Multi-sensor strategy for heart failure patient management

• US 8,738,119 B2
• Filed: 10/09/2009
• Issued: 05/27/2014
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yi, Stahmann, Jeffrey E., Siejko, Krzysztof Z., Wariar, Ramesh, Thompson, Julie A., Hatlestad, John D., Beck, Kenneth C.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/576,453
• Publication Number:
  US 20100094102A1
• Time in Patent Office: 1,691 Days
• Field of Search: 600/301, 600508-509, 600/515, 607 1- 2, 607/115, 607/116, 607/119
• US Class Current: 600/515
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• 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 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/121 evaluating hearing capacity
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• 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: A61B 7/00 : Instruments for auscultation
• CPC Class Codes: A61B 7/04 : Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An apparatus comprises plurality of sensors and a processor. Each sensor provides a sensor signal that includes physiological information and at least one sensor is implantable. The processor includes a physiological change event detection module that detects a physiological change event from a sensor signal and produces an indication of occurrence of one or more detected physiological change events, and a heart failure (HF) detection module. The HF detection module determines, using a first rule, whether the detected physiological change event is indicative of a change in HF status of a subject, determines whether to override the first rule HF determination using a second rules, and declares whether the change in HF status occurred according to the first and second rules.

Claims

1. An apparatus comprising:

a plurality of sensors, wherein each sensor is configured to provide a separate sensor signal that includes physiological information, and wherein at least one sensor is implantable;

a processor, communicatively coupled to the sensors, wherein the processor includes;

a physiological change event detection module configured to detect a physiological change event from a sensor signal and to produce an indication of occurrence of one or more detected physiological change events; and

a heart failure (HF) detection module configured to;

determine a change in HF status of a subject by applying a first rule HF determination to a plurality of indications from separate sensor signals of whether respective physiological change events occurred, wherein the first rule HF determination includes determining that the detected physiological change events are indicative of the change in HF status when a number of detected physiological change events are a majority of a set of physiological change events that indicate the change in HF status;

determine whether to override the first rule HF determination using a second rule HF determination; and

declare whether the change in HF status occurred according to the first and second rules.

2. The apparatus of claim 1, wherein the first rule includes indicating the change in HF status when a majority of a set of detectable physiological change events is detected.

3. The apparatus of claim 2, wherein the second rule includes overriding a negative first rule HF determination according to a specificity of a detected physiological change event.

4. The apparatus of claim 3, wherein the second rule includes overriding a negative first rule HF determination when a condition for an S3 heart sound is met in a heart sound signal.

5. The apparatus of claim 2, wherein the second rule includes overriding a positive first rule HF determination according to a negative predictive value of a physiological change event.

6. The apparatus of claim 5, wherein the second rule includes overriding a positive first rule HF determination when a condition in a physiologic response to patient activity is met.

7. The apparatus of claim 2, wherein the HF detection module weights the second rule HF determination greater than the first rule HF determination.

8. The apparatus of claim 1,

wherein the physiological change event detection module is configured to weight the detected physiological change event according to the sensor signal, and

wherein the HF detection module is configured to:

determine a likelihood that the change in HF status occurred using the weight of the physiological change event; and

provide an alert based on the declared HF event, wherein the alert includes an indication of the likelihood that the change in HF status occurred.

9. The apparatus of claim 8, wherein the HF detection module is configured to determine a level of urgency of the alert according to the first and second rules.

10. The apparatus of claim 1, wherein the plurality of sensors includes at least one of:

an implantable heart sound sensor;

an implantable impedance sensor;

an implantable activity sensor;

an implantable respiration sensor;

an implantable blood pressure sensor;

an implantable electrocardiogram sensor;

an implantable oxygen saturation sensor;

an implantable blood flow sensor;

an implantable temperature sensor; and

an implantable intra-thoracic total impedance (ITTI) sensor.

11. The apparatus of claim 1, including:

an implantable device comprising;

at least one of the sensors;

a sampling circuit, communicatively coupled to the implantable sensors, configured to provide a sampled sensor signal; and

a first communication circuit, communicatively coupled to the sampling circuit, configured to communicate the sampled sensor signal to a second device; and

an external device comprising;

a second communication circuit configured to communicate with the implantable device; and

the processor, wherein the processor is communicatively coupled to the second communication circuit, and wherein the physiological change event detection module is configured to detect the physiological change event from a sensor signal including at least one sampled sensor signal communicated from the implantable device.

12. A method comprising:

sensing a plurality of separate physiologic sensor signals using a plurality of sensors of a medical device, wherein each sensor signal includes physiological information, and wherein at least one sensor is implantable;

detecting which physiological change events, if any, of a set of specified physiological change events occurred using the sensor signals;

determining a change in heart failure (HF) status of a subject using a first rule HF determination applied to a plurality of indications from separate sensor signals of whether respective physiological change events occurred, wherein the first rule determines that the detected physiological change events are indicative of the change in HF status when a number of detected physiological change events are a majority of a set of physiological change events that indicate the change in HF status and are detectable by the medical device;

determining whether to override the first rule HF determination using a second rule HF determination; and

declaring whether the change in HF status occurred according to the first and second rules.

13. The method of claim 12, wherein determining whether to override the first rule HF determination using a second rule includes overriding a negative first rule HF determination according to a specificity of a detected physiological change event.

14. The method of claim 13, wherein determining whether to override the first rule HF determination using a second rule includes overriding the negative first rule HF determination when a condition for an S3 heart sound is met in a heart sound signal.

15. The method of claim 12, wherein determining whether to override the first rule HF determination using a second rule includes overriding a positive first rule HF determination according to a negative predictive value of a detected physiological change event.

16. The method of claim 15, wherein determining whether to override the first rule HF determination using a second rule includes overriding a positive first rule HF determination when a condition in a physiologic response to patient activity is met.

17. The method of claim 12, wherein determining whether to override the first rule HF determination using a second rule includes weighting the second rule HF determination greater than the first rule HF determination.

18. The method of claim 12, wherein determining which physiological change events occurred includes weighting the detected physiological change event according to the sensor signal, and wherein the method includes providing an alert based on the declared change in HF status, wherein the alert includes an indication of a likelihood that the change in HF status occurred.

19. The method of claim 18, including determining a level of urgency of the alert according to the first and second rules.

20. The method of claim 12, wherein sensing a plurality of physiological sensor signals includes sensing at least one of:

an implantable heart sound sensor;

an implantable impedance sensor;

an implantable activity sensor;

an implantable respiration sensor;

an implantable blood pressure sensor;

an implantable electrocardiogram sensor;

an implantable oxygen saturation sensor;

an implantable blood flow sensor;

an implantable temperature sensor; and

an implantable intra-thoracic total impedance (ITTI) sensor.

21. The method of claim 12, including:

sampling at least one physiological sensor signal using an implantable device;

communicating the sampled physiological sensor signal from the implantable device to an external device; and

using the external device to detect a physiological change event from the sampled signal, determine whether a detected event is indicative of a change in HF status, and declare whether the change in HF status occurred according to the first and second rules.