# US 11,026,582 B2 · OxyVu-1 hyperspectral tissue oxygenation (HTO) measurement system

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,026,582 B2
- Document ID: US11026582B2
- Status: Granted
- Kind: B2
- Application number: 15/676,922
- Filed: 2017-08-14
- Published: 2018-04-05
- Granted: 2021-06-08
- Earliest claimed: 2006-06-30
- Assignees: Hypermed Imaging, Inc.
- Applicants: Hypermed Imaging, Inc.
- Inventors: Svetlana Panasyuk; Jenny Freeman; Kevin Schomacker; Richard Lifsitz
- Web page: https://patentgrep.com/patent/US11026582B2

## CPC

- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/14551: {for measuring blood gases}
- G01J 3/0224: {using polarising or depolarising elements}
- G01J 3/0264: {Electrical interface; User interface}
- G01J 3/0289: {Field-of-view determination; Aiming or pointing of a spectrometer; Adjusting alignment; Encoding angular position; Size of measurement area; Position tracking}
- G01J 3/28: Investigating the spectrum (using colour filters G01J3/51)
- G01J 3/2823: {Imaging spectrometer}
- G01J 3/32: Investigating bands of a spectrum in sequence by a single detector
- G01J 2003/2826: {Multispectral imaging, e.g. filter imaging}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01J: MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY (light sources F21, H01J, H01K, H05B; investigating properties of materials by optical means G01N)

## Abstract

The invention is directed to a hyperspectral/multispectral system referred to as the OxyVu-1 system. The hyperspectral imaging technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the OxyVu-1 system, the spectral analytical methods determined in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HT-Oxy), and deoxyhemoglobin levels (HT-Deoxy). The OxyVu-1 system displays the tissue oxygenation in a two-dimensional, color-coded image. The system contains a system console, a cart, system electronics, CPU, monitor, keyboard, pointing device and printer. The hyperspectral instrument head with support arm contains broadband illuminator, camera and spectral filter for collecting hyperspectral imaging cube. The single use OxyVu Check Pads and Targets are used to perform an instrument check prior to patient measurements. The OxyVu Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.

## Claims

### Claim 1

A non-transitory computer readable storage medium storing one or more programs, the one or more programs comprising instructions which, when executed by an imaging system configured to acquire a plurality of images of a tissue of a subject, cause the imaging system to:
resolve a plurality of absorption signals from the plurality of images,
account for a contribution provided by melanin and losses caused by diffuse scattering in each respective absorption signal in the plurality of absorption signals, wherein the respective contribution provided by melanin and the respective losses provided by diffuse scattering to each respective absorption signal in the plurality of absorption signals are collectively modeled, thereby forming a plurality of corrected absorption signals,
determine a plurality of tissue oxygenation measurements for the tissue based on the plurality of corrected absorption signals, and
form a two-dimensional image of tissue oxygenation of the tissue from the plurality of tissue oxygenation measurements.

### Claim 2 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the plurality of tissue oxygenation measurements comprise: a value for oxyhemoglobin and a value for deoxyhemoglobin.

### Claim 3 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the two-dimensional image of tissue oxygenation comprises a plurality of pixels and for each respective pixel in the plurality of pixels, a corresponding value for oxyhemoglobin and a corresponding value for deoxyhemoglobin.

### Claim 4 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the two-dimensional image of tissue oxygenation is configured to be viewed pixel by pixel, as a region of interest, or for a viewing area.

### Claim 5 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the two-dimensional image has at least 0.1 mm spatial resolution within a field of view.

### Claim 6 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions configure the imaging system to detect a reduced blood flow ischemia state in the subject.

### Claim 7 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions are configured to be executed by the imaging system further comprising a hard disc drive onto which data or displayed information obtained from the system is stored, wherein the hard disk drive is in electrical communication with one or more processing units.

### Claim 8 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions, when executed by the imaging system further comprising a display, cause the imaging system to display the two-dimensional image of tissue oxygenation of the tissue.

### Claim 9 (depends on 8)

The non-transitory computer readable storage medium of claim 8, wherein the instructions cause the system, in response to user selection of a region of the two-dimensional image of tissue oxygenation, to display an average value of a calculated diagnostic feature of the selected region.

### Claim 10 (depends on 9)

The non-transitory computer readable storage medium of claim 9, wherein the calculated diagnostic feature is selected from the group consisting of:
a value for oxyhemoglobin;
a value for deoxyhemoglobin;
a value for percent oxygen saturation;
an automatic ulcer border mapping;
a semiautomatic ulcer border mapping;
a value for ulcer size;
a value for ulcer depth;
an ulcer healing index; and
an ulcer prediction index.

### Claim 11 (depends on 9)

The non-transitory computer readable storage medium of claim 9, wherein the diagnostic feature comprises an ulcer healing index and wherein the ulcer healing index comprises any one or more of the group consisting of:
a comparison of one or more values inside an ulcer to one or more values outside the ulcer;
a comparison of one or more values outside the ulcer to one or more values measured from the subject's forearm;
a comparison of one or more values outside the ulcer to one or more values measured on a previous visit of the subject;
a comparison of one or more values inside or outside the ulcer to one or more pieces of clinical data; and
a comparison of a response of one or more values inside or outside the ulcer to leg dependency, blood pressure cuff induced ischemia, exercise induced ischemia, or administered oxygen.

### Claim 12 (depends on 9)

The non-transitory computer readable storage medium of claim 9, wherein the diagnostic feature comprises an ulcer prediction index and wherein the ulcer prediction index comprises any one or more of the group consisting of:
a comparison of one or more values from a site of interest to one or more values outside the site of interest;
a comparison of one or more values outside the site of interest to one or more values measured from the forearm;
a comparison of one or more values outside the site of interest to one or more values measured on a previous visit of the subject;
a comparison of one or more values inside or outside the site of interest to one or more pieces of clinical data; and
a comparison of one or more values inside or outside the site of interest to leg dependency, blood pressure cuff induced ischemia, exercise induced ischemia, or administered oxygen.

### Claim 13 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions for accounting for background noise cause the imaging system to quantify the contribution provided by melanin and the loss provided by diffuse scattering by fitting a second order polynomial to the plurality of absorption signals for each respective image in the plurality of images of the tissue of the subject.

### Claim 14 (depends on 13)

The non-transitory computer readable storage medium of claim 13, wherein the second order polynomial has the form:
(b2(x,y)λ2+b1(x,y)λ+b0(x,y))
wherein
b0, b1 and b2 are coefficients determined by minimizing the squared difference between the term (b2(x, y)λ2+b1(x, y)λ+b0(x, y)) and the plurality of absorption signals determined for the image acquired at each wavelengths (λ) by the hyperspectral/multispectral imaging camera at coordinates (x, y) of the tissue of the subject.

### Claim 15 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions for accounting for background noise cause the imaging system to subtract the contributions provided by melanin and the losses provided by diffuse scattering from each respective absorption signal AT(λ,x,y) in the plurality of absorption signals to form the plurality of corrected absorption signals AH(κ, x, y) by applying a second order polynomial:
AH(λ,x,y)=AT(λ,x,y)−(b2(x,y)λ2+b1(x,y)λ+b0(x,y))
wherein, b0, b1 and b2 are coefficients, λ is the wavelength of the respective absorption signal and x, y are positional coordinates on the tissue of the subject.

### Claim 16 (depends on 15)

The non-transitory computer readable storage medium of claim 15, wherein each respective absorption signals (AT)(λ,x,y) in the plurality of absorption signals is determined by comparing reflected light from the tissue of the subject to a background illumination signal using the algorithm:
A
T
⁡
(
x
,
y
,
λ
)
=
-
log
10
⁡
(
I
t
⁡
(
x
,
y
,
λ
)
-
B
′
⁡
(
x
,
y
,
λ
)
I
0
⁡
(
x
,
y
,
λ
)
-
B
′
⁡
(
x
,
y
,
λ
)
)
wherein,
It and Io are reflective intensities collected during acquisition of the series of images from the tissue of the subject at (x,y), and
B′ is a background illumination signal recorded with a closed camera aperture.

### Claim 17 (depends on 16)

The non-transitory computer readable storage medium of claim 16, wherein the instructions for determining a plurality of tissue oxygenation measurements cause the imaging system to determine a total hemoglobin level (HT-THb) by calculating the total absorbance of AH in the wavelength region between 530 nm and 590 nm.

### Claim 18 (depends on 1)

The non-transitory computer readable storage medium of claim 1, wherein the instructions for determining a plurality of tissue oxygenation measurements cause the imaging system to determine relative contributions of oxyhemoglobin (oxyHb(λ)) and deoxyhemoglobin (deoxyHb(λ)) to a corrected absorption signal resolved at a wavelength λ at a position (x,y) on the tissue of the subject by fitting the equation:
c3(x,y)×deoxyHb(λ)×K(λ)c2(x,y)×oxyHb(λ)×K(λ)+c1(x,y)×K(λ)+c0(x,y)
to the corrected absorption signal, wherein:
c0, c1, c2 and c3 are coefficients, and
K(Δ)=(λ−500)/300.

### Claim 19 (depends on 18)

The non-transitory computer readable storage medium of claim 18, wherein the instructions for determining a plurality of tissue oxygenation measurements cause the imaging system to determine a percent hemoglobin oxygen saturation HTSat(x,y) using the equation:
HTSat
⁢
⁢
(
x
,
y
)
=
c
2
⁡
(
x
,
y
)
c
2
⁡
(
x
,
y
)
+
c
3
⁡
(
x
,
y
)
×
100
⁢
⁢
%
.

### Claim 20 (depends on 18)

The non-transitory computer readable storage medium of claim 18, wherein the instructions for determining a plurality of tissue oxygenation measurements cause the imaging system to determine approximate levels of oxyhemoglobin HTOxy(x,y) and deoxyhemoglobin HTDeoxy(x,y) for the tissue of the subject using the equations:
HTOxy
⁡
(
x
,
y
)
=
HTSat
⁡
(
x
,
y
)
×
HTTHb
⁡
(
x
,
y
)
100
and
HTDeoxy
⁡
(
x
,
y
)
=
(
HTTHb
⁡
(
x
,
y
)
-
oxyHb
⁡
(
x
,
y
)
)
.