USE OF CARDIAC PARAMETERS IN METHODS AND SYSTEMS FOR TREATING A CHRONIC MEDICAL CONDITION

• US 20100274308A1
• Filed: 04/24/2009
• Published: 10/28/2010
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Scott, Timothy L.
• Granted Patent: US 8,239,028 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• 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 treating a chronic medical condition in a patient, comprising:

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

determining a regulatory system parameter based on said time of beat sequence, wherein said parameter is indicative of a stress level of the patient'"'"'s regulatory adaptation systems;

comparing said determined regulatory system parameter with a threshold regulatory system parameter value; and

applying an electrical signal to a neural structure of the patient to treat the chronic medical condition if said determined regulatory system parameter exceeds said threshold regulatory system parameter value.

2. The method of claim 1, wherein determining the time of beat sequence of the patient'"'"'s heart comprises sensing a time of beat sequence of a 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.

3. The method of claim 1, wherein determining the regulatory system parameter associated comprises determining an index of activity of regulatory systems (IARS) value for the patient.

4. The method of claim 1, wherein said threshold regulatory system parameter value is an adaptive threshold that changes in response to at least one of a circadian rhythm of the patient, a time of day, a cardiac parameter 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.

5. The method of claim 1, wherein applying an electrical signal to a neural structure comprises applying an electrical signal to at least one 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, or a peripheral nerve of the patient.

6. The method of claim 1, wherein applying the electrical signal to a neural structure to treat a chronic condition comprises applying the electrical signal to treat at least one of traumatic brain injury;

complications from stroke;

chronic cardiac disorders (such as congestive heart failure);

obesity;

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

multiple sclerosis;

fibromyalgia; and

arthritis.

7. A method of treating a chronic medical condition in a patient, comprising:

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

determining a heart rate variability (HRV) parameter based on said time of beat sequence, wherein said HRV parameter is associated with a parasympathetic function of the patient;

comparing said determined HRV parameter with a threshold HRV parameter value; and

applying an electrical signal to a neural structure to treat the chronic medical condition if said determined HRV parameter exceeds said threshold HRV value.

8. The method of claim 7 wherein said determined HRV parameter is selected from the group consisting of a statistical HRV parameter, a geometric HRV parameter, a spectral HRV parameter, a rhythm pattern HRV parameter, and a nonlinear HRV parameter.

9. The method of claim 8 wherein said statistical HRV parameter is selected from the group consisting of SDNN, SDANN, RMSSD, pNN50;

said spectral parameter is selected from the group consisting of HF power and the ratio of HR to LF power;

said nonlinear parameter is selected from the group consisting of a singular value decomposition, an attractor trajectory, a D2 correlation dimension, a Lyapunov exponent, and a Kolmogorov entropy.

10. A medical device for treating a chronic medical condition in a patient, comprising:

a sensing module for sensing data relating to a time of beat sequence of the patient'"'"'s heart;

a heart beat data processing module to process the data relating to the time of beat sequence;

a heart parameter module adapted to determine at least one heart parameter selected from a heart rate variability (HRV) parameter associated with a parasympathetic function of the patient and a regulatory system parameter indicative of a stress level of the patient'"'"'s regulatory adaptation systems, wherein said heart parameter module is also adapted to determine said at least one heart parameter based upon the processed data relating to the time of beat sequence of the patient'"'"'s heart;

a comparator adapted to compare the at least one heart parameter determined by said heart parameter module with a threshold heart parameter value; and

an electrical signal module adapted to generate and apply an electrical signal to a neural structure to treat the chronic medical condition in the patient based upon the comparison of the determined heart parameter value and the threshold heart parameter value.

11. The medical device of claim 10, further comprising:

a memory unit to store the at least one heart parameter; and

a communications module adapted to communicate an electrical signal indicating when the at least one heart parameter value exceeds said threshold heart parameter value to at least one of a patient or a healthcare provider.

12. The medical device of claim 10, further comprising a lead interface, the lead interface being adapted to provide the electrical signal to a lead capable of being operatively coupled using an electrode, to at least one of 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, or a vagus nerve of the patient.

13. The medical device of claim 10, wherein said heart parameter module is adapted to determine a regulatory system parameter comprising an index of activity of regulatory systems (IARS) associated with the patient.

14. The medical device of claim 13, wherein the regulatory state module is further adapted to determine whether the determined IARS value is greater than a predetermined threshold IARS value.

15. The medical device of claim 10, wherein the chronic medical condition is at least one of a traumatic brain injury;

complications from stroke;

a chronic cardiac disorders;

obesity;

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

multiple sclerosis;

fibromyalgia; and

arthritis.

16. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method of providing a therapy to a patient having a chronic medical condition, the method comprising:

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; and

providing a therapy to the patient in response to a determination that the first IARS value exceeds the first threshold IARS value.

17. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 16, wherein the therapy is selected from the group consisting of:

applying an electrical signal to a neural structure of a patient;

delivering a drug to a patient; and

cooling a neural structure of a patient.

18. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 16, wherein applying the electrical signal to the neural structure of the patient comprises at least one of applying a deep brain stimulation (DBS) signal to a brain structure or applying an electrical signal to a vagus nerve of a patient.

19. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 16, further comprising:

determining a second IARS value for said patient after applying the therapy to the patient;

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

providing a second therapy to the patient in response to a determination that based upon the comparison, the second IARS value exceeds said first threshold IARS value.

20. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 16, further comprising:

determining a second IARS value for said patient after applying the therapy to the patient;

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

discontinuing providing the therapy to the patient in response to a determination that based upon the comparison, the second IARS value is less than or equal to said threshold IARS value.

21. The computer readable program storage device encoded with instructions that, when executed by a computer, performs the method of claim 16, further comprising:

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

providing the second therapy to the patient in response to a determination that based upon the comparison, the second IARS value is greater than said second threshold IARS value.

22. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method of providing a therapy to a patient having a chronic medical condition, the method comprising:

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

determining an HRV parameter indicative of parasympathetic activity from said time of beat sequence;

comparing the determined HRV value to a threshold HRV value; and

providing a therapy to the patient in response to a determination that the HRV value is below the threshold HRV value.

23. A medical system for providing an indication of a level of stress upon a regulatory system of a patient having a chronic medical condition, comprising a medical device comprising:

a sensing module for sensing data relating to a time of beat sequence of the patient'"'"'s heart;

a heart beat data processing module adapted to process the data relating to the time of beat sequence;

a regulatory activity module adapted to determine an index of regulatory activity systems (IARS) value associated with the patient based upon the data relating to the time of beat sequence of the patient'"'"'s heart, wherein the IARS value is indicative of level of stress upon the regulatory system of the patient; and

a communication module adapted to provide the IARS value to at least one of a patient or a healthcare provider; and

wherein the medical device is adapted to provide a treatment to the patient in response to a determination that the IARS value indicates a chronic condition in the patient.

24. The medical system of claim 23, further comprising an HRV module for determining an HRV parameter based upon said time of beat sequence, said HRV parameter also being adapted to compare an HRV parameter value to a threshold HRV parameter value to determine a vagal function of the patient.

25. The medical system of claim 23, wherein the indication of the level of stress upon the regulatory system comprises a level of stress upon the regulatory system at least partially resulting from at least one of traumatic brain injury;

complications from stroke;

chronic cardiac disorders (such as congestive heart failure);

obesity;

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

multiple sclerosis;

fibromyalgia; and

arthritis.

26. The medical system of claim 23, wherein the regulatory activity module is further adapted to:

compare the IARS value to a predetermined threshold IARS value; and

provide a therapy to the patient in response to a determination that based upon the comparing, the IARS value exceeds the threshold IARS value; and

wherein the medical system further comprises at least one of;

a lead and electrode assembly operatively coupled to the medical device, the lead and electrode assembly being adapted to deliver an electrical signal to a neural structure of the patient;

a drug delivery apparatus adapted to deliver a drug to the patient;

or

a cooling apparatus adapted to cool a neural structure of the patient.

27. The medical system of claim 23, wherein the sensing module is adapted to be implanted into the body of the patient, and wherein the medical system further comprises a monitoring module that is external to the body of the patient, the monitoring module is adapted to communicate with the communications module in the medical device.

28. The implantable medical system of claim 23, wherein the sensing module is adapted to be implanted into the body of the patient, and wherein the regulatory activity module is external to the medical device and to the patient'"'"'s s body.