Neurostimulation with activation based on changes in body temperature

• US 7,643,881 B2
• Filed: 01/20/2006
• Issued: 01/05/2010
• Est. Priority Date: 12/10/2004
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/336,453
• Publication Number:
  US 20060142802A1
• Time in Patent Office: 1,446 Days
• Field of Search: 607 1- 3, 607/45, 607/48, 607/105, 607/113, 607/116, 600300-301, 600544-545, 600/549
• US Class Current: 607/45
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

Methods and devices for detecting and/or predicting onset of an undesirable physiological event or neural state, such as an epileptic seizure, facilitate rapid intervention with a treatment therapy such as neurostimulation or drug therapy. The methods and devices involve monitoring the patient'"'"'s body temperature, preferably by an implanted temperature sensor, to detect a change in a body temperature parameter over a first time period, which may comprise an increase or decrease in the patient'"'"'s body temperature, time rate of change of body temperature, moving average temperature, increase or decrease in body temperature exceeding a target temperature, elevated or reduced body temperature, or temperature stability parameter over a first time period. The sampling period may be changed manually or depending upon a sensed body parameter, including temperature. When a parameter change is detected that exceeds a threshold, neurostimulation therapy is delivered to a neural structure of the patient.

Claims

1. A method of providing electrical neurostimulation therapy to a cranial nerve of a patient comprising:

generating a time series of temperature data representative of a body temperature of the patient;

determining from said data at least two body temperature parameters for the patient over at least one predetermined time period, wherein said at least two body temperature parameters include first and second body temperature parameters;

comparing the at least two body temperature parameters with respective thresholds, wherein said respective thresholds include first and second thresholds; and

providing an electrical signal directly to a cranial nerve of the patient contingent upon;

(i.) said first body temperature parameter exceeding the first threshold; and

(ii.) said second body temperature parameter exceeding the second threshold.

2. The method of claim 1 wherein said at least two body temperature parameters are selected from the group consisting of a time rate of change of temperature over the first predetermined time period, a moving average temperature over the first predetermined time period, a rise in body temperature exceeding a first magnitude over the first predetermined time period, a drop in body temperature exceeding a first magnitude over the first predetermined time period, a body temperature exceeding a first target temperature for the first predetermined time period, a body temperature below a first target temperature for first predetermined time period, a minimum rate of change of body temperature during the first predetermined time period, a maximum rate of change of body temperature during the first predetermined time period, and a temperature stability parameter for the first predetermined time period.

3. The method of claim 2 wherein said temperature stability parameter comprises a duration that body temperature is within a first temperature range, a duration that body temperature is outside a first temperature range, a difference between minimum and maximum body temperatures measured during the first predetermined time period, a standard deviation of body temperature measurements taken over the first predetermined time period, a difference between the minimum and maximum rates of change of body temperature during the first predetermined time period, and standard deviation of rates of change of body temperature during the first predetermined time period.

4. The method of claim 1, wherein providing an electrical signal directly to a cranial nerve comprises providing an electrical signal to a vagus nerve, a trigeminal nerve, or a glossopharyngeal nerve.

5. The method of claim 1 wherein said step of providing the electrical signal comprises performing an action selected from the group consisting of:

applying the electrical signal directly to said cranial nerve in response to determining that the at least two body temperature parameters exceed the respective first and second thresholds, and

changing an electrical parameter of said electrical signal directly applied to said cranial nerve in response to determining that the at least two body temperature parameter parameters exceed the respective first and second thresholds,

wherein said electrical parameter is selected from the group consisting of current amplitude, a pulse width, a frequency, a pulse period, a cycle on-time and a cycle off-time.

6. The method of claim 5 wherein changing an electrical parameter comprises changing the electrical parameter in proportion to a change in said at least two body temperature parameters.

7. The method of claim 1 wherein generating a time series of temperature data comprises sensing body temperature of the patient with a temperature sensor, said time series of temperature data having a sampling interval that may be changed by programming the sampling interval and determining that at least said first body temperature parameter exceeds the first threshold.

8. The method of claim 1 further comprising storing said time series temperature data in a memory.

9. The method of claim 1 wherein said at least one predetermined time period comprises a plurality of predetermined time periods.

10. The method of claim 1 wherein said at least one predetermined time period comprises a time period within the group of time periods ranging from 0.01 seconds to 24 hours.

11. The method of claim 1 wherein said first threshold comprises a threshold associated with physical exercise by the patient.

12. The method of claim 11 further comprising testing the patient with an exercise test to determine said first threshold associated with physical exercise.

13. The method of claim 12 wherein said first threshold associated with physical exercise comprises a maximum body temperature achieved during exercise, a maximum rate of increase of body temperature over a predetermined exercise time period, and a time period during which the body temperature exceeds a predetermined target temperature.

14. The method of claim 1 wherein providing said electrical signal directly to said cranial nerve of the patient includes repeatedly applying electrical neurostimulation therapy with a predetermined off time interval between consecutive applications.

15. The method of claim 1 wherein generating a time series of temperature data comprises sensing body temperature of the patient with a temperature sensor, said time series of temperature data having a sampling interval that is adjustable by programming the sampling interval based on at least one of:

time of day, a circadian rhythm of the patient, a heart rate parameter of the patient and a blood parameter of the patient.