Use of cardiac parameters in methods and systems for treating a chronic medical condition

• US 8,239,028 B2
• Filed: 04/24/2009
• Issued: 08/07/2012
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Scott, Timothy L.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/429,998
• Publication Number:
  US 20100274308A1
• Time in Patent Office: 1,201 Days
• Field of Search: None
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• 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 1/36592 controlled by the heart rate variability

Abstract

Disclosed herein are methods, systems, and apparatus for treating a chronic medical condition in a patient. A time of beat sequence of the patient'"'"'s heart is determined. A regulatory system parameter is determined based on the time of beat sequence. The parameter is indicative of a stress level of the patient'"'"'s regulatory adaptation systems. The determined regulatory system parameter is compared with a threshold regulatory system parameter value. An electrical signal is applied to a neural structure of the patient to treat the chronic medical condition if the determined regulatory system parameter exceeds the threshold regulatory system parameter value.

Claims

1. A method of adapting treatment of a patient having a chronic medical condition during periods of heightened stress on regulatory adaptation systems of the patient, comprising:

applying a first electrical signal to a neural structure of the patient to treat the chronic medical condition, the first electrical signal defined by a first set of signal parameter values;

determining a time of beat sequence of the patient'"'"'s heart;

determining a first index of activity of regulatory systems (IARS) value based on said time of beat sequence, the first IARS value indicative of a stress level of the regulatory adaptation systems of the patient;

comparing the first IARS value to a first IARS threshold; and

adjusting the first electrical signal to provide a second electrical signal to the neural structure of the patient in response to the first IARS value exceeding the first IARS threshold, the second electrical signal defined by a second set of signal parameter values, wherein at least one value of the second set of signal parameter values is different from a corresponding value in the first set of signal parameter values.

2. The method of claim 1, wherein the first IARS threshold is an adaptive threshold that changes in response to at least one factor selected from among a circadian rhythm of the patient, a time of day, a cardiac parameter other than IARS derived from said time of beat sequence, a blood parameter measured for the patient, a health status of the patient, and a baseline IARS value for the patient.

3. The method of claim 1, wherein the neural structure comprises at least one neural structure selected from among a brain structure of the patient, a cranial nerve of the patient, a spinal cord of the patient, a sympathetic nerve structure of the patient, and a peripheral nerve of the patient.

4. The method of claim 1, wherein the chronic medical condition comprises at least one chronic medical condition selected from among traumatic brain injury;

complications from stroke;

chronic cardiac disorders (including congestive heart failure);

obesity;

a neuropsychiatric disorder selected from the group consisting of schizophrenia, depression, and borderline personality disorder;

multiple sclerosis;

fibromyalgia; and

arthritis.

5. The method of claim 1, further comprising:

comparing the first IARS value to a second threshold IARS value in response to determining that the first IARS value exceeds the first threshold IARS value; and

adjusting the first electrical signal to provide a third electrical signal to the neural structure of the patient in response to the first IARS value exceeding the second threshold IARS value, the third electrical signal defined by a third set of signal parameter values, wherein at least one value of the third set of signal parameter values is different from a corresponding value in the first set of signal parameter values and the second set of signal parameter values.

6. The method of claim 1, further comprising:

determining a second IARS value for said patient after providing the second electrical signal to the neural structure of the patient;

comparing the second IARS value to the first threshold IARS value;

adjusting the second electrical signal to provide the first electrical signal to the neural structure of the patient in response to the second IARS value being less than or equal to the first threshold IARS value.

7. The method of claim 1, further comprising:

calculating a first baseline IARS value for the patient having the chronic medical condition.

8. The method of claim 7, further comprising:

determining the first threshold IARS value based on the first baseline IARS value.

9. The method of claim 8, further comprising:

modifying the first baseline IARS value to provide a second baseline IARS value based on a change in an environmental parameter, a patient-specific parameter, or a combination thereof; and

adjusting the first threshold IARS value to provide a new first threshold IARS value based on the second baseline IARS value.

10. The method of claim 1, wherein the at least one value of the second set of signal parameter values that is different from a corresponding value in the first set of signal parameter values is for at least one corresponding parameter selected from among a current amplitude, a pulse-width, a frequency, an on-time, and an off-time.

11. A non-transitory computer readable program storage device encoded with instructions that, when executed by a computer, performs a method of adapting treatment of a patient having a chronic medical condition during periods of heightened stress on regulatory adaptation systems of the patient, the method comprising:

providing a first electrical signal to a neural structure of the patient to treat the chronic medical condition, the first electrical signal defined by a first set of signal parameter values;

determining a time of beat sequence of the patient'"'"'s heart;

determining a first index of regulatory activity systems (IARS) value associated with the patient based upon the time of beat sequence;

comparing the first IARS value to a first threshold IARS value;

comparing the first IARS value to a second threshold IARS value in response to determining that the first IARS value exceeds the first threshold IARS value; and

adjusting the first electrical signal to provide a second electrical signal to the neural structure of the patient in response to the first IARS value exceeding the first threshold IARS value and not exceeding the second threshold IARS value, the second electrical signal defined by a second set of signal parameter values, wherein at least one value of the second set of signal parameter values is different from a corresponding value in the first set of signal parameter values.

12. The non-transitory computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 11, further comprising:

adjusting the first electrical signal to provide a third electrical signal to the neural structure of the patient in response to the first IARS value exceeding the second threshold IARS value, the third electrical signal defined by a third set of signal parameter values, wherein at least one value of the third set of signal parameter values is different from a corresponding value in the first set of signal parameter values and the second set of signal parameter values.

13. The non-transitory computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 11, further comprising:

determining a second IARS value for said patient after providing the second electrical signal to the neural structure of the patient;

comparing the second IARS value to the first threshold IARS value; and

adjusting the second electrical signal to provide the first electrical signal to the neural structure of the patient in response to the second IARS value being less than or equal to the first threshold IARS value.

14. The non-transitory computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 11, wherein the chronic medical condition is at least one condition selected from among a traumatic brain injury;

complications from stroke;

a chronic cardiac disorder;

obesity;

a neuropsychiatric disorder selected from the group consisting of schizophrenia, depression, and borderline personality disorder;

multiple sclerosis;

fibromyalgia; and

arthritis.

15. A method adapting treatment of a patient having a chronic medical condition during periods of heightened stress on regulatory adaptation systems of the patient, the chronic medical condition being selected from among traumatic brain injury, depression, and fibromyalgia, the method comprising:

applying a first electrical signal to a cranial nerve of the patient to treat the chronic medical condition, the first electrical signal defined by a first set of signal parameter values;

determining a time of beat sequence of the patient'"'"'s heart by sensing the time of beat sequence of the patient'"'"'s heart and processing the data relating to the beat sequence to generate a time series data stream from said time of beat sequence;

determining a first index of activity of regulatory systems (JARS) value based on said time of beat sequence, wherein said value is indicative of a stress level of the regulatory adaptation systems of the patient;

comparing said determined first IARS value with a first threshold IARS value; and

adjusting the first electrical signal to provide a second electrical signal to the cranial nerve of the patient to treat the chronic medical condition in response to the first IARS value exceeding the first threshold IARS value, the second electrical signal defined by a second set of signal parameter values, wherein at least one value of the second set of signal parameter values is different from a corresponding value in the first set of signal parameter values.

16. The method of claim 15, wherein the first threshold IARS value is an adaptive threshold that changes in response to at least one factor selected from among a circadian rhythm of the patient, a time of day, a cardiac parameter other than IARS derived from said time of beat sequence, a blood parameter measured for the patient, a health status of the patient, and a baseline IARS value for the patient.

17. The method of claim 15, further comprising:

comparing the first IARS value to a second threshold IARS value in response to determining that the second IARS value exceeds the first threshold IARS value; and

adjusting the first electrical signal to provide a third electrical signal to the cranial nerve of the patient in response to the first IARS value exceeding the second threshold IARS value, the third electrical signal defined by a third set of signal parameter values, wherein at least one value of the third set of signal parameter values is different from a corresponding value in the first set of signal parameter values and the second set of signal parameter values.

18. The method of claim 15, further comprising:

determining a second IARS value for said patient after providing the second electrical signal to the cranial nerve of the patient;

comparing the second IARS value to the first threshold IARS value; and

adjusting the second electrical signal to provide the first electrical signal to the cranial nerve of the patient in response to the second IARS value being less than or equal to the first threshold IARS value.

19. The method of claim 15, further comprising:

calculating a first baseline IARS value for the patient having the chronic medical condition;

determining the first threshold IARS value based on the first baseline IARS value;

recalculating the first baseline IARS value to provide a second baseline IARS value for the patient, the second baseline IARS value different from the first baseline IARS value; and

adjusting the first threshold IARS value to provide a new first threshold IARS value based on the second baseline IARS value.

20. The method of claim 19, further comprising:

determining the first threshold IARS value based on the first baseline IARS value.

21. The method of claim 20, further comprising:

modifying the first baseline IARS value to provide a second baseline IARS value based on a change in an environmental parameter, a patient-specific parameter, or a combination thereof; and

adjusting the first threshold IARS value to provide a new first threshold IARS value based on the second baseline IARS value.

22. The method of claim 15, wherein the at least one value of the second set of signal parameter values that is different from a corresponding value in the first set of signal parameter values is for at least one corresponding parameter selected from among a current amplitude, a pulse-width, a frequency, an on-time, and an off-time.

23. A medical device for adapting treatment of a patient having a chronic medical condition during periods of heightened stress on regulatory adaptation systems of the patient, comprising:

an electrical signal module configured to apply a first electrical signal to a neural structure of the patient to treat the chronic medical condition, the first electrical signal defined by a first set of signal parameter values;

a heart beat data processing module configured to determine a time of beat sequence of the patient'"'"'s heart;

a heart parameter module configured to determine an index of activity of regulatory systems (JARS) value based on said time of beat sequence, the IARS value indicative of a stress level of the regulatory adaptation systems of the patient; and

a comparator configured to compare the IARS value to a first IARS threshold;

wherein the electrical signal module configured to adjust the first electrical signal to provide a second electrical signal to the neural structure of the patient in response to the IARS value exceeding the first IARS threshold, the second electrical signal defined by a second set of signal parameter values, wherein at least one value of the second set of signal parameter values is different from a corresponding value in the first set of signal parameter values.

24. The medical device of claim 23, further comprising:

a memory unit configured to store the IARS value; and

a communications module configured to notify the patient, a healthcare provider, or both when the IARS value exceeds the first IARS threshold.

25. The medical device of claim 23, further comprising a lead interface, the lead interface being configured to provide the electrical signal to a lead configured to operatively couple, using an electrode, to at least one neural structure selected from among a portion of a brain structure of the patient, a cranial nerve of the patient, a spinal cord of the patient, a sympathetic nerve structure of the patient, and a vagus nerve of the patient.

26. The medical device of claim 23, wherein the chronic medical condition is at least one condition selected from among a traumatic brain injury;

complications from stroke;

a chronic cardiac disorder;

obesity;

a neuropsychiatric disorder selected from the group consisting of schizophrenia, depression, and borderline personality disorder;

multiple sclerosis;

fibromyalgia; and

arthritis.

27. The medical device of claim 23, wherein the heart parameter module is configured to determine the first threshold IARS value based on the first baseline IARS value.

28. The medical device of claim 27, wherein the heart parameter module is configured to modify the first baseline IARS value to provide a second baseline IARS value based on a change in at least one of an environmental parameter and a patient-specific parameter, the heart parameter module further configured to adjust the first threshold IARS value to provide a new first threshold IARS value based on the second baseline IARS value.

29. The medical device of claim 23, wherein the at least one value of the second set of signal parameter values that is different from a corresponding value in the first set of signal parameter values is for at least one corresponding parameter selected from among a current amplitude, a pulse-width, a frequency, an on-time, and an off-time.

30. A medical device for adapting treatment of a patient having a chronic medical condition during periods of heightened stress on regulatory adaptation systems of the patient, comprising:

an electrical signal module configured to apply a first electrical signal to a cranial nerve of the patient to treat the chronic medical condition, the first electrical signal defined by a first set of signal parameter values;

a heart beat data processing module configured to determine a time of beat sequence of the patient'"'"'s heart by sensing the time of beat sequence of the patient'"'"'s heart and processing the data relating to the beat sequence to generate a time series data stream from said time of beat sequence;

a heart parameter module configured to determine a first index of activity of regulatory systems (JARS) value based on said time of beat sequence, the first IARS value indicative of a stress level of the regulatory adaptation systems of the patient; and

a comparator configured to compare the first IARS value to a first IARS threshold;

wherein the electrical signal module configured to adjust the first electrical signal to provide a second electrical signal to the cranial nerve of the patient in response to the first IARS value exceeding the first IARS threshold, the second electrical signal defined by a second set of signal parameter values, wherein at least one value of the second set of signal parameter values is different from a corresponding value in the first set of signal parameter values.

31. The medical device of claim 30, further comprising:

a memory unit configured to store the first IARS value; and

a communications module configured to notify the patient, a healthcare provider, or both when the first IARS value exceeds the first IARS threshold.