UNIDIRECTIONAL NEURAL STIMULATION SYSTEMS, DEVICES AND METHODS

• US 20080243196A1
• Filed: 04/02/2007
• Published: 10/02/2008
• Est. Priority Date: 04/02/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Scheiner, Avram, Libbus, Imad
• Granted Patent: US 8,224,436 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

An embodiment relates to a method for delivering a unidirectional afferent nerve stimulation treatment. A test neural stimulation is delivered, and a physiologic response to the test neural stimulation is monitored. At least one neural stimulation parameter for the test neural stimulation is adjusted if the test neural stimulation does not elicit a desired physiologic response. If the test neural stimulation does elicit the desired physiologic response, at least one treatment parameter for a unidirectional afferent nerve stimulation is determined using the at least one neural stimulation parameter for the test neural stimulation that provided the desired physiologic response. The unidirectional afferent nerve stimulation is delivered using the at least one treatment parameter.

Claims

1. A method for delivering a unidirectional afferent nerve stimulation treatment, comprising:

delivering a test neural stimulation;

monitoring a physiologic response to the test neural stimulation;

adjusting at least one neural stimulation parameter for the test neural stimulation if the test neural stimulation does not elicit a desired physiologic response;

if the test neural stimulation does elicit the desired physiologic response, determining at least one treatment parameter for a unidirectional afferent nerve stimulation using the at least one neural stimulation parameter for the test neural stimulation that provided the desired physiologic response; and

delivering the unidirectional afferent nerve stimulation using the at least one treatment parameter.

2. The method of claim 1, wherein delivering the unidirectional afferent nerve stimulation includes delivering the unidirectional afferent nerve stimulation through a tripolar electrode.

3. The method of claim 1, wherein:

delivering a test neural stimulation includes delivering a unidirectional efferent neural stimulation of a target nerve to provide a physiological response capable of being sensed; and

delivering the unidirectional afferent nerve stimulation includes delivering unidirectional afferent nerve stimulation of the target nerve.

4. The method of claim 1, wherein:

delivering a test neural stimulation includes delivering a general neural stimulation of a target nerve to provide a physiological response capable of being sensed; and

delivering the unidirectional afferent nerve stimulation includes delivering unidirectional afferent nerve stimulation of the target nerve.

5. The method of claim 1, wherein:

delivering a test neural stimulation includes delivering test neural stimulation using at least one electrode; and

delivering the unidirectional afferent nerve stimulation includes delivering unidirectional afferent nerve stimulation using the at least one electrode.

6. The method of claim 1, further comprising declaring a failure of a neural stimulation pathway if the test neural stimulation does not elicit a desired physiologic response.

7. The method of claim 1, wherein delivering the unidirectional afferent nerve stimulation is intermittently interrupted according to a schedule to deliver the test neural stimulation.

8. The method of claim 1, wherein delivering the unidirectional afferent nerve stimulation is automatically interrupted to deliver the test neural stimulation in response to a condition.

9. The method of claim 1, wherein delivering the unidirectional afferent nerve stimulation is manually interrupted to deliver the test neural stimulation.

10. The method of claim 1, wherein monitoring a physiologic response to the test neural stimulation includes monitoring at least one response from the group of responses comprising:

a blood pressure response;

a heart rate response, and a laryngeal vibration response.

11. A method for delivering a unidirectional afferent vagal stimulation treatment, comprising:

delivering unidirectional efferent neural stimulation to a vagus nerve;

monitoring a physiologic response to the unidirectional efferent neural stimulation;

adjusting at least one neural stimulation parameter for the unidirectional efferent neural stimulation if the test neural stimulation does not elicit a desired physiologic response;

if the unidirectional efferent neural stimulation does elicit the desired physiologic response, determining at least one treatment parameter for a unidirectional afferent nerve stimulation using the at least one neural stimulation parameter for the unidirectional efferent neural stimulation that provided the desired physiologic response; and

delivering the unidirectional afferent nerve stimulation using the at least one treatment neural stimulation parameter.

12. The method of claim 11, wherein:

delivering unidirectional efferent neural stimulation to a vagus nerve includes delivering neural stimulation using a tripolar electrode with a cathode, a first anode and a second anode; and

delivering the unidirectional afferent nerve stimulation includes delivering neural stimulation using the tripolar lead.

13. The method of claim 12, wherein determining at least one treatment parameter for a unidirectional afferent nerve stimulation using the at least one neural stimulation parameter for the unidirectional efferent neural stimulation includes adjusting the stimulation parameters of the first and second anodes such that a first anodal current associated with the first anode during the efferent stimulation is approximately the second anodal current associated with the second anode during the afferent stimulation, and the second anodal current associated with the second anode during efferent stimulation is approximately the first anodal current associated with the first anode during the afferent stimulation.

14. The method of claim 11, wherein monitoring a physiologic response includes monitoring at least one response from the group of responses comprising:

a blood pressure response;

a heart rate response, and a laryngeal vibration response.

15. The method of claim 11, wherein delivering the unidirectional afferent nerve stimulation includes delivering the unidirectional afferent nerve stimulation as part of a heart failure treatment, a hypertension treatment or a post-myocardial infarction treatment.

16. A method for delivering a unidirectional afferent nerve stimulation treatment, comprising:

delivering unidirectional afferent nerve stimulation to a target nerve using at least one electrode;

interrupting delivery of the unidirectional afferent nerve stimulation to deliver a test neural stimulation to the target nerve using the at least one electrode;

monitoring a physiologic response to the test neural stimulation; and

declaring a failure of a neural stimulation pathway if the test neural stimulation does not elicit a desired physiologic response.

17. The method of claim 16, wherein interrupting delivery of the unidirectional afferent nerve stimulation to deliver a test neural stimulation to the target nerve includes delivering a unidirectional efferent neural stimulation to the target nerve.

18. The method of claim 16, wherein the target nerve is a vagus nerve.

19. A system, comprising:

a neural stimulator adapted to generate neural stimulation signals for use in delivering neural stimulation;

a controller connected to the neural stimulator, the controller and the neural stimulator being adapted to generate a first neural stimulation signal for use in delivering unidirectional afferent neural stimulation to a target nerve for a neural stimulation therapy, and to generate a second neural stimulation signal for use in delivering efferent neural stimulation to the target nerve;

at least one sensor adapted to sense a physiologic response to the efferent neural stimulation of the target nerve; and

the controller being connected to the at least one sensor, the controller being adapted to compare a sensed physiologic response to the efferent neural stimulation to a desired response, and adjust at least one efferent neural stimulation parameter for the second neural stimulation signal for use in delivering efferent neural stimulation that results in the desired physiologic response, the controller further being adapted to deliver the unidirectional afferent neural stimulation using afferent neural stimulation parameters determined using the at least one efferent neural stimulation parameter that provided the desired physiological response.

20. The system of claim 19, wherein the neural stimulator is adapted to generate neural stimulation signals for use in delivering neural stimulation using a tripolar electrode.

21. The system of claim 19, wherein the controller and the neural stimulator are adapted to generate the first neural stimulation signal for use in delivering unidirectional afferent neural stimulation to a vagus nerve, and to generate a second neural stimulation signal for use in delivering efferent neural stimulation to the vagus nerve.

22. The system of claim 21, wherein controller and the neural stimulator are adapted to generate a first test neural stimulation signal for use in delivering unidirectional afferent neural stimulation to a left vagus nerve and a second test neural stimulation signal for use in delivering unidirectional afferent stimulation to a right vagus nerve, and to generate a first treatment neural stimulation signal for use in delivering efferent neural stimulation to the left vagus nerve and a second treatment neural stimulation signal for use in delivering efferent neural stimulation to the right vagus nerve.

23. The system of claim 19, wherein the controller is adapted to interrupt delivering unidirectional afferent neural stimulation to the target nerve to deliver efferent neural stimulation.

24. The system of claim 19, wherein the controller is adapted to automatically interrupt delivering unidirectional afferent neural stimulation according to a schedule.

25. The system of claim 19, wherein the controller is adapted to automatically interrupt delivering unidirectional afferent neural stimulation in response to a device event.

26. The system of claim 19, wherein the controller is adapted to interrupt delivering unidirectional afferent neural stimulation in response to a manually-initiated command.