# US 9,436,801 B2 · Hemodynamic status assessment

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- Number: US 9,436,801 B2
- Document ID: US9436801B2
- Status: Granted
- Kind: B2
- Application number: 14/000,844
- Filed: 2011-03-18
- Published: 2013-12-05
- Granted: 2016-09-06
- Earliest claimed: 2011-03-18
- Assignees: St. Jude Medical, Inc.
- Applicants: Karin Jarverud; Anders Bjorling; Malin Hollmark; Kjell Noren; Tomas Svensson; Stefan Hjelm
- Inventors: Karin Jarverud; Anders Bjorling; Malin Hollmark; Kjell Noren; Tomas Svensson; Stefan Hjelm
- Web page: https://patentgrep.com/patent/US9436801B2

## CPC

- A61B 5/0538: invasively, e.g. using a catheter
- A61N 1/36521: {the parameter being derived from measurement of an electrical impedance}
- G16H 40/63: for local operation
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/363: Detecting tachycardia or bradycardia
- A61N 1/36535: {controlled by body position or posture}
- G16B 5/00: ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
- G16B 40/00: ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

## Abstract

A patient-specific hemodyanmic status model is determined from impedance data collected during periods of normal and abnormal hemodynamic status by deriving parameter values of a set of multiple impedance-derivable parameters from impedance signals collected during periods of normal hemodynamic status and in connection with periods of abnormal hemodynamic status. The parameter values are employed to estimate coefficients of a linear parametric status model. These coefficients can then be used together with parameter values determined from impedance signals determined during status assessment periods in order to determine a current hemdoynamic status of the patient.

## Claims

### Claim 1

A system for determining a hemodynamic status model and providing therapy based on the hemodynamic status model, the system comprising:
a lead connector electrically connectable to at least two electrodes of at least one electric lead;
a signal generator connected to the lead connector and configured to generate, during a period of normal hemodynamic status of a subject and in connection with a period of abnormal hemodynamic status of the subject, electric signals applicable over two electrodes of the at least two electrodes;
a signal sensing unit connected to the lead connector and configured to sense, during the period of normal hemodynamic status of the subject and in connection with the period of abnormal hemodynamic status of the subject, resulting electric signals over two electrodes of the at least two electrodes;
an impedance processor configured to determine a first impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject and determine a second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject;
a parameter processor configured to calculate first parameter values of a set of N different impedance-derivable parameters based on the first impedance signal and calculate second parameter values of the set of N different impedance-derivable parameters based on the second impedance signal, N is a positive integer equal to or larger than two;
a model processor configured to estimate based on the first parameter values and the second parameter values, N+1 coefficients of a linear parametric status model
Index
j
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
j
,
where j=1, 2C0,Ci represent the N+1 coefficients, fi1 represent the first parameter values, fi2 represent the second parameter values, Index1 has a predefined first value representative of normal hemodynamic status of the subject and Index2 has a predefined second value representative of abnormal hemodynamic status of the subject;
a memory configured to store the N+1 coefficients as representations of the linear parametric status model;
a tachyarrhythmia detector configured to generate a tachyarrhythmia signal in response to a tachyarrhythmia period of the subject detected by the tachyarrhythmia detector based on electric signals sensed from a heart of the subject by at least one electric lead of the at least one electric lead, wherein
the signal generator is configured to generate, in connection with the period of abnormal hemodynamic , status of the subject and in response to the tachyarrhythmia signal, the electric signals applicable over the two electrodes of the at least two electrodes;
the signal sensing unit is configured to sense, in connection with the period of abnormal hemodynamic status of the subject and in response to the tachyarrhythmia signal, the resulting electric signals over the two electrodes of the at least two electrodes; and
a therapy selector to provide therapy based on the tachyarrhythmia detector.

### Claim 2 (depends on 1)

The system according to claim 1, further comprising a posture sensor configured to generate a posture signal representative of a current posture of the subject, wherein the signal generator is configured to generate the electric signal when the posture signal indicates that the subject is in a predefined target posture.

### Claim 3

A system for determining a hemodynamic status model and providing therapy based on the hemodynamic status model, the system comprising:
a lead connector electrically connectable to at least two electrodes of at least one electric lead;
a signal generator connected to the lead connector and configured to generate, during a period of normal hemodynamic status of a subject and in connection with a period of abnormal hemodynamic status of the subject, electric signals applicable over two electrodes of the at least two electrodes;
a signal sensing unit connected to the lead connector and configured to sense, during the period of normal hemodynamic status of the subject and in connection with the period of abnormal hemodynamic status of the subject, resulting electric signals over two electrodes of the at least two electrodes;
an impedance processor configured to determine a first impedance signals based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject and determine a second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject;
a parameter processor configured to calculate first parameter values of a set of N different impedance-derivable parameters based on the first impedance signal and calculate second parameter values of the set of N different impedance-derivable parameters based on the second impedance signal, N is a positive integer equal to or larger than two;
a model processor configured to estimate, based on the first parameter values and the second parameter values, N+1 coefficients of a linear parametric status model
Index
j
=
c
0
+
∑
i
=
1
N
⁢
⁢
c
i
⁢
f
i
j
,
where j=1, 2C0, Ci represent the N+1 coefficients, fi1 represent the first parameter values, fi2 represent the second parameter values, Index1 has a predefined first value representative of normal hemodynamic status of the subject and Index2 has a predefined second value representative of abnormal hemodynamic status of the subject;
a memory configured to store the N+1 coefficients as representations of the linear parametric status model;
a posture sensor configured to generate a posture signal representative of a current posture of the subject, wherein
the signal generator is configured to generate, during the period of normal hemodynamic status of the subject and when the posture signal represents a first predefined posture of the subject, during the period of normal hemodynamic status of the subject and when the posture signal represents a second predefined posture of the subject, in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the first predefined posture of the subject, and in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the second predefined posture of the subject, the electric signals applicable over two electrodes of the at least two electrodes;
the signal sensing unit is configured to sense, during the period of normal hemodynamic status of the subject and when the posture signal represents the first predefined posture of the subject, during the period of normal hemodynamic status of the subject and when the posture signal represents the second predefined posture of the subject, in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the first predefined posture of the subject, and in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the second predefined posture of the subject, the resulting electric signals over two electrodes of the at least two electrodes;
the impedance process or is configured to determine the first impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject and when the posture signal represents the first predefined posture of the subject, determine the second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the first predefined posture of the subject, determine a third impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject, and when the posture signal represents the second predefined posture of the subject, and determine a fourth impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject and when the posture signal represents the second predefined posture of the subject;
the parameter processor is configured to calculate the first parameter values of the set of N different impedance-derivable parameters based on the first impedance signal, calculate the second parameter values of the set of N different impedance-derivable parameters based on the second impedance signal, calculate third parameter values of the set of N different impedance-derivable parameters based on the third impedance signal and calculate fourth parameter values of the set of N different impedance-derivable parameters based on the fourth impedance signal;
the model processor is configured to estimate, based on the first parameter values and the second parameter values, N+1 coefficients of a first linear parametric status model
Index
1
j
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
j
,
where j=1, 2, c0, ci represent the N+1 coefficients, fi1 represent the first parameter values, fi2 represent the second parameter values, Index11 has the predefined first value representative of normal hemodynamic status of the subject and Index12 has the predefined second value representative of abnormal hemodynamic status of the subject and estimate, based on the third parameter values and the fourth parameter values, N+1 coefficients of a second linear parametric status model
Index
2
j
=
d
0
+
∑
i
=
1
N
⁢
d
i
⁢
g
i
j
,
where j=1, 2, d0, di represent the N+1 coefficients, gi1 represent the third parameter values, gi2 represent the fourth parameter values, Index21 has the predefined first value representative of normal hemodynamic status of the subject and Index22 has the predefined second value representative of abnormal hemodynamic status of the subject;
the memory is configured to store the 2(N+1) coefficients as representations of the first and second linear parametric status models; and
a therapy selector to provide therapy based on the determined hemodynamic status of the subject.

### Claim 4

An implantable medical device comprising:
a lead connector electrically connectable to at least two electrodes of the at least one electric lead;
a signal generator connected to the lead connector and configured to generate, during a status assessment period, electric signals applicable over two electrodes of the at least two electrodes;
a signal sensing unit connected to the lead connector and configured to sense, during the status assessment period, resulting electric signals over two electrodes of the at least two electrodes;
an impedance processor configured to determine an impedance signal based on the electric signals applied and the resulting electric signals sensed during the status assessment period;
a parameter processor configured to calculate parameter values of a set of N different impedance-derivable parameters based on the impedance signal;
a status processor configured to a calculate an index representative of a current hemodynamic status of a subject based on the parameter values calculated by the parameter processor and N+1 coefficients of a linear parametric status model
Index
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
,
wherein c0, ci represent the N+1 coeffieients and fi represent the parameter values calculated by the d parameter processor;
a posture sensor configured to generate a posture signal representative of a current posture of the subject; and
a model selector configured to select between a first linear parametric status model
Index
1
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
and a second linear parametric status model
Index
2
=
d
0
+
∑
i
=
1
N
⁢
d
i
⁢
f
i
based on the posture signal, wherein c0, ci represent N+1 coefficients applicable when the subject is in a first posture and d0, di represent N+1 coefficients applicable when the subject is in a second posture; and
a therapy selector to provide therapy based on the determined hemodynamic status of the subject.

### Claim 5

A method of determining a hemodynamic status model, and providing therapy based on the hemodynamic status model, the method comprising:
generating, during a period of normal hemodynamic status of a subject and in connection with a period of abnormal hemodynamic status of the subject, electric signals applicable over two electrodes of at least one electric lead;
sensing, during the period of normal hemodynamic status of the subject and in connection with the period of abnormal hemodynamic status of the subject, resulting electric signals over two electrodes of the at least one electric lead;
determining a first impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject;
determining a second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject;
calculating first parameter values of a set of N different impedance-derivable parameters based on the first impedance signal;
calculating second parameter values of the set of N different impedance-derivable parameters based on the second impedance signal, N is a positive integer equal to or larger than two;
estimating, based on the first parameter values and the second parameter values, N+1 coefficients of a linear parametric status model
Index
j
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
j
,
where j=1, 2c0, ci represent N+1 coefficients, fi1 represent the first parameter values, fi2 represent the second parameter values, Index1 has a predefined first value representative of normal hemodynamic status of the subject; and Index2 has a predefined second value representative of abnormal hemodynamic status of the subject;
storing said N+1 coefficients as representations of the linear parametric status model in a memory;
detecting a tachyarrhythmia period of the subject based on electric signals sensed from a heart of the subject by at least one electric lead of the at least one electric lead, wherein
generating the electric signals in connection with the period of abnormal hemodynamic status comprises generating, in connection with the period of abnormal hemodynamic status of the subject and in response to the detected tachyarrhythmia period, the electric signals applicable over the two electrodes;
sensing the resulting electric signals in connection with the period of abnormal hemodynamic status comprises sensing, in connection with the period of abnormal hemodynamic status of the subject and in response to the detected tachyarrhythmia period, the resulting electric signals over the two electrodes; and
providing therapy based on the determined hemodynamic status of the subject.

### Claim 6

A method of determining a hemodynamic status model and providing therapy based on the hemodynamic status model, the method comprising:
generating, during a period of normal hemodynamic status of a subject and in connection with a period of abnormal hemodynamic status of the subject, electric signals applicable over two electrodes of at least one electric lead;
sensing, during the period of normal hemodynamic status of the subject and in connection wit the period of abnormal hemodynamic status of the subject, resulting electric signals over two electrodes of the at least one electric lead;
determining a first impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject;
determining a second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject;
calculating first parameter values of a set of N different impedance-derivable parameters based on the first impedance signal;
calculating second parameter values of the set of N different impedance-derivable parameters based on the second impedance signal, N is a positive integer equal to or larger than two;
estimation, based on the first parameter values and the second parameter values, N+1 coefficients of a linear parametric status model
Index
j
=
c
0
+
∑
i
=
1
N
⁢
⁢
c
i
⁢
f
i
j
,
where j=1, 2c0, ci represent said N+1 coefficients, fi1 respesent the first parameter values, fi2 represent the second parameter values, Index1 has a predefined first value representative of normal hemodynamic status of the subject and Index2 has a predefined second value representative of abnormal hemodynamic status of the subject;
storing said N+1 coefficients as representations of the linear parametric status model in a memory;
detecting a current posture of the subject, wherein
generating the electric signals comprises generating, during the period of normal hemodynamic status of the subject and when the current posture is a first predefined posture of the subject, during the period of normal hemodynamic status of the subject and when the current posture is a second predefined posture of the subject, in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the first predefined posture of the subject, and in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the second predefined posture of the subject, the electric signals applicable over the two electrodes;
sensing the resulting electric signals comprises sensing, during the period of normal hemodynamic status of the subject and when the current posture is the first predefined posture of the subject, during the period of normal hemodynamic status of the subject and when the current posture is the second predefined posture of the subject, in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the first predefined posture of the subject, and in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the second predefined posture of the subject, the resulting electric signals over the two electrodes;
determining the first impedance signal comprises determining the first impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of subject and when the current posture is the first predefined posture of the subject;
determining the second impedance signal comprises determining the second impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the first predefined posture of the subject, the method further comprises:
determining a third impedance signal based on the electric signals applied and the resulting electric signals sensed during the period of normal hemodynamic status of the subject and when current posture is the second predefined posture of the subject;
determining a fourth impedance signal based on the electric signals applied and the resulting electric signals sensed in connection with the period of abnormal hemodynamic status of the subject and when the current posture is the second predefined posture of the subject;
calculating third parameter values of the set of N different impedance-derivable parameters based on the third impedance signal; and
calculating fourth parameter values of the set of N different impedance-derivable parameters based on the fourth impedance signal, wherein estimating the N+1 coefficients comprises:
estimating, based on the first parameter values and the second parameter values, N+1 coefficients of a first linear parametric status model
Index
1
j
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
j
,
where j=1, 2, c0, ci represent the N+1 coefficients, fi1 represent the first parameter values, fi2 represent the second parameter values, Index11 has the predefined first value representative of normal hemodynamic status of the subject and Index12 has the predefined second value representative of abnormal hemodynamic status of the subject;
estimating, based on the third parameter values and the fourth parameter values, N+1 coefficients of a second linear parametric status model
Index
2
j
=
d
0
+
∑
i
=
1
N
⁢
d
i
⁢
g
i
j
,
where j=1, 2, d0, di represent the N+1 coefficients, gi1 represent the third parameter values, gi2 represent the fourth parameter values, Index21 has the predefined first value representative of normal hemodynamic status of the subject and Index22 has the predefined second value representative of abnormal hemodynamic status of the subject; and
storing the N+1 coefficients comprises storing the 2(N+1) coefficients as representations of the first and second linear parametric status models; and
providing therapy based on the determined hemodynamic status of the subject.

### Claim 7

A method of assessing a hemodynamic status of a subject and providing therapy based on the hemodynamic status, the method comprising:
generating, during a status assessment period, electric signals applicable over two electrodes of at least one electric lead;
sensing, during the status assessment period, resulting electric signals over two electrodes of the at least one electric lead;
determining an impedance signal based on the electric signals applied and the resulting electric signals sensed during the status assessment period;
calculating parameter values of a set of N different impedance-derivable parameters based on the impedance signal;
calculating an index representative of a current hemodynamic status of the subject based on the parameter values and N+1 coefficients of a linear parametric status model
Index
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
,
wherein c0, ci represent the N+1 coefficients and fi represent the parameter values;
detecting a current posture of the subject;
selecting between a first linear parametric status model
Index
1
=
c
0
+
∑
i
=
1
N
⁢
c
i
⁢
f
i
and a second linear parametric status model
Index
2
=
d
0
+
∑
i
=
1
N
⁢
d
i
⁢
f
i
based on the current posture, wherein c0, ci represent N+1 coefficients applicable when the subject is in a first posture and d0, di represent N+1 coefficients applicable when the subject is in a second posture; and
providing therapy based on the determined hemodynamic status of the subject.