IP Library Granted Patent US 12,419,572
Granted Patent B2
US 12,419,572 · App. 18/921,857 · Granted Sep 23, 2025

Perfusion and oxygenation measurement

Inventors: Martin F. Burns (Los Angeles, CA); Graham O. Ross (Oceanside, CA)
Assignee: BBI Medical Innovations, LLC
A61B5/445A61B5/0064A61B5/0075A61B5/14552A61B5/0261A61B5/447
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Quick Facts
Patent No.
US 12,419,572
App. No.
18/921,857
Granted
Sep 23, 2025
Kind
B2
Abstract

The present disclosure provides methods and apparatus for evaluating the flow of blood in damaged or healing tissue. The present disclosure also provides methods of identifying a patient at the onset of risk of pressure ulcer or at risk of the onset of pressure ulcer, and treating the patient with anatomy-specific clinical intervention selected based on perfusion or blood oxygenation values, or a combination thereof. The present disclosure also provides methods of stratifying groups of patients based on risk of wound development and methods of reducing incidence of tissue damage in a care facility. The present disclosure also provides methods to analyze trends of perfusion or oxygenation measurements to detect tissue damage before it is visible, and methods to compare bisymmetric perfusion values to identify damaged tissue.

Claims (51)

1. A method of assessing a patient, the method comprising the steps of:

performing an initial measurement of a body location selected for monitoring using an apparatus comprising an emitter configured to selectably emit light at one or more wavelengths, wherein the initial measurement comprises measurements of reflected light comprising infrared light or near infrared light;

calculating an initial delta value for the body location from the initial measurement;

determining that there is possible tissue damage at the body location selected for monitoring when the initial delta value is greater than or equal to a first threshold; and

assigning the patient to a risk category selected from a group comprising a plurality of risk categories, wherein the assigning is based partially on the initial delta value, and wherein the group of risk categories comprises a low-risk category, an at-risk category, a high-risk category, and a very-high-risk category.

2. The method of claim 1 , wherein the infrared light comprises light in the wavelength range between 700 nanometers and 1 millimeter.

3. The method of claim 1 , wherein the near infrared light comprises light in the wavelength range between 700 and 900 nanometers.

4. The method of claim 1 , further comprising the step of:

when the initial delta value is less than the first threshold, performing at least one of (i) administering a level N=0 intervention, and (ii) obtaining a subsequent measurement of the body location after a time interval associated with level N=0 transpires.

5. The method of claim 1 , further comprising the step of:

implementing an intervention of level-N when the initial delta value is greater than or equal to the first threshold, wherein the intervention is selected based partially on the body location and partially on the initial delta value, and wherein N is an integer of value 1 or greater.

6. The method of claim 5 , wherein the intervention is selected from a group consisting of: a standard mattress, a high-specification mattress, a low-friction sheet cover, a low-friction padded mattress surface, a silicone pad, a dressing, a heel boot, a barrier cream, a topical cream, a neuro-muscular stimulation, turning the patient at a first interval, and turning the patient at a second interval that is shorter than the first interval.

7. The method of claim 1 , further comprising the steps of:

performing a second measurement of the body location identified as having possible damage in the initial measurement at a first time interval corresponding to an initial level-N intervention;

calculating a second delta value for the body location from the second measurement;

performing measurements of all body locations selected for monitoring at a second time interval, wherein the second time interval is longer than the first time interval; and

calculating delta values for each of the sets of measurements of all body locations.

8. The method of claim 7 , wherein the first time interval and the second time interval are dependent upon the assigned risk category.

9. The method of claim 7 , further comprising the step of:

when the second delta value is less than a second threshold, performing at least one of (i) administering the initial level-N intervention, and (ii) obtaining a subsequent measurement of the body location after the first time interval corresponding to the initial level-N intervention transpires.

10. The method of claim 7 , further comprising the step of:

implementing an intervention of level-M when the second delta value is greater than or equal to a second threshold, wherein M is an integer and M is greater than N.

11. The method of claim 1 , further comprising the steps of:

calculating a prior delta value for a previous measurement of the body location;

performing a measurement of the body location at a first time interval when the prior delta value is greater than or equal to a third threshold; and

performing a measurement of a body location at a second time interval when the prior delta value is greater than or equal to a fourth threshold, wherein the fourth threshold is higher than the third threshold and the second time interval is shorter than the first time interval.

12. The method of claim 1 , wherein:

the step of performing an initial measurement comprises performing an initial risk assessment of the patient, and

the assigning of the risk category is based partially on the results of the initial risk assessment.

13. The method of claim 1 , wherein the initial measurement comprises a first intensity of reflected light at a first wavelength and a second intensity of reflected light at a second wavelength.

14. The method of claim 13 , wherein the first wavelength and the second wavelength comprise the same wavelength of infrared or near infrared light, and wherein the measurements of reflected light at the first wavelength and the second wavelength are at non-overlapping times.

15. A method of managing care of a patient, the method comprising the steps of:

performing an initial evaluation of the patient and initial measurements of all body locations selected for monitoring upon admission using an apparatus comprising an emitter configured to selectably emit light at one or more wavelengths, wherein each of the initial measurements comprises measurements of reflected light comprising infrared light or near infrared light;

calculating an initial delta value for each body location selected for monitoring from the initial measurements;

determining that there is possible tissue damage at the body location selected for monitoring when its respective initial delta value is greater than or equal to a first threshold;

implementing a level-N intervention for each body location having an initial delta value that is greater than or equal to the first threshold; and

obtaining measurements of all body locations at a level-N frequency and calculating new delta values, wherein the intervention level is set to N=1.

16. The method of claim 15 , wherein the infrared light comprises light in the wavelength range between 700 nanometers and 1 millimeter.

17. The method of claim 15 , wherein the near infrared light comprises light in the wavelength range between 700 and 900 nanometers.

18. The method of claim 15 , further comprising the step of:

increasing the level-N intervention to level-N+1, implementing a level-N+1 intervention, and performing a measurement at level-N+1 frequency when any new delta value is greater than or equal to a prior delta value at the same body location.

19. The method of claim 15 , further comprising the step of:

continuing with the level-N intervention and performing a measurement at level-N frequency when all new delta values above the first threshold are less than the respective prior delta value at the same body location.

20. The method of claim 15 , further comprising the step of:

performing a measurement at level-N−1 frequency when all new delta values are less than a second threshold that is lower than the first threshold.

21. The method of claim 15 , wherein the following steps are performed when the patient is to be transferred or discharged:

performing a final set of measurements of all body locations selected for monitoring,

calculating a final set of delta values for each body location scanned, and

documenting the final set of delta values.

22. The method of claim 15 , wherein each of the initial measurements comprises a first intensity of reflected light at a first wavelength and a second intensity of reflected light at a second wavelength.

23. The method of claim 22 , wherein the first wavelength and the second wavelength comprise the same wavelength of infrared or near infrared light, and wherein the measurements of reflected light at the first wavelength and the second wavelength are at non-overlapping times.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2025
From: BRUIN BIOMETRICS LLC
To: BBI MEDICAL INNOVATIONS, LLC
Reel/Frame 069912/0974 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2025
From: ROSS, GRAHAM O.
To: BRUIN BIOMETRICS, LLC
Reel/Frame 069944/0020 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2025
From: BRUIN BIOMETRICS, LLC
To: BBI MEDICAL INNOVATIONS, LLC
Reel/Frame 069944/0028 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2025
From: BURNS, MARTIN F.
To: BRUIN BIOMETRICS, LLC
Reel/Frame 069944/0051 →
Continuity (5)
Continuation 18348442 · Jul 7, 2023
Continuation 16511802 · Jul 15, 2019
Provisional Application 62849700 · May 17, 2019
Provisional Application 62698684 · Jul 16, 2018
Related Publication 20250040871A1 · Feb 6, 2025
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