Neurostimulator with activation based on changes in body temperature

• US 7,366,571 B2
• Filed: 12/10/2004
• Issued: 04/29/2008
• Est. Priority Date: 12/10/2004
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Primary Examiner(s): Schaetzle; Kennedy J.
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/009,122
• Publication Number:
  US 20060129202A1
• Time in Patent Office: 1,236 Days
• Field of Search: 607 45- 46, 607 1- 3, 607/21, 607/62, 607/48, 607/105, 607/113, 607/116, 600/549, 600544-545, 600300-301, 340/575, 340/584, 340/573.1, 340/588, 374/100, 374102-103
• 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

Improved methods and devices are provided for detecting and/or predicting the onset of an undesirable physiological event or neural state, such as an epileptic seizure, to 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 sudden change in a body temperature parameter. The temperature parameter change may comprise an increase or decrease in the patient'"'"'s body temperature, time rate of change of body temperature, or a difference in a moving average temperature for a first period from that of a second period. 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 the body temperature of the patient;

determining a time rate of change of body temperature for the patient over at least one predetermined time period;

comparing the time rate of change of the patient'"'"'s temperature with a threshold time rate of change of temperature; and

providing an electrical neurostimulation therapy to a cranial nerve of the patient if the time rate of change of the patient'"'"'s body temperature exceeds said threshold time rate of change, wherein the threshold time rate of change comprises a maximum rate of temperature change associated with the patient.

2. The method of claim 1, wherein said cranial nerve is selected from the group consisting of a vagus nerve, a trigeminal nerve, or a glossopharyngeal nerve.

3. The method of claim 1 wherein said step of providing an electrical neurostimulation therapy comprises changing a parameter of a neurostimulation therapy selected from the group consisting of current amplitude, a cycle on-time and a cycle off-time.

4. The method of claim 3 wherein said step of changing a parameter comprises increasing the current amplitude.

5. The method of claim 3 wherein said step of changing a parameter comprises increasing the cycle on-time.

6. The method of claim 1 wherein said at least one predetermined time period comprises a time period within the range of 15 seconds to 24 hours.

7. The method of claim 1 wherein said step of generating a time series of temperature data comprises sensing body temperature of the patient with an implanted temperature sensor.

8. The method of claim 7 further comprising a step of storing said time series temperature data in a memory.

9. The method of claim 7 wherein said step of determining a time rate of change of body temperature for the patient comprises determining a time rate of change over a plurality of time periods.

10. The method of claim 9 wherein said plurality of time periods comprise time periods selected from the group consisting of 15 seconds, 30 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours and 24 hours.

11. The method of claim 1 wherein said step of determining a time rate of change of body temperature comprises analyzing said time series of temperature data to determine a maximum time rate of change in a selected time interval within said at least one predetermined time period.

12. The method of claim 1 wherein said step of determining a time rate of change of body temperature comprises determining a difference between the temperature at a beginning of one of said at least one predetermined time periods and the temperature at the end of said one of said at least one predetermined time periods, and dividing said difference by the duration of said one of said at least one predetermined time period.

13. The method of claim 1 wherein said step of determining a time rate of change of body temperature comprises determining the difference between the minimum temperature and the maximum temperature within one of said at least one time period and dividing said difference by the time interval separating said minimum and said maximum temperatures.

14. The method of claim 1 wherein said threshold rate of change comprises a predetermined threshold rate of change.

15. The method of claim 1 wherein said threshold rate of change comprises a maximum rate of temperature change associated with physical exercise by the patient.

16. The method of claim 1 further comprising the step of testing the patient with an exercise test to determine a maximum rate of body temperature change over a predetermined exercise time period, and wherein said maximum rate of body temperature change comprises said threshold time rate of change.

17. A method of determining a physiological marker for an epileptic seizure in a patient comprising:

generating a first time series of temperature data representative of the body temperature of the patient,

determining a time rate of change of body temperature for the patient over at least one predetermined time period;

comparing the time rate of change of the patient'"'"'s temperature with a threshold time rate of change of temperature; and

wherein the threshold time rate of change comprises a maximum rate of temperature change associated with the patient.

18. The method of claim 17 further comprising the step of storing said time series temperature data in a memory.

19. The method of claim 17 wherein said step of determining at least one temperature marker comprises determining a maximum rate of change of temperature.

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

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

determining when an undesired physiological event has occurred in the patient;

analyzing the first time series temperature data for a first predetermined time interval preceding the occurrence of the undesired physiological event to determine at least one temperature marker in the data stream as a predictor of the undesired physiological event;

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

analyzing the second time series temperature data stream for the presence of the at least one temperature marker; and

providing an electrical neurostimulation therapy to said cranial nerve of the patient in response to detecting the presence of said at least one temperature marker in said second time series temperature data stream wherein detecting the presence of said at least one temperature marker in the said time series temperature data stream comprises comparing at least a portion of said second time series temperature data stream to a threshold time series of temperature data associated with the patient.

21. The method of claim 20 wherein said step of providing an electrical neurostimulation therapy to the patient comprises changing a parameter of a previous neurostimulation program to be applied to the patient.

22. The method of claim 21 further comprising the steps of:

generating at least a third time series of data representative of a physiological parameter selected from the group consisting of an action potential in a nerve tissue, a heart parameter, a blood parameter, and brain wave activity;

analyzing the third time series data for a second predetermined time interval preceding the occurrence of the physiological event to determine at least a second marker in the third time series data stream as a predictor of the physiological event;

generating a fourth time series of data representative of the selected physiological parameter;

analyzing the fourth time series temperature data stream for the presence of the second marker; and

providing an electrical neurostimulation therapy to said cranial nerve of the patient in response to detecting at least one of the presence of said at least one temperature marker in said second time series temperature data stream and the presence of said second marker in the fourth time series data stream.

23. The method of claim 22 wherein said electrical neurostimulation therapy is applied to the patient only in response to the detection of both of said temperature marker and said second marker.

24. The method of claim 20 wherein said cranial nerve is selected from the group consisting of the vagus nerve, the trigeminal nerve, and the glossopharyngeal nerve.

25. The method of claim 20 wherein said step of generating a first time series of temperature data comprises sensing body temperature of the patient with a temperature sensor at a desired sensing rate.

26. The method of claim 20 wherein said undesired physiological event is an epileptic seizure.

27. A neurostimulator system for providing a neurostimulation therapy to a cranial nerve of a patient comprising:

a pulse generator capable of generating an electrical signal for stimulation of a neural structure in a patient,

a stimulation electrode assembly coupled to said pulse generator and to said neural structure, said stimulation electrode adapted for delivering said electrical signal to said neural structure,

a controller to regulate delivery of said electrical stimulation to said neural structure, said controller comprising a temperature sensing unit, said temperature sensing unit comprising

a temperature sensor element;

timing circuitry, said circuitry operating to control the rate at which said temperature element senses body temperature and to generate a first time series of temperature data preceding the occurrence of a physiological event and a second time series of temperature data after said event,

temperature analysis circuitry, said circuitry operating to analyze said first time series of temperature data to determine a marker of a physiological event, and said second time series of temperature data to detect the presence of said marker, and

activation circuitry for causing said pulse generator to provide said electrical signal to said neural structure if said marker is detected in said second time series of temperature data, wherein detecting the marker in the said time series temperature data stream comprises comparing at least a portion of said second time series temperature data stream to a threshold time series of temperature data associated with the patient.

28. The neurostimulator system of claim 27 wherein said neural structure comprises at least one nerve selected from the group consisting of a vagus nerve, a trigeminal nerve, and a glossopharyngeal nerve.

29. The neurostimulator system of claim 27 wherein said pulse generator is implanted in said patient and said stimulation electrode assembly is coupled to said pulse generator by a lead assembly.

30. The neurostimulator system of claim 27 wherein said pulse generator is implanted in said patient and said stimulation electrode assembly is coupled to said pulse generator by a radio frequency transmitter and receiver.

31. The neurostimulator system of claim 27 wherein said temperature sensor comprises an implanted sensor coupled to said pulse generator by a lead assembly.

32. The neurostimulator system of claim 27 wherein said temperature sensor comprises a sensor that is part of an integrated circuit chip.

33. The neurostimulator system of claim 27 wherein said controller comprises hardware and at least one of firmware and software.

34. The neurostimulator system of claim 27, wherein said marker comprises a time rate of temperature change exceeding a threshold time rate of temperature change.

35. The neurostimulator of claim 34 wherein said threshold time rate of temperature change comprises a maximum time rate of temperature change associated with physical exercise by said patient.

36. The neurostimulator of claim 27 wherein said marker comprises a difference in moving average temperature from a first time domain to a second time domain.

37. The neurostimulator of claim 27 wherein said first time domain comprises ten minutes and a second time domain comprises two minutes.

38. The neurostimulator of claim 27, further comprising a memory element for storing temperature data.

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

generating a first time series of temperature data representative of the body temperature of the patient,

determining from the first time series of temperature data a body temperature parameter selected from the group consisting of a time rate of change of body temperature and a difference in a moving average body temperature for a first time domain and a moving average body temperature for a second time domain,

comparing the body temperature parameter to a threshold for the body temperature parameter, and

if the body temperature parameter exceeds said threshold, providing electrical neurostimulation pulses to a cranial nerve of the patient, said threshold for the body temperature parameter comprises a maximum body temperature associated with the patient.

40. The method of claim 39, wherein said step of providing electrical neurostimulation pulses comprises changing a parameter of an electrical neurostimulation therapy to be delivered to said cranial nerve.