# US 8,571,620 B2 · Tissue oxygenation monitoring in heart failure

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- Number: US 8,571,620 B2
- Document ID: US8571620B2
- Status: Granted
- Kind: B2
- Application number: 12/797,816
- Filed: 2010-06-10
- Published: 2010-12-16
- Granted: 2013-10-29
- Earliest claimed: 2009-06-10
- Assignees: Medtronic, Inc.
- Applicants: Can Cinbis; James K. Carney; Jonathan L. Kuhn; David A. Anderson
- Inventors: Can Cinbis; James K. Carney; Jonathan L. Kuhn; David A. Anderson
- Web page: https://patentgrep.com/patent/US8571620B2

## CPC

- A61N 1/36557: {controlled by chemical substances in blood}
- 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)

## Abstract

A medical device system and associated method are used for monitoring a heart failure patient. A medical device for monitoring delivery of a therapy includes a sensor sensing an optical sensor signal corresponding to light attenuation by a volume of body tissue of a patient, a therapy delivery module to deliver a therapy, and a processor configured to compute a first tissue oxygenation measurement from the optical sensor signal prior to initiating delivery of the therapy, compute a second tissue oxygenation measurement from the optical sensor signal subsequent to initiating delivery of the therapy, compare the first and the second tissue oxygenation measurements, and determine whether the delivered therapy was successful in response to the first tissue oxygenation measurement and the second tissue oxygenation measurement.

## Claims

### Claim 1

A medical device for monitoring delivery of a therapy, comprising:
a sensor sensing an optical sensor signal corresponding to light attenuation by a volume of body tissue of a patient;
a therapy delivery module to deliver the therapy; and
a processor configured to compute a first tissue oxygenation measurement from the optical sensor signal prior to initiating delivery of the therapy, compute a second tissue oxygenation measurement from the optical sensor signal subsequent to initiating delivery of the therapy, compare the first and the second tissue oxygenation measurements, and determine whether the delivered therapy was successful in response to the first tissue oxygenation measurement and the second tissue oxygenation measurement, wherein the processor determines whether the delivered therapy was successful in response to the second tissue oxygenation measurement being greater than the first tissue oxygenation measurement.

### Claim 2 (depends on 1)

The device of claim 1, wherein the processor is further configured to adjust a parameter controlling delivery of the therapy in response to the second tissue oxygenation measurement being not greater than the first tissue oxygenation measurement, compute a tissue oxygenation measurement from the sensor signal for the adjusted parameter, and continue to adjust the parameter and compute the tissue oxygenation measurement until a parameter setting resulting in a tissue oxygenation measurement that is greater than the first tissue oxygenation measurement is identified and determine whether the delivered therapy was successful in response to the identified parameter setting.

### Claim 3 (depends on 1)

The device of claim 1, wherein the processor is further configured to adjust a parameter controlling delivery of the therapy to a plurality of settings, compute a tissue oxygenation measurement for each of the plurality of settings, determine a setting for the parameter corresponding to a maximum tissue oxygenation, and deliver the therapy using the determined parameter setting.

### Claim 4 (depends on 3)

The device of claim 3, further comprising an activity sensor to sense an activity sensor signal corresponding to activity of the patient, wherein the processor is further configured to sense detect a change in activity level of the patient from the activity sensor signal, compute a tissue oxygenation measurement in response to detecting the change in activity level, detect a decrease in tissue oxygenation in response to the tissue oxygenation measurement computed in response to detecting the change in activity level, and adjust a parameter controlling delivery of the therapy in response to detecting the decreased tissue oxygenation.

### Claim 5 (depends on 1)

The device of claim 1, wherein computing the first tissue oxygenation measurement and the second tissue oxygenation measurement comprises computing a second derivative of light attenuation with respect to wavelength and computing a tissue oxygen saturation using the second derivative.

### Claim 6 (depends on 5)

The device of claim 5, wherein computing the first tissue oxygenation measurement and the second tissue oxygenation measurement further comprises computing a total hemoglobin volume fraction using the tissue oxygen saturation.

### Claim 7 (depends on 5)

The device of claim 5, wherein computing the first tissue oxygenation measurement and the second tissue oxygenation measurement further comprises computing a tissue oxygenation index as a function of the tissue oxygen saturation and the total hemoglobin volume fraction.

### Claim 8

A method for monitoring delivery of a therapy in a medical device, comprising;
sensing an optical sensor signal corresponding to light attenuation by a volume of body tissue of a patient;
initiating delivery of the therapy;
computing a first tissue oxygenation measurement from the optical sensor signal prior to initiating deliver of the therapy;
computing a second tissue oxygenation measurement from the optical sensor signal subsequent to initiating delivery of the therapy;
comparing the first and the second tissue oxygenation measurements; and
determining whether the therapy was successful in response to the second tissue oxygenation measurement being greater than the first tissue oxygenation measurement.

### Claim 9 (depends on 8)

The method of claim 8, further comprising:
adjusting a parameter controlling delivery of the therapy in response to the second tissue oxygenation measurement not being greater than the first tissue oxygenation measurement;
computing a tissue oxygenation measurement from the optical sensor signal for the adjusted parameter; and
continuing to adjust the parameter and compute the tissue oxygenation measurement until a parameter setting resulting in a tissue oxygenation measurement that is greater than the first tissue oxygenation measurement is identified and determining that the therapy was successful in response to the identified parameter setting.

### Claim 10 (depends on 8)

The method of claim 8, further comprising:
adjusting a parameter controlling delivery of the therapy to a plurality of settings;
computing a tissue oxygenation measurement for each of the plurality of settings;
determining a setting for the parameter corresponding to a maximum tissue oxygenation; and
delivering the therapy using the determined parameter setting.

### Claim 11 (depends on 10)

The method of claim 10, further comprising:
sensing an activity sensor signal;
detecting a change in activity level of the patient from the activity sensor signal;
computing a tissue oxygenation measurement in response to detecting the change in activity level;
detecting a decrease in tissue oxygenation in response to the tissue oxygenation measurement computed in response to detecting the change in activity level; and
adjusting a parameter controlling delivery of the therapy in response to detecting the decreased tissue oxygenation.

### Claim 12 (depends on 10)

The method of claim 10, wherein computing the tissue oxygenation measurement comprises computing a second derivative of light attenuation with respect to wavelength and computing a tissue oxygen saturation in response to the second derivative.

### Claim 13 (depends on 12)

The method of claim 12, wherein computing the tissue oxygenation measurement comprises computing a total hemoglobin volume fraction in response to the tissue oxygen saturation.

### Claim 14 (depends on 13)

The method of claim 13, wherein computing the tissue oxygenation measurement comprises computing a tissue oxygenation index as a function of the tissue oxygen saturation and the total hemoglobin volume fraction.

### Claim 15

A non-transitory computer readable medium having computer executable instructions for performing a method comprising:
sensing an activity sensor signal;
detecting a change in activity level of the patient from the activity sensor signal;
computing a first tissue oxygenation measurement in response to detecting the change in activity level;
computing a second tissue oxygenation measurement in response to detecting the change in activity level;
detecting a decrease in tissue oxygenation in response to the first tissue oxygenation measurement computed in response to detecting the change in activity level;
adjusting a parameter controlling delivery of the therapy in response to detecting the decreased tissue oxygenation;
comparing the first tissue oxygenation measurement to the second tissue oxygenation measurement; and
determining whether the therapy was successful in response to the second tissue oxygenation measurement being greater than the first tissue oxygenation measurement.

### Claim 16 (depends on 15)

The computer readable medium of claim 15, wherein the method further comprises:
adjusting a parameter controlling delivery of the therapy in response to the second tissue oxygenation measurement not being greater than the first tissue oxygenation measurement;
computing a tissue oxygenation measurement from the optical sensor signal for the adjusted parameter; and
continuing to adjust the parameter and compute the tissue oxygenation measurement until a parameter setting resulting in a tissue oxygenation measurement that is greater than the first tissue oxygenation measurement is identified and determining that the therapy was successful in response to the identified parameter setting.

### Claim 17 (depends on 15)

The computer readable medium of claim 15, wherein the method further comprises:
adjusting a parameter controlling delivery of the therapy to a plurality of settings;
computing a tissue oxygenation measurement for each of the plurality of settings;
determining a setting for the parameter corresponding to a maximum tissue oxygenation; and
delivering the therapy using the determined parameter setting.

### Claim 18 (depends on 17)

The computer readable medium of claim 17, wherein the method further comprises:
sensing an activity sensor signal;
detecting a change in activity level of the patient from the activity sensor signal;
computing a tissue oxygenation measurement in response to detecting the change in activity level;
detecting a decrease in tissue oxygenation in response to the tissue oxygenation measurement computed in response to detecting the change in activity level; and
adjusting a parameter controlling delivery of the therapy in response to detecting the decreased tissue oxygenation.

### Claim 19 (depends on 17)

The computer readable medium of claim 17, wherein computing the tissue oxygenation measurement comprises computing a second derivative of light attenuation with respect to wavelength and computing a tissue oxygen saturation in response to the second derivative.

### Claim 20 (depends on 19)

The computer readable medium of claim 19, wherein computing the tissue oxygenation measurement comprises computing a total hemoglobin volume fraction in response to the tissue oxygen saturation.

### Claim 21 (depends on 20)

The computer readable medium of claim 20, wherein computing the tissue oxygenation measurement comprises computing a tissue oxygenation index as a function of the tissue oxygen saturation and the total hemoglobin volume fraction.
