameter set used for stimulation.

First claim

What is claimed is:

1. A pacing therapy system, comprising:
an external communication device;
a stimulation device adapted to communicate with the external communication device, the stimulation device comprising:
one or more electrodes adapted to be placed on or near a nerve of an autonomic nervous system;
a sensor that senses at least one of a physiological signal or a physical signal;
a processing circuit that provides at least one of a current physiological level or a current physical level using the sensor; and
a control circuit that causes the stimulation device to provide a stimulation according to a set of stimulation parameters;
wherein the control circuit comprises a memory having a state transition model comprising a transition matrix and a connection matrix stored thereon, the transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and the connection matrix defining whether transitions between particular pairs of states are permitted, wherein the plurality of states are defined by a set of stimulation parameters and at least one of an expected physiological response or an expected physical response during application of the stimulation with the sets of stimulation parameters;
wherein the control circuit is initialized from a learning phase whereby at least one of an actual physiological level or an actual physical level is determined and stored for a predetermined set of stimulation parameters used during the learning phase, and
wherein the control circuit is configured to:
for each set of stimulation parameters, raise a value of at least one of the actual physiological level or the actual physical level;
order the plurality of states according to the at least one of the actual physiological level or the actual physical level;
depending on the result of the ordering the plurality of states, assign to the set of stimulation parameters of each state a second set of stimulation parameters; and
determine a plurality of stimulation instructions defined by transitions between sets of stimulation parameters in accordance with a target value for the at least one of the actual physiological level or the actual physical level.

2. The system of claim 1 , wherein the learning phase is based on a patient population.

3. The system of claim 1 , wherein the learning phase is individually adapted to each patient receiving the pacing therapy system, according to specific characteristics.

4. The system of claim 1 , wherein the learning phase is initially based on a patient population and individually adapted for each patient receiving the pacing therapy system.

5. The system of claim 1 , wherein the state transition matrix, the connection matrix, the sets of stimulation parameters and the at least one of the expected physiological response or the expected physical response of the state transition model are determined from the learning phase.

6. The system of claim 5 , wherein the plurality of states of the state transition model and the associated sets of stimulation parameters are determined from an ascending sort of the at least one of the actual physiological level or the actual physical level determined during the learning phase.

7. The system of claim 6 , wherein the sorting of the state transition model is based on several physiological and/or physical variables.

8. The system of claim 5 , the connection matrix being determined from adverse effects information collected by the learning phase.

9. The system of claim 5 , wherein a sequence of sets of stimulation parameters is applied according to a predetermined method.

10. The system of claim 5 , wherein a sequence of sets of stimulation parameters is applied randomly.

11. A method of applying a pacing therapy to a nerve of an autonomic nervous system with a stimulation device, comprising:
regulating the stimulation device using a state transition model comprising a transition matrix and a connection matrix, the transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and the connection matrix defining whether transitions between particular pairs of states are permitted, wherein the plurality of states of the state transition model are defined by a set of stimulation parameters values and at least one of an expected physiological or an expected physical response during application of a stimulation with the sets of stimulation parameters;
applying to a patient a series of stimuli with the sets of stimulation parameters;
for each set of stimulation parameters, raising a value of at least one of an actual physiological level or an actual physical level;
ordering the plurality of states according to the at least one of the actual physiological level or the actual physical level;
depending on the result of ordering the plurality of states, assigning to the set of stimulation parameters of each state a second set of stimulation parameters; and
determining a plurality of stimulation instructions defined by transitions between sets of stimulation parameters in accordance with a target value for the at least one of the actual physiological level or the actual physical level.

12. The method of claim 11 , wherein applying to the patient the series of stimuli is implemented in a population of patients.

13. The method of claim 11 , wherein applying to the patient the series of stimuli is implemented on a patient receiving the stimulation device.

14. The method of claim 11 , wherein applying to the patient the series of stimuli is implemented on a population of patients, then on a patient receiving the stimulation system.

15. The method of claim 11 , wherein the plurality of stimulation instructions comprises the state transition model and the method further comprises determining transition rules between the plurality of states according to at least one of the actual physiological level or the actual physical level and a target value.

16. The method of claim 11 , further comprising detecting adverse effects for each set of parameters, and determining the connection matrix in response to detecting the adverse effects to prohibit transitions to sets of stimulation parameters that cause the adverse effects.

17. The method of claim 11 , wherein applying the series of stimuli with the plurality of sets of stimulation parameters occurs according to a predetermined method.

18. The method of claim 11 , wherein applying the series of stimuli with the plurality of sets of stimulation parameters occurs randomly.

19. The method of claim 11 , wherein ordering the plurality of states of the state transition model is based on an ascending order of the at least one of the actual physical level or the actual physiological level.

20. A pacing therapy device comprising:
a stimulation device; and
a control circuit that causes the stimulation device to provide a stimulation to a nerve of an autonomic nervous system according to a set of stimulation parameters, the control circuit comprising a memory having a state transition model comprising a transition matrix and a connection matrix stored thereon, the transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and the connection matrix defining whether transitions between particular pairs of states are permitted, wherein the plurality of states are defined by a set of stimulation parameters and at lea

Assignees

• Sorin Crm Sas
• Univ Rennes
• Inserm Institut De La Rech Medicale
• Inserm—Institut De La Rech Medicale

Inventors

• Bonnet Jean-Luc
• Hernandez Alfredo
• Carrault Guy
• Romero Hector
• Le Rolle Virginie

Classifications

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/36053

  adapted for vagal stimulation (A61N1/36114 takes precedence) · CPC title

• A61N1/36125

  Details of circuitry or electric components · CPC title

• G16H50/50

  for simulation or modelling of medical disorders · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title