# US 12,599,321 B2 · Devices and methods for assessing pulmonary status using optical oxygenation sensing

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- Number: US 12,599,321 B2
- Document ID: US12599321B2
- Status: Granted
- Kind: B2
- Application number: 17/864,907
- Filed: 2022-07-14
- Published: 2023-01-19
- Granted: 2026-04-14
- Earliest claimed: 2021-07-19
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Jeffrey E. Stahmann; Keith R. Maile
- Web page: https://patentgrep.com/patent/US12599321B2

## CPC

- A61B 5/14552: {Details of sensors specially adapted therefor}
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/0803: {Recording apparatus specially adapted therefor}
- A61B 5/14551: {for measuring blood gases}
- A61B 5/4842: {Monitoring progression or stage of a disease}
- A61B 5/6867: {specially adapted to be attached or implanted in a specific body part (A61B5/6847 takes precedence)}
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/091: Measuring volume of inspired or expired gases, e.g. to determine lung capacity
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/6831: {Straps, bands or harnesses}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Embodiments herein relate to devices and methods for assessing pulmonary status using optical oxygenation sensing. In an embodiment, an oxygenation monitoring device can be included having a first optical emitter, wherein the first optical emitter can be configured to emit light at a first wavelength from 100 nanometers (nm) to 2000 nm. The oxygenation monitoring device and further include a first optical detector, wherein the first optical detector can be configured to detect incident light. The device can be configured so that emitted light from the first optical emitter propagates through a lung tissue and detected incident light can be used to determine an oxygenation status of the lung tissue. Other embodiments are also included herein.

## Claims

### Claim 1

An oxygenation monitoring device comprising:
an implantable housing defining an interior volume, the implantable housing comprising:
control circuitry disposed within the interior volume;
a first optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the first optical emitter is configured to emit light at a first wavelength from 100 nanometers (nm) to 2000 nm;
a second optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the second optical emitter is configured to emit light at a second wavelength that is different from the first wavelength; and
a first optical detector coupled to the implantable housing and in electrical communication with the control circuitry, wherein the first optical detector is configured to detect incident light;
wherein the first optical emitter is spaced a first distance away from the first optical detector along a planar surface of the device;
wherein the second optical emitter is spaced a second distance away from the first optical detector along the planar surface of the device, wherein the first distance is greater than the second distance;
wherein the emitted light from the first optical emitter propagates through the lung tissue simultaneously with the emitted light from the second optical emitter;
wherein emitted light from the first optical emitter propagates through a lung tissue to a first depth; and
wherein emitted light from the second optical emitter propagates through the lung tissue to a second depth, wherein the first depth is greater than the second depth;
wherein the control circuitry determines an oxygenation status of the lung tissue using a ratio of a first molar extinction coefficient at the first wavelength to a second molar extinction coefficient at the second wavelength; and
wherein the device is implantable in a subcutaneous tissue of a patient.

### Claim 2 (depends on 1)

The device of claim 1, wherein the device is configured so that emitted light from the first optical emitter propagates through tissue at a depth of at least 1 cm as measured from a surface of the device and back to the first optical detector.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first wavelength is from 550 nm to 1000 nm.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first optical emitter and the first optical detector are spaced along a length of the oxygenation monitoring device at from 1 cm to 10 cm apart.

### Claim 5 (depends on 1)

The device of claim 1, wherein the first wavelength is from 600 nm to 800 nm.

### Claim 6 (depends on 1)

The device of claim 1, wherein the second wavelength is from 800 nm to 2000 nm.

### Claim 7 (depends on 1)

The device of claim 1, wherein emitted light from the first optical emitter is propagated to a different depth than emitted light from the second optical emitter.

### Claim 8 (depends on 1)

The device of claim 1, wherein the device is further configured to determine one of a heart rate, a respiratory rate, a tidal volume, or an extravascular lung water concentration using a secondary sensor.

### Claim 9 (depends on 1)

The device of claim 1, further comprising:
a flexible member, wherein the flexible member is connected to the housing and extends in a direction away from the implantable housing.

### Claim 10 (depends on 9)

The device of claim 9, wherein at least one of the first optical emitter and the optical detector are disposed along a length of the flexible member.

### Claim 11 (depends on 1)

The device of claim 1, wherein the first optical emitter and the optical detector are spaced along the planar surface of the device from 1 cm to 10 cm apart.

### Claim 12 (depends on 1)

The device of claim 1, wherein propagation of the emitted light through a lung tissue comprises propagation of the emitted light from 1 cm to 5 cm in depth as measured from a surface of the oxygenation monitoring device.

### Claim 13 (depends on 1)

The device of claim 1, wherein the first optical emitter is disposed at least 6 cm away from the first optical detector.

### Claim 14 (depends on 1)

The device of claim 1, wherein the emitted light from the first optical emitter propagates through the lung tissue at a depth of at least 3 cm as measured from a surface of the device and back to the first optical detector.

### Claim 15

A method for measuring an oxygenation status in a patient comprising:
bringing an oxygenation monitoring device into contact with a tissue of the patient, the oxygenation monitoring device comprising an optical sensor comprising:
an implantable housing defining an interior volume, the implantable housing comprising:
control circuitry disposed within the interior volume a first optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the first optical emitter is configured to emit light at a first wavelength from 100 nanometers (nm) to 2000 nm;
a second optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the second optical emitter is configured to emit light at a second wavelength that is different from the first wavelength; and
a first optical detector coupled to the implantable housing and in electrical communication with the control circuitry, wherein the first optical detector is configured to detect incident light;
wherein the first optical emitter is spaced a first distance away from the first optical detector along a planar surface of the device;
wherein the second optical emitter is spaced a second distance away from the first optical detector along the planar surface of the device, wherein the first distance is greater than the second distance;
implanting the oxygenation monitoring device subcutaneously at or near a site of a lung tissue so that the first light emitter and the first light detector are directed toward an interior of the patient toward a surface of the lung tissue;
propagating a first emitted light from the first optical emitter at the first wavelength to a region of the lung tissue at a first depth;
propagating a second emitted light from the second optical emitter at the second wavelength to a second region of the lung tissue at a second depth, wherein the first depth is greater than the second depth;
wherein the emitted light from the first optical emitter propagates through the lung tissue simultaneously with the emitted light from the second optical emitter;
detecting an incident light with the optical detector;
determining an oxygenation status of the lung tissue based on the detected incident light;
wherein determining the oxygenation status comprises performing a ratiometric calculation using a ratio of a first molar extinction coefficient at the first wavelength to a second molar extinction coefficient at the second wavelength.

### Claim 16 (depends on 15)

The method of claim 15, wherein the first emitted light is propagated at a depth of from 1 cm to 5 cm into the lung tissue.

### Claim 17 (depends on 15)

The method of claim 15, further comprising monitoring a progression or regression of one or more conditions comprising chronic obstructive pulmonary disease (COPD), pulmonary edema, asthma, pneumonia, airway obstruction, heart failure, acute respiratory distress syndrome (ARDS), septic shock, or pulmonary embolism.
