Multi-sensor strategy for heart failure patient management

Patent metadata

Field	Value
Publication number	US-2016000338-A1
Application number	US-201514857161-A
Country	US
Kind code	A1
Filing date	Sep 17, 2015
Priority date	Oct 10, 2008
Publication date	Jan 7, 2016
Grant date	—

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.

First claim

1 . A system comprising:
a plurality of sensors, each sensor configured to provide a sensor signal that includes physiological information; 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 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: determine whether to override the first rule HF determination using a second rule; and generate an indication of whether the change in HF status occurred according to the first and second rules.

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

3 . The system 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; and overriding a positive first rule HF determination according to a negative predictive value of a physiological change event.

4 . The system 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.

5 . The system of claim 1 , wherein the plurality of sensors are included in a first device and the processor is included in a second device

6 . The system of claim 1 , wherein the plurality of sensors are included in a first implantable device and the processor is included in an external device.

7 . The system of claim 1 , wherein the processor is included in an implantable medical device.

8 . The system of claim 1 , wherein the plurality of sensors includes at least one of: an impedance sensor, a respiration sensor, and an intra-thoracic total impedance (ITTI) sensor.

9 . The system of claim 1 , wherein the plurality of sensors includes at least one of an activity sensor and an electrocardiogram sensor.

10 . The system of claim 1 , wherein the plurality of sensors includes an implantable heart sound sensor.

11 . The system of claim 1 , wherein the plurality of sensors includes at least one of: a blood pressure sensor; an oxygen saturation sensor; a blood flow sensor; and a temperature sensor.

12 . The system of claim 1 , 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.

13 . The system of claim 1 , 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.

14 . The system of claim 1 , wherein the physiological change event detection module is configured to: compare a sensor signal from a sensor of the plurality of sensors to a specified threshold; and assign one indication of a plurality of indications of occurrence of a physiological change event to the sensor signal according to the comparison; and wherein the HF detection module is configured to: accumulate indications assigned to the sensors signals provided by the plurality of sensors; and determine whether the detected physiological change events are indicative of a change in HF status using the accumulated indications.

15 . The system of claim 14 , wherein the HF detection module is configured to assign a weight to the indication of a change in HF status using the accumulated indications assigned to the sensor signals.

16 . The system of claim 14 , wherein the physiological change event detection module is configured to assign one of three or more indications of a physiological change event to the sensor signal according to a comparison to a plurality of specified thresholds.

17 . The system of claim 14 , wherein the HF detection module is configured to override indications assigned to a first set of sensor signals according to an indication assigned to a sensor signal different from the first set of sensor signals.

18 . A method of controlling operation of a medical device system, the 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; 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; determining whether to override the first rule HF determination using a second device-based rule; 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.

19 . The method of claim 18 , 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.

20 . The method of claim 18 , 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.

Assignees

• Cardiac Pacemakers Inc

Inventors

• Zhang Yi
• Stahmann Jeffrey E
• Siejko Krzysztof Z
• Wariar Ramesh
• Thompson Julie A
• Hatlestad John D
• Beck Kenneth C

Classifications

• A61B7/04

  Electric stethoscopes · CPC title

• A61B5/121

  evaluating hearing capacity · CPC title

• A61B5/7275

  Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor · CPC title

• A61B5/0205

  Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition · CPC title

• A61B5/0816

  Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00) · CPC title