Monitoring of chronobiological rhythms for disease and drug management using one or more implantable device

• US 8,005,540 B2
• Filed: 07/14/2010
• Issued: 08/23/2011
• Est. Priority Date: 10/31/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Dalal, Yousufali, Patangay, Abhilash, Carlson, Gerrard M., Zhang, Yi, Siejko, Krzysztof Z., Hatlestad, John D., Lee, Kent, Brockway, Marina V., Kuenzler, Richard O., Haro, Carlos
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US12/836,441
• Publication Number:
  US 20100280564A1
• Time in Patent Office: 405 Days
• Field of Search: 607 1- 5
• US Class Current: 607/3
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The health state of a subject is automatically evaluated or predicted using at least one implantable device. In varying examples, the health state is determined by sensing or receiving information about at least one physiological process having a circadian rhythm whose presence, absence, or baseline change is associated with impending disease, and comparing such rhythm to baseline circadian rhythm prediction criteria. Other chronobiological rhythms beside circadian may also be used. The baseline prediction criteria may be derived using one or more past physiological process observation of the subject or population of subjects in a non-disease health state. The prediction processing may be performed by the at least one implantable device or by an external device in communication with the implantable device. Systems and methods for invoking a therapy in response to the health state, such as to prevent or minimize the consequences of predicted impending heart failure, are also discussed.

Claims

1. A method comprising:

sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;

comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria; and

at least one of predicting, detecting, or identifying an occurrence of disease using the comparison.

2. The method of claim 1, wherein predicting the occurrence of disease includes predicting an occurrence of impending disease occurring during a specified prediction time period.

3. The method of claim 1, wherein sensing or receiving the information about the at least one physiological process includes sensing or receiving at least one of body temperature, heart rate, heart rate variability, respiration rate, respiration rate variability, minute ventilation, tidal volume, activity, blood pressure, posture, sleep pattern, thoracic impedance, or at least one heart sound.

4. The method of claim 1, further comprising providing an associated collection time to the chronobiological rhythm of the at least one physiological process.

5. The method of claim 1, further comprising sensing or receiving information about at least one arrhythmia incidence;

and

wherein predicting the occurrence of disease includes using a time of day of the arrhythmia incidence.

6. A method comprising:

sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;

comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria; and

at least one of predicting, detecting, or identifying an occurrence of disease using the comparison, wherein predicting the occurrence of disease is computed using one or more stored weighting factor, each weighting factor corresponding to a chronobiological rhythm of a different one of the at least one physiological process.

7. The method of claim 6, further comprising adjusting or initiating a therapy using the predicted, detected, or identified occurrence of disease.

8. The method of claim 7, wherein adjusting or initiating the therapy includes determining a drug delivery time using the chronobiological rhythm of the at least one physiological process.

9. The method of claim 7, wherein adjusting or initiating the therapy includes recovering the chronobiological rhythm of the at least one physiological process using one or both of drug delivery or neurostimulation.

10. The method of claim 7, further comprising monitoring the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process.

11. A method comprising:

sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;

comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria; and

applying a therapy.

12. The method of claim 11, wherein applying the therapy includes using the comparison of the chronobiological rhythm and the one or more chronobiological rhythm prediction criteria.

14. The method of claim 11, further comprising monitoring the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process.

15. The method of claim 11, wherein sensing or receiving the information about the at least one physiological process includes sensing or receiving at least one of body temperature, heart rate, heart rate variability, respiration rate, respiration rate variability, minute ventilation, tidal volume, activity, blood pressure, posture, sleep pattern, thoracic impedance, or at least one heart sound.

16. The method of claim 11, further comprising providing an associated collection time to the chronobiological rhythm of the at least one physiological process.

13. A method comprising:

sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;

comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria; and

applying a therapy, wherein applying the therapy includes using a subject-responsive drug delivery time derived using one or more past post-therapy chronobiological rhythm observations from a subject in a similar pre-therapy disease-state.

17. A method comprising:

sensing or receiving at an implantable device, information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease;

comparing the chronobiological rhythm of the at least one physiological process to one or more chronobiological rhythm prediction criteria; and

applying a therapy, further comprising predicting the occurrence of the disease by computing probability using one or more stored weighting factor, each weighting factor corresponding to a chronobiological rhythm of a different one of the at least one physiological process.

18. A method comprising:

applying a therapy to a subject; and

monitoring an efficacy of the therapy, including sensing or receiving at an implantable device a post-therapy chronobiological rhythm associated with at least one of body temperature, heart rate, heart rate variability, respiration rate, respiration rate variability, minute ventilation, tidal volume, activity, blood pressure, posture, sleep pattern, thoracic impedance, or at least one heart sound;

wherein monitoring the efficacy of the therapy includes comparing the post-therapy chronobiological rhythm to one or more chronobiological rhythm prediction criteria.

19. The method of claim 18, wherein applying the therapy includes delivering one or both of drug or electrical stimulation therapy to the subject.

20. The method of claim 18, further comprising titrating the therapy using the monitored efficacy of the therapy.