# US 11,992,301 B2 · Monitoring treatment of peripheral artery disease (PAD) using diffuse optical imaging

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- Number: US 11,992,301 B2
- Document ID: US11992301B2
- Status: Granted
- Kind: B2
- Application number: 17/881,844
- Filed: 2022-08-05
- Published: 2023-02-02
- Granted: 2024-05-28
- Earliest claimed: 2016-04-24
- Assignees: The Trustees of Columbia University in the City of New York
- Applicants: The Trustees of Columbia University in the City of New York
- Inventors: Andreas H. Hielscher; Christopher J. Fong; Jennifer Hoi; Hyun K. Kim; Michael Khalil
- Web page: https://patentgrep.com/patent/US11992301B2

## CPC

- A61B 5/0261: {using optical means, e.g. infrared light}
- A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons
- A61B 5/0073: {by tomography, i.e. reconstruction of 3D images from 2D projections (A61B5/0066 takes precedence)}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/02: Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/022: by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
- A61B 5/02255: {the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors}
- A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/6828: {Leg}
- A61B 5/6829: {Foot or ankle}
- A61B 5/6831: {Straps, bands or harnesses}
- A61B 5/6884: {Clamps or clips}
- A61B 5/7425: {Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image}
- A61B 2560/0437: Trolley or cart-type apparatus
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A plurality of modules are simultaneously positioned at locations that correspond to different angiosomes. Each of these modules has a front surface shaped and dimensioned for contacting a person's skin, a plurality of different-wavelength light sources aimed in a forward direction, and a plurality of light detectors aimed to detect light arriving from in front of the front surface. Each module is supported by a support structure (e.g., a strap or a clip) that is shaped and dimensioned to hold the front surface adjacent to the person's skin at a respective position. Perfusion in each of the angiosomes is monitored using these modules, and the surgeon can rely on this information to guide his or her intervention.

## Claims

### Claim 1

An optical tomography system comprising:
a first transducer having at least one first light source and at least one first light detector;
a second transducer having at least one second light source and at least one second light detector; and
a processor programmed to generate a first time-dependent indication of blood perfusion of a region corresponding to the first transducer based on an output of the at least one first light detector, and to generate a second time-dependent indication of blood perfusion of a region corresponding to the second transducer based on an output the at least one second light detector,
wherein each of the first transducer and the second transducer is configured to releasably attach to a respective one of two separate angiosomes, and
wherein the processor is further programmed to output, in real time during a surgical procedure, both (a) the first time-dependent indication of blood perfusion and (b) the second time-dependent indication of blood perfusion.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first transducer or the second transducer includes a clip configured to clip on the first toe of a human subject.

### Claim 3 (depends on 1)

The system of claim 1, wherein the angiosomes are in the lower leg of a human subject.

### Claim 4 (depends on 3)

The system of claim 3, wherein the first transducer or the second transducer is configured to attach to a human calf.

### Claim 5 (depends on 1)

The system of claim 1, wherein the output includes graphs of hemoglobin concentration and time.

### Claim 6 (depends on 1)

The system of claim 1, further comprising
a third transducer having at least one third light source and at least one third light detector, wherein the third transducer is configured to releasably attach to an additional angiosome,
wherein the processor is further programmed to generate a third time-dependent indication of blood perfusion of a region corresponding to the third transducer based on an output of the at least one third light detector, and
wherein the processor is further programmed to output the third time-dependent indication of blood perfusion in real time during the surgical procedure.

### Claim 7

A method of monitoring treatment of peripheral artery disease, the method comprising:
(a) affixing a first plurality of light sources having different wavelengths and a first plurality of light detectors to a first position on a subject's limb, wherein the first position corresponds to a first angiosome of the limb;
(b) transmitting light from the first plurality of light sources into a first portion of the subject's limb, detecting light reflected from the first portion of the subject's limb using the first plurality of light detectors, and using diffuse optical imaging to determine a level of perfusion in the first angiosome based on the detected light reflected from the first portion;
(c) affixing a second plurality of light sources having different wavelengths and a second plurality of light detectors to a second position on a subject's limb, wherein the second position corresponds to a second angiosome of the limb; and
(d) transmitting light from the second plurality of light sources into a second portion of the subject's limb, detecting light reflected from the second portion of the subject's limb using the second plurality of light detectors, and using diffuse optical imaging to determine a level of perfusion in the second angiosome based on the detected light reflected from the second portion,
wherein the first plurality of light sources and the first plurality of light detectors remain affixed to the first position during steps (b) and (d), and
wherein the second plurality of light sources and the second plurality of light detectors remain affixed to the second position during steps (b) and (d).

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
(e) affixing a third plurality of light sources having different wavelengths and a third plurality of light detectors to a third position on a subject's limb, wherein the third position corresponds to a third angiosome of the limb; and
(f) transmitting light from the third plurality of light sources into a third portion of the subject's limb, detecting light reflected from the third portion of the subject's limb using the third plurality of light detectors, and using diffuse optical imaging to determine a level of perfusion in the third angiosome based on the detected light reflected from the third portion,
wherein the first plurality of light sources and the first plurality of light detectors remain affixed to the first position during steps (b), (d), and (f),
wherein the second plurality of light sources and the second plurality of light detectors remain affixed to the second position during steps (b), (d), and (f), and
wherein the third plurality of light sources and the third plurality of light detectors remain affixed to the third position during steps (b), (d), and (f).

### Claim 9 (depends on 7)

The method of claim 7, wherein steps (b), (d), and (f) are each performed at a first time during which a pressure cuff is not inflated, and further comprising the step of repeating steps (b), (d), and (f) at a second time during which the pressure cuff is inflated.

### Claim 10 (depends on 7)

The method of claim 7, wherein the first angiosome corresponds to a posterior tibial artery, the second angiosome corresponds to a lateral plantar artery, and the third angiosome corresponds to at least one of an anterior tibial artery and a dorsalis pedis artery.

### Claim 11 (depends on 7)

The method of claim 7, further comprising
(g) affixing a fourth plurality of light sources having different wavelengths and a fourth plurality of light detectors to a fourth position on a subject's limb, wherein the fourth position corresponds to a fourth angiosome of the limb; and
(h) transmitting light from fourth plurality of light sources into a fourth portion of the subject's limb, detecting light reflected from the fourth portion of the subject's limb using the fourth plurality of light detectors, and using diffuse optical imaging to determine a level of perfusion in the fourth angiosome based on the detected light reflected from the fourth portion,
wherein the first plurality of light sources and the first plurality of light detectors remain affixed to the first position during steps (b), (d), (f), and (h),
wherein the second plurality of light sources and the second plurality of light detectors remain affixed to the second position during steps (b), (d), (f), and (h),
wherein the third plurality of light sources and the third plurality of light detectors remain affixed to the third position during steps (b), (d), (f), and (h), and
wherein the fourth plurality of light sources and the fourth plurality of light detectors remain affixed to the fourth position during steps (b), (d), (f), and (h).

### Claim 12 (depends on 11)

The method of claim 11, wherein the first angiosome corresponds to a posterior tibial artery, the second angiosome corresponds to a lateral plantar artery, and the third angiosome corresponds to at least one of an anterior tibial artery and a dorsalis pedis artery.

### Claim 13 (depends on 12)

The method of claim 12, wherein the fourth angiosome corresponds to a medial plantar artery.

### Claim 14 (depends on 13)

The method of claim 13, wherein steps (b), (d), (f), and (h) are each performed at a first time during which a pressure cuff is not inflated, and further comprising the step of repeating steps (b), (d), (f), and (h) at a second time during which the pressure cuff is inflated.