MULTI-SENSOR STRATEGY FOR HEART FAILURE PATIENT MANAGEMENT

• US 20170156604A1
• Filed: 02/23/2017
• Published: 06/08/2017
• 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., Wariar, Ramesh, Siejko, Krzysztof Z., Beck, Kenneth C., Hatlestad, John D., Thompson, Julie A.
• Granted Patent: US 10,456,049 B2
• Time in Patent Office: Days
• 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 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. (canceled)

2. A method of controlling operation of a medical device system, the method comprising:

sensing a plurality of separate physiologic sensor signals produced using a plurality of sensors, wherein each sensor signal includes physiological information;

detecting a physiological change event from a sensor signal;

determining whether the detected physiological change events are indicative of a change in heart failure (HF) status using a first device-based rule applied to the physiological change events;

determining whether to rule out a positive first rule HF determination using a second device-based rule applied to at least one of the physiological change events;

generating an indication of whether the change in HF status occurred according to the first and second rules; and

presenting a change to patient therapy according to the generated indication.

3. The method of claim 2, including:

sampling the plurality of separate physiologic sensor signals using a first medical device;

communicating the sampled physiological sensor signals from the first medical device to a second separate medical device; and

using the second medical device, detecting the physiological change event from the sampled physiological sensor signals and generating the indication of whether the change in HF status occurred.

4. The method of claim 2, comparing a physiological sensor signal of the plurality of separate physiologic sensor signals to a specified threshold;

assigning one indication of a plurality of indications of occurrence of a physiological change event to the physiological sensor signal according to the comparison; and

accumulating indications assigned to the plurality of separate physiologic sensor signals; and

determining whether the detected physiological change events are indicative of a change in HF status using the accumulated indications.

5. The method of claim 2, wherein the determining whether the detected physiological change events are indicative of a change in HF status using a first device-based rule includes determining whether the detected physiological change events are indicative of a change in HF status when a majority of a set of detectable physiological change events is detected.

6. The method of claim 5, wherein the determining whether to rule out a positive first rule HF determination using a second device-based rule includes overriding a negative first rule HF determination according to a specificity of a detected physiological change event;

and overriding the positive first rule HF determination according to a negative predictive value of a physiological change event.

7. The method of claim 2, wherein the determining whether the detected physiological change events are indicative of a change in HF status using a first device-based rule includes determining whether the detected physiological change events are indicative of a change in HF using an individual assessment of HF using the physiological information provided by the sensor signal of each of the sensors.

8. The method of claim 2, including producing a binary indication of occurrence a physiological change event using a sensor signal from a sensor of the plurality of sensors, and applying the first rule and the second rule to binary indications produced by the physiological change event detection module.

9. The method of claim 2, including producing a ternary indication of occurrence a physiological change event using a sensor signal from a sensor of the plurality of sensors, and applying the first rule and the second rule to ternary indications produced by the physiological change event detection module.

10. The method of claim 2, wherein sensing a plurality of separate physiologic sensor signals includes sensing one or more of an activity signal and an electrocardiogram signal.

11. The method of claim 2, wherein sensing a plurality of separate physiologic sensor signals includes sensing a heart sound signal using an implantable heart sound sensor.

12. The method of claim 2, sensing a plurality of separate physiologic sensor signals using a plurality of sensors includes sensing a physiologic sensor signal using one or more of:

a blood pressure sensor;

an oxygen saturation sensor;

a blood flow sensor; and

a temperature sensor.

13. The method of claim 2, wherein sensing a plurality of separate physiologic sensor signals includes sensing using one or more of an impedance signal and a respiration signal.

14. A medical device system comprising:

a processor for receiving a plurality of sensor signals, wherein the processor includes;

a physiological change event detection module configured to;

detect a physiological change event of a subject from a sensor signal; and

produce an indication of occurrence of one or more physiological change events; and

a heart failure (HF) detection module configured to;

determine whether the detected physiological change events are indicative of a change in HF status using a first rule applied to the physiological change events;

determine whether to rule out a positive first rule HF determination using a second rule applied to at least one of the physiological change events; and

generate an indication of whether the change in HF status occurred according to the first and second rules.

15. The medical device system of claim 14, wherein the first rule includes indicating a change in HF status when a majority of a set of detectable physiological change events is detected.

16. The medical device system of claim 15, wherein the second rule includes:

overriding a negative first rule HF determination according to a specificity of a detected physiological change event; and

overriding the positive first rule HF determination according to a negative predictive value of a physiological change event.

17. The medical device system of claim 14, wherein the first rule includes an individual assessment of HF using the physiological information provided by the sensor signal of each of the sensors.

18. The medical device system of claim 14, wherein the physiological change event detection module is configured to produce a binary indication of occurrence a physiological change event using a sensor signal from a sensor of the plurality of sensors, and wherein HF detection module is configured to apply the first rule and the second rule to binary indications produced by the physiological change event detection module.

19. The medical device system of claim 14, wherein the physiological change event detection module is configured to produce a ternary indication of occurrence a physiological change event using a sensor signal from a sensor of the plurality of sensors, and wherein HF detection module is configured to apply the first rule and the second rule to ternary indications produced by the physiological change event detection module.

20. The medical device system of claim 14, including a plurality of sensors that provides the plurality of sensor signals to the processor, each sensor configured to provide a sensor signal that includes physiological information.

21. The medical device system of claim 20, wherein the plurality of sensors includes at least one of an activity sensor and an electrocardiogram sensor.