System for stimulation therapy of the vagus nerve by implementation of a state transition model operating at multiple temporal or spatial resolutions

Patent metadata

Field	Value
Publication number	US-10099056-B2
Application number	US-201615195786-A
Country	US
Kind code	B2
Filing date	Jun 28, 2016
Priority date	Jun 29, 2015
Publication date	Oct 16, 2018
Grant date	Oct 16, 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 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 physical level using the sensor; and
a control circuit that causes the stimulation device to provide stimulation according to a set of stimulation parameters, wherein the control circuit uses a state transition model to modify the at least one of the current physical level or the current physiological level and comprises:
a memory having the state transition model stored thereon, comprising a transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and a connection matrix defining whether transitions between pairs of states are permitted, wherein the control circuit has multiresolution capability such that the control circuit can operate at different temporal and/or spatial resolutions to estimate a set of pacing parameters to bring the at least one of the current physiological level or the current physical level to a reference level, wherein the plurality of states of the state transition model are defined by a set of stimulation parameters and at least one of an expected physiological response or an expected physical response during stimulation with the set of stimulation parameters;
a state transition controller that determines transitions from a current state to a new state, causing a corresponding change in the set of stimulation parameters; and
a parameter fusion circuit that defines a final set of stimulation parameters based on parameters estimated by each of the resolutions of the control circuit.

2. The system of claim 1 , wherein each resolution of the control circuit operates at a predetermined temporal rate.

3. The system of claim 1 , wherein each resolution of the control circuit is defined by a number of predefined states.

4. The system of claim 1 , wherein each resolution of the control circuit uses at least one of a predefined deterministic transition state algorithm or a stochastic transition state algorithm.

5. The system of claim 4 , wherein each resolution of the control circuit detects at least one of an abnormal physical condition or an abnormal physiological condition and transitions to a state of absence of stimulation in response to this detection.

6. The system of claim 4 , wherein each resolution of the control circuit determines possible transitions between the plurality of states, in a regular and predetermined manner over time or upon an occurrence of one or more predetermined events.

7. The system of claim 1 , wherein the sensor detects at least one of a cardiac, muscular or nervous electrogram signal; a body, cardiac or muscular, acceleration signal; a respiratory bioimpedance signal; a cardiac signal and a pressure signal; a temperature signal; a piezometric pressure signal or a cardiac contractility signal.

8. The system of claim 7 , wherein the at least one of the current physiological level or the current physical level is determined from a variable corresponding to at least one of a heart rate, a sinus rhythm variability, a blood pressure, a cardiac contractility, a physical activity, a temperature, a movement, or a respiratory rate.

9. A pacing therapy device comprising:
a stimulation device; and
a control circuit that causes the stimulation device to provide stimulation according to a set of stimulation parameters, wherein the control circuit uses a state transition model to modify at least one of a current physical level or a current physiological level and comprises:
a memory having the state transition model stored thereon, comprising a transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and a connection matrix defining whether transitions between pairs of states are permitted, wherein the control circuit has multiresolution capability such that the control circuit can operate at different temporal and/or spatial resolutions to estimate a set of pacing parameters to bring the at least one of the current physiological level or the current physical level to a reference level, wherein the plurality of states of the state transition model are defined by a set of stimulation parameters and at least one of an expected physiological response or an expected physical response during stimulation with the set of stimulation parameters;
a state transition controller that determines transitions from a current state to a new state, causing a corresponding change in the set of stimulation parameters; and
a parameter fusion circuit that defines a final set of stimulation parameters based on parameters estimated by each of the resolutions of the control circuit.

10. The device of claim 9 , wherein each resolution of the control circuit operates at a predetermined temporal rate.

11. The device of claim 9 , wherein each resolution of the control circuit is defined by a number of predefined states.

12. The device of claim 9 , wherein each resolution of the control circuit uses at least one of a predefined deterministic transition state algorithm or a stochastic transition state algorithm.

13. The device of claim 12 , wherein each resolution of the control circuit detects at least one of an abnormal physical condition or an abnormal physiological condition and transitions to a state of absence of stimulation in response to this detection.

14. The device of claim 12 , wherein each resolution of the control circuit determines possible transitions between the plurality of states, in a regular and predetermined manner over time or upon an occurrence of one or more predetermined events.

15. The device of claim 9 , further comprising a sensor that detects at least one of a cardiac, muscular or nervous electrogram signal; a body, cardiac or muscular, acceleration signal; a respiratory bioimpedance signal; a cardiac signal and a pressure signal; a temperature signal; a piezometric pressure signal or a cardiac contractility signal.

16. The device of claim 15 , wherein the at least one current physiological level or current physical level is determined from a variable corresponding to at least one of a heart rate, a sinus rhythm variability, a blood pressure, a cardiac contractility, a physical activity, a temperature, a movement, or a respiratory rate.

17. A method comprising:
applying stimulation according to a set of stimulation parameters;
receiving a signal comprising at least one of a physiological signal or a physical signal;
determining at least one of a current physiological level or a current physical level based on the signal; and
modifying the stimulation using a state transition model comprising a transition matrix defining conditions for transitioning between particular states of a plurality of states of the state transition model and a connection matrix defining whether transitions between pairs of states are permitted, wherein the plurality of states of the state transition model are defined by a set of stimulation parameters and at least one of an expected physiological response or an expected physical response when stimulation is applied by:
estimating a set of stimulation parameters to bring the at least of the current ph

Assignees

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

Inventors

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

Classifications

• A61N1/36053

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

• A61N1/37235

  Aspects of the external programmer · CPC title

• A61N1/36125

  Details of circuitry or electric components · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/36139 Primary

  with automatic adjustment · CPC title