IP Library Granted Patent US 9,901,266
Granted Patent B2
US 9,901,266 · App. 14/738,022 · Granted Feb 27, 2018

Apparatus and method for personalized cardiac signal processing

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Quick Facts
Patent No.
US 9,901,266
App. No.
14/738,022
Granted
Feb 27, 2018
Kind
B2
Abstract

A medical device includes a housing configured for implantation within a body of a patient. Detection circuitry is disposed in the housing and coupled to an electrode arrangement. The detection circuitry is configured to sense a cardiac electrical signal from the patient. A processor is coupled to the detection circuitry and configured to compute a first measure of heart rate variability (HRV) using the cardiac electrical signal, and compute a second measure of HRV using the cardiac electrical signal, the second measure of HRV differing from the first measure of HRV. The processor is also configured to produce an index of patient status derived from a ratio of the first and second measures of HRV, such that the index is a normalized HRV metric personalized to the patient. The processor or a remote system can use the index to assess acute and chronic changes in patient status.

Claims (63)

1. A method implemented by an implantable medical device, comprising:

detecting a cardiac electrical signal from a patient;

computing a first measure of heart rate variability (HRV) using the cardiac electrical signal, the first measure of HRV comprising one of a daytime measure and a nighttime measure of the patient's HRV;

computing a second measure of HRV using the cardiac electrical signal, the second measure of HRV comprising the other of the daytime measure and the nighttime measure of the patient's HRV;

producing an index of patient status derived from a ratio of the first and second measures of HRV, such that the index is a normalized HRV metric personalized to the patient; and

diagnosing a change in the patient's status using the index;

wherein each of detecting, computing, producing, and diagnosing is performed by the implantable medical device.

2. The method of claim 1 , wherein each of the first and second HRV measures is a different one of:

a baseline measure of the patient's HRV;

a peak measure of the patient's HRV;

a maximum measure of the patient's HRV;

a minimum measure of the patient's HRV;

a measure of the patient's HRV during a period of high patient activity; and

a measure of the patient's HRV during a period of low patient activity.

3. The method of claim 1 , wherein:

the first HRV measure is an instantaneous measure of the patient's HRV at a first prescribed time or during a physiologic episode; and

the second HRV measure is one of a measure of the patient's HRV at a second prescribed time differing from the first prescribed time, a baseline of the patient's HRV, and a measure of the patient's HRV during a physiologic episode.

4. The method of claim 3 , wherein the physiologic episode comprises aberrant cardiac activity or a physiologic response to a drug administered to the patient.

5. The method of claim 1 , wherein diagnosing the change in the patient's status comprises determining, by the implantable medical device, patient compliance to a medication regimen using a deviation of the index from a threshold indicative of lapse of medication effectiveness, wherein the threshold is a predetermined threshold.

6. The method of claim 1 , wherein diagnosing the change in the patient's status comprises determining, by the implantable medical device, patient compliance to a medication regimen using a deviation of the index from a threshold indicative of lapse of medication effectiveness, wherein the threshold is an adaptive threshold.

7. The method of claim 1 , further comprising trending, by the implantable medical device, the index and generating chronic assessment data of the patient's status.

8. The method of claim 1 , wherein diagnosing the change in the patient's status comprises diagnosing further comprising detecting, by the implantable medical device, atrial fibrillation using the index, wherein the ratio of the patient's first and second HRV measures deviates from a predetermined threshold indicative of the presence of atrial fibrillation for a specified heart rate.

9. The method of claim 1 , wherein diagnosing the change in the patient's status comprises diagnosing, by the implantable medical device, atrial fibrillation using the index, wherein the ratio of the patient's first and second HRV measures deviates from an adaptive threshold indicative of the presence of atrial fibrillation for a specified heart rate.

10. The method of claim 1 , wherein the index defines a primary index and the method further comprises:

computing a third measure of heart rate variability (HRV) using the cardiac electrical signal;

computing a fourth measure of HRV using the cardiac electrical signal, the fourth measure of HRV differing from the third measure of HRV;

producing a secondary index of patient status derived from a ratio of the third and fourth measures of HRV reflective of a secondary patient situation, condition or time period; and

producing a tertiary index of patient status derived from a ratio of the primary and secondary indices.

11. The method of claim 1 , wherein the index defines a first index and the method further comprises:

computing a third measure of heart rate variability (HRV) using the cardiac electrical signal;

computing a fourth measure of HRV using the cardiac electrical signal, the fourth measure of HRV differing from the third measure of HRV; and

producing a second index of patient status derived from a ratio of the third and fourth measures of HRV, such that the second index is a normalized HRV metric personalized to the patient;

wherein diagnosing the change in the patient's status comprises diagnosing, by the implantable medical device, atrial fibrillation using a comparison of the first and second indices, wherein agreement of the first and second indices serves as a confirmatory result and a lack of agreement of the first and second indices serves as an indicator prompting additional analysis for atrial fibrillation detection.

12. A medical device, comprising:

a housing configured for implantation within a body of a patient;

detection circuitry disposed in the housing and coupled to an electrode arrangement, the detection circuitry configured to sense a cardiac electrical signal from the patient; and

a processor disposed in the housing and coupled to the detection circuitry, the processor configured to:

compute a first measure of heart rate variability (HRV) using the cardiac electrical signal, the first measure of HRV comprising one of a daytime measure and a nighttime measure of the patient's HRV;

compute a second measure of HRV using the cardiac electrical signal, the second measure comprising the other of the daytime measure and nighttime measure of the patient's HRV;

produce an index of patient status derived from a ratio of the first and second measures of HRV, such that the index is a normalized HRV metric personalized to the patient; and

diagnose a change in the patient's status using the index.

13. The device of claim 12 , wherein each of the first and second HRV measures is a different one of:

a baseline measure of the patient's HRV;

a peak measure of the patient's HRV;

a maximum measure of the patient's HRV;

a minimum measure of the patient's HRV

a measure of the patient's HRV during a period of high patient activity; and

a measure of the patient's HRV during a period of low patient activity.

14. The device of claim 12 , wherein the processor is configured to diagnose patient compliance to a medication regimen using a deviation of the index from a threshold indicative of lapse of medication effectiveness, wherein the threshold is a predetermined threshold.

15. The device of claim 12 , wherein the processor is configured to diagnose patient compliance to a medication regimen using a deviation of the index from a threshold indicative of lapse of medication effectiveness, wherein the threshold is an adaptive threshold.

16. The device of claim 12 , wherein the processor is further configured to trend the index and generate chronic assessment data of the patient's status.

17. The device of claim 12 , wherein the processor is configured to diagnose atrial fibrillation using the index, wherein the ratio of the patient's first and second HRV measures deviates from a predetermined threshold indicative of the presence of atrial fibrillation for a specified heart rate.

18. The device of claim 12 , wherein the processor is configured to diagnose atrial fibrillation using the index, wherein the ratio of the patient's first and second HRV measures deviates from an adaptive threshold indicative of the presence of atrial fibrillation for a specified heart rate.

19. The device of claim 12 , wherein the index defines a primary index and the processor is further configured to:

compute a third measure of heart rate variability (HRV) using the cardiac electrical signal;

compute a fourth measure of HRV using the cardiac electrical signal, the fourth measure of HRV differing from the third measure of HRV;

produce a secondary index of patient status derived from a ratio of the third and fourth measures of HRV reflective of a secondary patient situation, condition or time period; and

produce a tertiary index of patient status derived from a ratio of the primary and secondary indices.

20. The device of claim 12 , wherein the index defines a first index and the processor is further configured to:

compute a third measure of heart rate variability (HRV) using the cardiac electrical signal;

compute a fourth measure of HRV using the cardiac electrical signal, the fourth measure of HRV differing from the third measure of HRV;

produce a second index of patient status derived from a ratio of the third and fourth measures of HRV, such that the second index is a normalized HRV metric personalized to the patient; and

diagnose atrial fibrillation using a comparison of the first and second indices, wherein agreement of the first and second indices serves as a confirmatory result and a lack of agreement of the first and second indices serves as an indicator prompting additional analysis for atrial fibrillation detection.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Oct 12, 2022
From: MANUFACTURERS AND TRADERS TRUST COMPANY (AS ADMINISTRATIVE AGENT)
To: GREATBATCH, INC.; GREATBATCH LTD.; ELECTROCHEM SOLUTIONS, INC.; NEURONEXUS TECHNOLOGIES, INC.; GREATBATCH-GLOBE TOOL, INC.; PRECIMED INC.; MICRO POWER ELECTRONICS, INC.
Reel/Frame 061659/0858 →
RELEASE OF SECURITY INTEREST Recorded Jan 6, 2022
From: MANUFACTURERS AND TRADERS TRUST COMPANY (AS ADMINISTRATIVE AGENT)
To: GREATBATCH, INC.; GREATBATCH LTD.; ELECTROCHEM SOLUTIONS, INC.; NEURONEXUS TECHNOLOGIES, INC.; GREATBATCH-GLOBE TOOL, INC.; PRECIMED INC.; MICRO POWER ELECTRONICS, INC.
Reel/Frame 060938/0069 →
SECURITY INTEREST Recorded Sep 10, 2021
From: GREATBATCH LTD.; ELECTROCHEM SOLUTIONS, INC.; LAKE REGION MEDICAL, INC.; LAKE REGION MANUFACTURING, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
Reel/Frame 057468/0056 →
SECURITY INTEREST Recorded Oct 27, 2015
From: GREATBATCH, INC.; GREATBATCH LTD.; ELECTROCHEM SOLUTIONS, INC.; NEURONEXUS TECHNOLOGIES, INC.; GREATBATCH-GLOBE TOOL, INC.; PRECIMED INC.; MICRO POWER ELECTRONICS, INC.
To: MANUFACTURERS AND TRADERS TRUST COMPANY
Reel/Frame 036980/0482 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 15, 2015
From: KATRA, RODOLPHE
To: GREATBATCH LTD.
Reel/Frame 035840/0371 →