IP Library Granted Patent US 11,141,070
Granted Patent B2
US 11,141,070 · App. 15/327,048 · Granted Oct 12, 2021

Heart failure evaluation method and diagnosis device

Inventor: Sadayoshi Matsumoto (Tokyo, JP)
Assignee: Teijin Pharma Limited
A61B5/02A61B5/021A61B5/0205A61B5/02007A61B5/029A61B5/02028A61B5/02405A61B5/08A61B5/0816A61B5/091A61B5/14542A61B5/4035A61B5/7275A61B10/00G16H50/30A61B5/7264A61B2505/07
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Quick Facts
Patent No.
US 11,141,070
App. No.
15/327,048
Granted
Oct 12, 2021
Kind
B2
Abstract

Provided are a means to detect a plurality of dynamics, a processing unit that calculates a temporal change in the detected dynamics, and an evaluation device that determines exacerbation of clinical conditions in heart failure of a patient based on the calculated change in the patient's dynamics over time. The present invention makes it possible to detect, early and with high accuracy, that the onset of acute heart failure is imminent.

Claims (57)

1. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

one or more detectors configured to continuously detect a plurality of physiological indexes of the patient that are different from each other, in a first observation period and in a second observation period; and

a processor configured to:

determine whether to generate the information for the patient according to the first observation period in which a compensatory mechanism of the patient is indicated as functioning or to the second observation period during which a breakdown of the compensatory mechanism is indicated, wherein the compensatory mechanism is a patient function which aims at improving the clinical conditions which deteriorate due to falling of a heart pumping function of the patient, and

generate and output the information that a medical professional uses for at least one of an observation or a diagnosis of the patient, based on the plurality of physiological indexes,

wherein the processor is further configured to generate the information so that at least one aspect of the following (1) to (4) aspects is made different between generating the information in the first observation period and generating the information in the second observation period:

(1) a selection of physiological indexes among the plurality of physiological indexes to be used for the generating the information,

(2) an order of priority of each of the selected physiological indexes used for the generating the information,

(3) a weight for each of the selected physiological indexes, respectively, used for the generating the information, and

(4) a determination threshold for each of the selected physiological indexes, respectively, used for the generating the information.

2. The diagnosis device according to claim 1 , wherein the processor is further configured to select at least one of (a) an augmentation state of a sympathetic nervous system, (b) a state of a vasoconstriction, or (c) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of a ventilation, of the patient, as at least one physiological index, among the plurality of physiological indexes, to be used for the generating the information during the first observation period.

3. The diagnosis device according to claim 1 , wherein the processor is further configured to select at least one of (d) cardiac output, (e) blood pressure, (f) oxygen saturation in blood, (c) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of a ventilation, or (g) an arrhythmic state, of the patient, as at least one physiological index, among the plurality of physiological indexes, to be used for the generating the information during the second observation period.

4. The diagnosis device according to claim 1 , wherein the processor is further configured to generate the information based on at least one event among following (A) to (F) events related to at least one physiological index of the plurality of physiological indexes detected by the one or more detectors:

(A) the at least one physiological index exceeding a predetermined upper limit threshold,

(B) the at least one physiological index being less than a predetermined lower limit threshold,

(C) the at least one physiological index exceeding a predetermined elevation limit threshold per a predetermined time,

(D) the at least one physiological index exceeding a predetermined decline limit threshold per a predetermined time,

(E) the at least one physiological index exceeding a predetermined elevation rate limit threshold, and

(F) the at least one physiological index exceeding a predetermined decline rate limit threshold.

5. The diagnosis device according to claim 4 , wherein the processor is further configured to, based on at least one piece of information about a period during which the at least one event occurred and continued, generate the information about a number of occurrences of the at least one event and a total amount of time during which the at least one event occurred and continued within a predetermined period.

6. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

a processor configured to:

based on the patient being in a state in which a compensatory mechanism of the patient is assumed to be functioning, generate and output the information for at least one of a prediction in an exacerbation of the patient or a diagnosis of the patient, based on information of a physiological index including at least one of (a) an augmentation state of a sympathetic nervous system, (b) a state of a vasoconstriction, or (c) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of a ventilation, of the patient,

wherein the compensatory mechanism of the patient is a patient function which aims at improving the clinical conditions which deteriorate due to falling of a heart pumping function of the patient.

7. The diagnosis device according to claim 6 , wherein the processor is further configured to generate the information based on at least one event among following (A) to (F) events related to the physiological index:

(A) the physiological index exceeding a predetermined upper limit threshold,

(B) the physiological index being less than a predetermined lower limit threshold,

(C) the physiological index exceeding a predetermined elevation limit threshold per a predetermined time,

(D) the physiological index exceeding a predetermined decline limit threshold per a predetermined time,

(E) the physiological index exceeding a predetermined elevation rate limit threshold, and

(F) the physiological index exceeding a predetermined decline rate limit threshold.

8. The diagnosis device according to claim 7 , wherein the processor is further configured to, based on at least one piece of information about a period during which the at least one event occurred and continued, generate the information about a number of occurrences of the at least one event, and a total amount of time during which the at least one event occurred and continued within a predetermined period.

9. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

one or more detectors configured to continuously detect a plurality of physiological indexes of the patient that are different from each other; and

a processor configured to generate and output the information that a medical professional uses for at least one of an observation or a diagnosis of the patient, based on the plurality of physiological indexes,

wherein the processor is further configured to generate the information so that at least one aspect of following (1) to (4) aspects is made different according to one or more of a progressive stage of the chronic heart failure of the patient, a severity of the chronic heart failure of the patient, and background diseases of the patient:

(1) a selection of physiological indexes among the plurality of physiological indexes to be used for the generating the information,

(2) an order of priority of each of the selected physiological indexes used for the generating the information,

(3) a weight for each of the selected physiological indexes, respectively, used for the generating the information, and

(4) a determination threshold for each of the selected physiological indexes, respectively, used for the generating the information.

10. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

a plurality of detectors configured to continuously detect a plurality of physiological indexes of the patient that are different from each other; and

a processor configured to generate and output the information that a medical professional uses for at least one of an observation or a diagnosis of the patient, based on the plurality of physiological indexes,

wherein the processor is further configured to generate the information based on the plurality of physiological indexes including at least one of (I) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of ventilation of the patient, or (II) an index indicating an augmentation state of a sympathetic nervous system of the patient.

11. The diagnosis device according to claim 10 , wherein the processor is further configured to generate the information for the patient whose compensatory mechanism is assumed to be functioning,

wherein the compensatory mechanism is a patient function which aims at improving the clinical conditions which deteriorate due to falling of a heart pumping function, of the patient.

12. The diagnosis device according to claim 10 , wherein the index indicating the augmentation state of the sympathetic nervous system comprises one or more indexes selected from a group consisting of a heart rate variable (HRV), a pulse rate, a blood pressure, and a vasoconstriction, of the patient.

13. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

a plurality of detectors configured to continuously detect a plurality of physiological indexes of the patient that are different from each other; and

a processor configured to generate and output the information that a medical professional uses for at least one of an observation or a diagnosis of the patient, based on the plurality of physiological indexes,

wherein the processor is further configured to generate the information based on the plurality of physiological indexes including at least one of (I) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of a ventilation, of the patient, or (II) a cardiac output of the patient.

14. The diagnosis device according to claim 13 , wherein the processor is further configured to generate the information for the patient who is in a breakdown stage of a compensatory mechanism of the patient,

wherein the compensatory mechanism is a patient function which aims at improving the clinical conditions which deteriorate due to falling of a heart pumping function, of the patient.

15. A diagnosis device for providing information related to changes in clinical conditions of a patient having a chronic heart failure, the diagnosis device comprising:

a plurality of detectors configured to continuously detect a plurality of physiological indexes of the patient that are different from each other; and

a processor configured to generate and output the information that a medical professional uses for at least one of an observation or a diagnosis of the patient, based on the plurality of physiological indexes,

wherein the processor is further configured to generate the information based on the plurality of physiological indexes including at least one of (I) at least one of a respiratory frequency, an index indicating a respiratory stability, or an amount of a ventilation, of the patient, (II) an index indicating an augmentation state of a sympathetic nervous system of the patient, or (III) a cardiac output of the patient.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2023
From: TEIJIN PHARMA LIMITED
To: TEIJIN LIMITED
Reel/Frame 063304/0766 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 18, 2017
From: MATSUMOTO, SADAYOSHI
To: TEIJIN PHARMA LIMITED
Reel/Frame 041005/0208 →
Priority Claims (1)
JP JP2014-149263 · Jul 22, 2014 · national
Continuity (1)
Related Publication 20170164840A1 · Jun 15, 2017
Cited By (1)
US 12,611,115