SYSTEMS, DEVICES AND METHODS FOR ACUTE AUTONOMIC STIMULATION

• US 20080177190A1
• Filed: 01/18/2007
• Published: 07/24/2008
• Est. Priority Date: 01/18/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Nikles, Stefan, Libbus, Imad
• Granted Patent: US 8,301,239 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Various system embodiments comprise a medical device, comprising a flexible tether, a neural stimulation circuit, and a controller. The flexible tether is adapted to be fed into a patient'"'"'s throat. The flexible tether includes a plurality of electrodes. The neural stimulation circuit is adapted to deliver neural stimulation. The controller is adapted to control the neural stimulation circuit to provide a neural stimulation therapy using at least one electrode from the plurality of electrodes, and to implement a neural stimulation test routine. The neural stimulation test routine is adapted to assess neural stimulation efficacy for electrode subsets of the plurality of electrodes to identify a desired electrode subset for use in delivering the neural stimulation therapy to elicit a desired response.

Claims

1. A medical device, comprising:

a flexible tether adapted to be fed into a patient'"'"'s throat, the flexible tether including a plurality of electrodes;

a neural stimulation circuit adapted to deliver neural stimulation; and

a controller adapted to control the neural stimulation circuit to provide an autonomic neural stimulation therapy using at least one electrode from the plurality of electrodes, the controller being adapted to implement a neural stimulation test routine, the neural stimulation test routine being adapted to assess neural stimulation efficacy for electrode subsets of the plurality of electrodes to identify a desired electrode subset for use in delivering the autonomic neural stimulation therapy to elicit a desired response.

2. The device of claim 1, wherein the electrode subsets include an electrode subset with a single electrode and the desired electrode subset is the electrode subset with the single electrode, the device further comprising at least one counter electrode that is not included with the flexible tether for use in providing at least one stimulation vector between the counter electrode and the single electrode.

3. The device of claim 1, wherein the neural stimulation test routine is adapted to assess neural stimulation efficacy for at least two stimulation vectors available for the desired electrode subset.

4. The device of claim 1, wherein the neural stimulation test routine is adapted to assess neural stimulation efficacy for at least two neural stimulation intensity levels for the desired electrode subset.

5. The device of claim 1, wherein the flexible tether includes at least one lumen adapted to deliver a gas for use by the patient in breathing.

6. The device of claim 1, wherein the plurality of electrodes includes a plurality of electrodes that at least partially circumscribe a circumference of the flexible tether.

7. The device of claim 1, wherein at least some of the plurality of electrodes are adapted for use in detecting heart rate.

8. The device of claim 1, wherein at least some of the plurality of electrodes are adapted for use in detecting an electrocardiogram (ECG) signal.

9. The device of claim 1, wherein the device is a portable device, the portable device including a battery terminal for connection to a battery to power the portable device.

10. The device of claim 1, wherein the neural stimulation test routine is adapted to select a first electrode subset capable of being used in delivering the neural stimulation therapy to elicit the desired response.

11. The device of claim 1, wherein the neural stimulation test routine is adapted to determine at least two electrode subsets capable of being used in delivering the neural stimulation therapy to elicit the desired response and to assess an efficacy of the at least two electrode subsets in eliciting the desired response, the neural stimulation test routine further being adapted to select a electrode subset that the neural stimulation test routine assesses to be most efficacious.

12. The device of claim 1, wherein the flexible tether includes at least two distinct electrode regions, each electrode region including a plurality of electrodes.

13. The device of claim 1, wherein the flexible tether is further adapted to be fed through the patient'"'"'s throat into a pharynx, into a larynx, into an esophagus, or into a trachea.

14. A system, comprising:

means for selecting at least one electrode from a plurality of electrodes located in a pharynx, a larynx, a trachea, or an esophagus of a patient, including means for determining that the selected at least one electrode is effective for use in delivering autonomic neural stimulation to elicit a desired response; and

means for delivering an autonomic neural stimulation therapy using the selected at least one electrode.

15. The system of claim 14, wherein the means for selecting at least one electrode includes:

means for monitoring at least one physiological parameter indicative of the desired response; and

means for delivering the autonomic neural stimulation using different electrodes to identify that the at least one electrode is operationally positioned with respect to the desired neural target to elicit the desired neural response as determined using the at least one physiological parameter.

16. The system of claim 14, wherein the means for selecting at least one electrode includes means for automatically selecting at least two electrodes, and the means for delivering the neural stimulation therapy includes means for transluminally delivering the autonomic neural stimulation using the selected at least two electrodes.

17. The system of claim 14, wherein the means for delivering the autonomic neural stimulation therapy includes means for delivering the autonomic neural stimulation using the selected at least one electrode and a counter electrode.

18. A method, comprising:

identifying an emergency patient as a candidate for post myocardial infarction (post-MI) neural stimulation therapy;

inserting a flexible tether of a portable device into the patient'"'"'s throat, the flexible tether including a plurality of electrodes; and

delivering autonomic neural stimulation to a desired neural target to elicit a desired neural response for the post-MI neural stimulation therapy.

19. The method of claim 18, further comprising initiating a neural stimulation test routine for selecting a subset of electrodes from the plurality of electrodes for use in delivering autonomic neural stimulation to the desired neural target.

20. The method of claim 18, wherein inserting the flexible tether into the patient'"'"'s throat includes inserting the flexible tether through a mouth or through a nose of the patient into the patient'"'"'s throat.

21. The method of claim 18, wherein inserting the flexible tether into the patient'"'"'s throat includes inserting the flexible tether through the patient'"'"'s throat into a pharynx, a larynx, an esophagus, or a trachea.

22. The method of claim 18, further comprising ventilating the patient using a lumen in the flexible tether.

23. A portable medical device, comprising:

a flexible tether adapted to be fed into a patient'"'"'s throat, the flexible tether including at least one neural stimulation element for use in delivering neural stimulation to a neural target;

a neural stimulation circuit adapted to deliver neural stimulation using the at least one neural stimulation element;

a battery terminal adapted to receive at least one battery, the battery terminal being connected to the neural stimulation circuit and the controller to enable the at least battery to power the neural stimulation circuit and the controller; and

a controller adapted to control the neural stimulation circuit to provide an autonomic neural stimulation therapy using the at least one neural stimulation element.

24. The device of claim 23, wherein the flexible tether includes a plurality of neural stimulation elements, and the controller is adapted to implement a neural stimulation test routine to automatically select at least one of the neural stimulation elements to use in delivering the autonomic neural stimulation therapy.

25. The device of claim 23, wherein the flexible tether includes a plurality of neural stimulation elements, and the controller is adapted to implement a neural stimulation test routine to allow a user to select at least one of the neural stimulation elements to use in delivering the autonomic neural stimulation therapy.

26. The device of claim 23, wherein the at least one neural stimulation element includes a neural stimulation element selected from the group consisting of:

an electrode;

a transducer adapted to deliver ultrasound energy;

a transducer adapted to deliver light energy;

a transducer adapted to deliver magnetic energy; and

a transducer adapted to deliver thermal energy.