Apparatus and method for chronically monitoring heart sounds for deriving estimated blood pressure

• US 20040167417A1
• Filed: 02/26/2003
• Published: 08/26/2004
• Est. Priority Date: 02/26/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lee, Brian B., Schulhauser, Randal C., Son, Mark, Stefanov, Gary, Haupt, Nicole M., Tracy, Jon S., Rieder, Eric M.
• Granted Patent: US 6,869,404 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise

Abstract

A minimally invasive, implantable heart sound and ECG monitor and associated method for deriving blood pressure from heart sound data. The device is equipped with an acoustical sensor for detecting first and second heart sounds which are sampled and stored during sensing windows following R-wave and T-wave detections, respectively. ECG and heart sound data are stored in a continuous, looping memory, and segments of data are stored in long-term memory upon an automatic or manual data storage triggering event. Estimated blood pressure is calculated based on custom spectral analysis and processing of the first and second heart sounds. A calibration method includes measuring a patient'"'"'s blood pressure using a standard clinical method and performing regression analysis on multiple spectral variables to identify a set of best fit weighted equations for predicting blood pressure. Concurrent ECG and estimated blood pressure may be displayed for review by a physician.

Claims

1. A method for deriving an estimated blood pressure of a patient, comprising the steps of:

sensing first heart sound signals;

generating blood pressure estimation parameters in response to the first heart sound signals;

sensing second heart sound signals and cardiac depolarizations corresponding to the second heart sound signals; and

determining an estimated blood pressure in response to the second heart sound signals, the cardiac depolarizations corresponding to the second heart sound signals, and the generated blood pressure estimation parameters.

2. The method of claim 1, wherein the step of determining an estimated blood pressure further comprises performing spectral analysis of the second heart sound signals.

3. The method of claim 1, further comprising repeating the steps of sensing first heart sound signals and generating blood pressure estimation parameters prior to the step of determining an estimated blood pressure.

4. The method of claim 1, further comprising uplinking data corresponding to the second heart sound signals and the cardiac depolarizations corresponding to the second heart sound signals to an external device, wherein the step of determining an estimated blood pressure is performed at the external device.

5. The method of claim 1, further comprising the step of simultaneously displaying the determined estimated blood pressure and corresponding cardiac depolarizations.

6. The method of claim 1, wherein the step of sensing second heart sound signals further comprises generating operating parameters corresponding to acquisition, processing and storing of the subsequently sensed cardiac signals.

7. The method of claim 1, wherein the step of sensing second heart sound signals further comprises the steps of:

generating a first heart sound sensing time period and a second heart sound sensing time period;

detecting an R-wave and a T-wave;

sensing a third heart sound signal within the first heart sound sensing time period in response to the detected R-wave;

sensing a fourth heart sound signal within the second heart sound sensing time period in response to the detected T-wave;

detecting a trigger event; and

storing data corresponding to the third heart sound signal and the fourth heart sound signal in response to the detected trigger event.

8. The method of claim 7, wherein the data corresponding to the third heart sound signal and the fourth heart sound signal is stored in one of long-term memory and short-term memory.

9. The method of claim 1, wherein the step of generating blood pressure estimation parameters comprises:

determining the patient'"'"'s blood pressure using an external measuring device;

sampling heart sound data corresponding to the determined blood pressure;

performing spectral analysis of the sampled heart sound data;

determining spectral variables;

determining a running average for each of the variables from a predetermined number of cardiac cycles;

perform a best fit analysis to generate a best fit curve for the determined blood pressure as a function of spectral variables; and

determining a weighted predicted blood pressure value in response to the best fit analysis.

10. The method of claim 1, wherein the step of determining an estimated blood pressure comprises:

performing spectral analysis of the second heart sounds;

determining rolling average spectral variables;

calculating a weighted blood pressure for each of the variables; and

calculating the estimated blood pressure in response to the calculated weighted blood pressure.

11. An implantable medical device system for deriving an estimated blood pressure of a patient, comprising:

a first sensing portion sensing cardiac depolarizations;

a second sensing portion sensing heart sounds and generating corresponding heart sound signals including first heart sound signals and second sound heart signals;

a storage device;

a control circuit receiving data from the first sensing portion and the second sensing portion and controlling storage of the sensed cardiac depolarizations and the heart sound signals in the storage device;

an external device receiving the sensed cardiac depolarizations and the heart sound signals from the storage device, generating blood pressure estimation parameters in response to the first heart sound signals, and determining an estimated blood pressure in response to the second heart sound signals, the cardiac depolarizations corresponding to the second heart sound signals, and the generated blood pressure estimation parameters.

12. The system of claim 11, wherein the external device performs spectral analysis of the second heart sound signals.

13. The system of claim 11, wherein the external device re-generates the blood pressure estimation parameters prior to determining the estimated blood pressure.

14. The system of claim 11, further comprising a display device positioned at the external device simultaneously displaying the determined estimated blood pressure and corresponding cardiac depolarizations.

15. The system of claim 11, wherein the external device monitors the second heart sound signals and the cardiac depolarizations corresponding to the second heart sound signals, and generates resulting operating parameters corresponding to acquisition, processing and storing of the subsequently sensed cardiac signals.

16. The system of claim 11, further comprising an event trigger device transmitting a trigger signal to the control circuit and the external device, wherein the cardiac depolarizations sensed by the first sensing device include an R-wave and a T-wave, and wherein the external device generates a first heart sound sensing time period and a second heart sound sensing time period, the second sensing portion senses a third heart sound signal within the first heart sound sensing time period in response to the sensed R-wave and a fourth heart sound signal within the second heart sound sensing time period in response to the sensed T-wave, and the control circuit stores data corresponding to the third heart sound signal and the fourth heart sound signal in response to the trigger signal.

17. The system of claim 16, wherein the storage device includes long-term memory and short-term memory, and the data corresponding to the third heart sound signal and the fourth heart sound signal is stored in one of the long-term memory and the short-term memory in response to the trigger signal.

18. The system of claim 11, further comprising an external measuring device to generate a measurement of blood pressure externally from the patient, wherein the external device receives the external blood pressure measurement from the external measuring device, samples heart sound data corresponding to the external blood pressure measurement, performs spectral analysis of the sampled heart sound data, determines spectral variables and a running average for each of the variables from a predetermined number of cardiac cycles, performs a best fit analysis to generate a best fit curve for the determined blood pressure as a function of spectral variables, and determines a weighted predicted blood pressure value in response to the best fit analysis.

19. The system of claim 11, wherein the external device perfors spectral analysis of the second heart sounds, determines rolling average spectral variables, calculates a weighted blood pressure for each of the variables, and determines the estimated blood pressure in response to the calculated weighted blood pressure.

20. An implantable medical device system for deriving an estimated blood pressure of a patient, comprising:

means for sensing first heart sound signals;

means for generating blood pressure estimation parameters in response to the first heart sound signals;

means for sensing second heart sound signals and cardiac depolarizations corresponding to the second heart sound signals; and

means for determining an estimated blood pressure in response to the second heart sound signals, the cardiac depolarizations corresponding to the second heart sound signals, and the generated blood pressure estimation parameters.