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

• US 8,401,636 B2
• Filed: 08/15/2011
• Issued: 03/19/2013
• 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: Zhang, Yi, Hatlestad, John D., Carlson, Gerrard M., Dalal, Yousufali, Brockway, Marina V., Lee, Kent, Kuenzler, Richard O., Haro, Carlos, Siejko, Krzysztof Z., Patangay, Abhilash
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/209,938
• Publication Number:
  US 20110301530A1
• Time in Patent Office: 582 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 system comprising:

a prediction criteria module, adapted to store information about one or more chronobiological rhythm prediction criteria;

a physiological information collection device, adapted to sense or receive information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease state;

an impending disease state prediction module, coupled to the prediction criteria module to receive the one or more chronobiological rhythm prediction criteria and coupled to the physiological information collection device to receive the chronobiological rhythm of the at least one physiological process, the impending disease state prediction module being adapted to predict an occurrence of impending disease using the one or more chronobiological rhythm prediction criteria and the chronobiological rhythm of the at least one physiological process;

a therapy control module adapted to adjust or initiate a therapy using the predicted occurrence of impending disease; and

a neural stimulation circuit, coupled to the therapy control module to receive one or more neurostimulation delivery instruction.

2. The system of claim 1, wherein at least one of the prediction criteria module, the physiological information collection device, or the impending disease state prediction module include an implantable portion.

3. The system of claim 1, wherein the predicted occurrence of impending disease is computed using one or more stored weighting factors, each weighting factor corresponding to a chronobiological rhythm of a different one of the at least one physiological processes.

4. The system of claim 1, wherein the impending disease state prediction module is adapted to predict that an occurrence of impending disease will occur during a specified prediction time period after the prediction.

5. The system of claim 1, wherein the information about the at least one physiological process is sensed or received, at least in part, using an implantable device or sensor.

6. The system of claim 1, wherein the at least one physiological process includes one or more 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.

7. The system of claim 6, further comprising a timing circuit coupled to the physiological information collection device to provide an associated collection time to the chronobiological rhythm of the at least one physiological process;

and

wherein the associated collection time is used by the impending disease state prediction module to predict the occurrence of impending disease.

8. The system of claim 1, further comprising an arrhythmia detector adapted to sense or receive information about an arrhythmia incidence;

and

wherein a time of the arrhythmia incidence is used by the impending disease state prediction module to predict the occurrence of impending disease.

9. The system of claim 1, wherein the chronobiological rhythm prediction criteria are derived using one or more past physiological process observation from a subject in a non-disease state.

10. The system of claim 1, further comprising an implantable drug pump, coupled to the therapy control module to receive one or more drug delivery instruction.

11. The system of claim 1, further comprising at least one of a ventricular or atrial stimulation circuit, coupled to the therapy control module to receive one or more cardiac stimulation delivery instruction.

12. The system of claim 1, wherein the therapy control module is adapted to monitor the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process.

13. The system of claim 1, wherein the therapy control module is programmed to titrate the delivery of neurostimulation.

14. The system of claim 13, wherein the therapy control module is programmed to titrate the delivery of neurostimulation by scheduling such delivery or adjusting the level of the neurostimulation in an open- or closed-loop manner that takes into consideration the effects of the chronobiological rhythm signals sensed or received.

15. The system of claim 1, wherein the neural stimulation circuit includes electrodes.

16. A system comprising:

a prediction criteria module, adapted to store information about one or more chronobiological rhythm prediction criteria;

a physiological information collection device, adapted to sense or receive information about at least one physiological process having a chronobiological rhythm whose presence, absence, or change is statistically associated with a disease state;

an impending disease state prediction module, coupled to the prediction criteria module to receive the one or more chronobiological rhythm prediction criteria and coupled to the physiological information collection device to receive the chronobiological rhythm of the at least one physiological process, the impending disease state prediction module being adapted to predict an occurrence of impending disease using the one or more chronobiological rhythm prediction criteria and the chronobiological rhythm of the at least one physiological process, wherein the predicted occurrence of impending disease is computed using one or more stored weighting factors, each weighting factor corresponding to a chronobiological rhythm of a different one of the at least one physiological processes;

a therapy control module adapted to adjust or initiate a therapy using the predicted occurrence of impending disease; and

a neural stimulation circuit, coupled to the therapy control module to receive one or more neurostimulation delivery instruction.

17. The system of claim 16, wherein the impending disease state prediction module is adapted to predict that an occurrence of impending disease will occur during a specified prediction time period after the prediction.

18. The system of claim 16, wherein the therapy control module is adapted to monitor the efficacy of the therapy using a post-therapy chronobiological rhythm of the at least one physiological process.

19. The system of claim 16, wherein the therapy control module is programmed to titrate the delivery of neurostimulation.

20. The system of claim 19, wherein the therapy control module is programmed to titrate the delivery of neurostimulation by scheduling such delivery or adjusting the level of the neurostimulation in an open- or closed-loop manner that takes into consideration the effects of the chronobiological rhythm signals sensed or received.