Granted Patent B2

US 12,444,050 · App. 18/620,830 · Granted Oct 14, 2025

Inventors: Wensheng Fan (Plano, TX); John Michael DiMaio (Dallas, TX); Jeffrey E. Thatcher (Irving, TX); Peiran Quan (Dallas, TX); Faliu Yi (Allen, TX); Kevin Plant (Dallas, TX); Ronald Baxter (Grand Prairie, TX); Brian McCall (Dallas, TX); Zhicun Gao (Plano, TX); Jason Dwight (Dallas, TX)

Assignee: Spectral MD, Inc.

G06T7/0012A61B5/445A61B5/7275G06T7/11G16H30/40G16H50/30A61B5/0077G06T2207/20081G06T2207/30088G06T2207/30096

Abstract

Claims (50)

1. A system for assessing or predicting wound healing, the system comprising:

an application executable by a mobile computing device, the mobile computing device comprising one or more processors in communication with at least one light detection element, the one or more processors configured with processor-executable instructions included in the application to perform operations comprising:

receiving at least one signal from the light detection element representing light of at least a first wavelength reflected from a tissue region comprising a wound or portion thereof;

generating, based on the at least one signal, an image having a plurality of pixels depicting the tissue region;

determining, based on the signal, a reflectance intensity value at the first wavelength for each pixel of at least a subset of the plurality of pixels;

determining one or more quantitative features of the subset of the plurality of pixels based on the reflectance intensity values of each pixel of the subset; and

causing generation, using one or more machine learning algorithms, of at least one scalar value based on the one or more quantitative features of the subset of the plurality of pixels, the at least one scalar value corresponding to a predicted amount of healing of the wound or portion thereof over a predetermined time interval following generation of the image.

2. The system of claim 1 , wherein the operations further comprise determining the predicted amount of healing of the wound or portion thereof over the predetermined time interval.

3. The system of claim 1 , wherein the predicted amount of healing is a predicted percent area reduction of the wound or portion thereof.

4. The system of claim 1 , wherein the predetermined time interval is 30 days.

5. The system of claim 1 , wherein the operations further comprise identifying at least one patient health metric value corresponding to a patient having the tissue region, and wherein the at least one scalar value is generated based on the one or more quantitative features of the subset of the plurality of pixels and on the at least one patient health metric value.

6. The system of claim 5 , wherein the at least one patient health metric value comprises at least one variable selected from demographic variables, compliance variables, endocrine variables, cardiovascular variables, musculoskeletal variables, nutrition variables, infectious disease variables, renal variables, obstetrics or gynecology variables, drug use variables, other disease variables, or laboratory values.

7. The system of claim 5 , wherein the at least one patient health metric value comprises at least one feature selected from the group consisting of an age of the patient, a level of chronic kidney disease of the patient, a length of the wound or portion thereof on a day when the image is generated, and a width of the wound or portion thereof on the day when the image is generated.

8. The system of claim 1 , wherein the first wavelength is within the range of 620 nm±20 nm, 660 nm±20 nm, or 420 nm±20 nm, and wherein the one or more machine learning algorithms comprise a random forest ensemble.

9. The system of claim 1 , wherein the first wavelength is within the range of 726 nm±41 nm, 855 nm±30 nm, 525 nm±35 nm, 581 nm±20 nm, or 820 nm±20 nm, and wherein the one or more machine learning algorithms comprise an ensemble of classifiers.

10. The system of claim 1 , wherein the operations further comprise:

automatically causing the plurality of pixels of the image to be segmented into wound pixels and non-wound pixels; and

selecting the subset of the plurality of pixels to comprise the wound pixels.

11. The system of claim 10 , wherein the plurality of pixels are automatically segmented using a segmentation algorithm comprising at least one of a U-Net comprising a plurality of convolutional layers and a SegNet comprising a plurality of convolutional layers.

12. The system of claim 1 , wherein the one or more quantitative features of the subset of the plurality of pixels are selected from the group consisting of a mean of the reflectance intensity values of the pixels of the subset, a standard deviation of the reflectance intensity values of the pixels of the subset, and a median reflectance intensity value of the pixels of the subset.

13. The system of claim 1 , wherein the operations further comprise:

individually applying a plurality of filter kernels to the image by convolution to generate a plurality of image transformations;

constructing a 3D matrix from the plurality of image transformations; and

determining one or more quantitative features of the 3D matrix, wherein the at least one scalar value is generated based on the one or more quantitative features of the subset of the plurality of pixels and on the one or more quantitative features of the 3D matrix.

14. The system of claim 13 , wherein the one or more quantitative features of the 3D matrix are selected from the group consisting of a mean of the values of the 3D matrix, a standard deviation of the values of the 3D matrix, a median value of the 3D matrix, and a product of the mean and the median of the 3D matrix.

15. The system of claim 14 , wherein the at least one scalar value is generated based on the mean of the reflectance intensity values of the pixels of the subset, the standard deviation of the reflectance intensity values of the pixels of the subset, the median reflectance intensity value of the pixels of the subset, the mean of the values of the 3D matrix, the standard deviation of the values of the 3D matrix, and the median value of the 3D matrix.

16. The system of claim 1 , wherein the operations further comprise:

receiving a second signal from the at least one light detection element, the second signal representing light of a second wavelength reflected from the tissue region;

determining, based on the second signal, a reflectance intensity value at the second wavelength for each pixel of at least the subset of the plurality of pixels; and

determining one or more additional quantitative features of the subset of the plurality of pixels based on the reflectance intensity values of each pixel at the second wavelength;

wherein the at least one scalar value is generated based at least in part on the one or more additional quantitative features of the subset of the plurality of pixels.

17. The system of claim 1 , wherein the at least one scalar value is generated on a same day as a beginning of the predetermined time interval.

18. The system of claim 1 , wherein the operations further comprise:

receiving an indication of an actual amount of healing of the wound or portion thereof over the predetermined time interval, the indication determined based on a measurement of one or more dimensions of the wound or portion thereof after the predetermined time interval has elapsed following the determination of the predicted amount of healing of the wound or portion thereof; and

causing at least one machine learning algorithm of the one or more machine learning algorithms to be updated by providing at least the image and the actual amount of healing of the wound or portion thereof as training data.

19. The system of claim 1 , wherein the operations further comprise selecting, prior to an end of the predetermined time interval, between a standard wound care therapy and an advanced wound care therapy based at least in part on the predicted amount of healing of the wound or portion thereof.

20. The system of claim 19 , wherein selecting between the standard wound care therapy and the advanced wound care therapy comprises:

when the predicted amount of healing indicates that the wound or portion thereof will heal or close by greater than 50% in 30 days, indicating one or more standard therapies selected from improving nutritional status, debridement to remove devitalized tissue, maintenance of granulation tissue with a dressing, therapy to address any infection that may be present, addressing a deficiency in vascular perfusion to an extremity comprising the wound or portion thereof, offloading of pressure from the wound or portion thereof, or glucose regulation; and

when the predicted amount of healing indicates that the wound or portion thereof will not heal or close by greater than 50% in 30 days, indicating one or more advanced care therapies selected from the group consisting of hyperbaric oxygen therapy, negative-pressure wound therapy, bioengineered skin substitutes, synthetic growth factors, extracellular matrix proteins, matrix metalloproteinase modulators, and electrical stimulation therapy.

21. The system of claim 1 , wherein the mobile computing device comprises a smartphone or a tablet.

22. A method for assessing or predicting wound healing, the method comprising:

under control of one or more processors of a mobile computing device:

receiving at least one signal from a light detection element of the mobile computing device, the at least one signal representing light of at least a first wavelength reflected from a tissue region comprising a wound or portion thereof;

generating, based on the at least one signal, an image having a plurality of pixels depicting the tissue region;

determining, based on the signal, a reflectance intensity value at the first wavelength for each pixel of at least a subset of the plurality of pixels;

determining one or more quantitative features of the subset of the plurality of pixels based on the reflectance intensity values of each pixel of the subset; and

causing generation, using one or more machine learning algorithms, of at least one scalar value based on the one or more quantitative features of the subset of the plurality of pixels, the at least one scalar value corresponding to a predicted amount of healing of the wound or portion thereof over a predetermined time interval following generation of the image.

23. The method of claim 22 , further comprising determining the predicted amount of healing of the wound or portion thereof over the predetermined time interval.

24. The method of claim 22 , wherein the amount of healing is a predicted percent area reduction of the wound or portion thereof.

25. The method of claim 22 , wherein the mobile device comprises a smartphone or a tablet.

Assignments (2)

Continuity (8)

References Cited (391)