IP Library Granted Patent US 11,564,619
Granted Patent B2
US 11,564,619 · App. 16/224,590 · Granted Jan 31, 2023

Magnetic resonance spectroscopy system and method for diagnosing pain or infection associated with propionic acid

Inventors: Jeffrey C. Lotz (Oakland, CA); James Clayton Peacock, III (Redwood City, CA); David S. Bradford (Sausalito, CA); Stefan Dudli (Bern, CH); Sergey G. Magnitsky (Oakland, CA)
Assignees: ACLARION, INC.; THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
A61B5/4514A61B5/055A61B5/412A61B5/4566G01R33/46G01R33/465G01R33/483G01R33/485G01R33/4828G01R33/5608
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Quick Facts
Patent No.
US 11,564,619
App. No.
16/224,590
Granted
Jan 31, 2023
Kind
B2
Abstract

An MR Spectroscopy (MRS) system and approach is provided for measuring spectral information corresponding with propionic acid (PA), either alone or in combination with other measurements corresponding with other chemicals, to diagnose and/or monitor at least one of bacterial infection, such as associated with P. acnes , or conditions related thereto such as nociceptive pain associated with tissue acidity. An interfacing DDD-MRS signal processor receives output signals to produce a post-processed spectrum, with spectral regions corresponding with certain chemicals, including PA, then measured as biomarkers. A diagnostic processor derives a diagnostic value for each disc, and performs certain normalizations, based upon ratios of the spectral regions related to chemicals implicated in degenerative painful tissue pathology, such as PA and hypoxia markers of lactic acid (LA) and alanine (AL), and structural chemicals of proteoglycan (PG) and collagen or carbohydrate (CA).

Claims (57)

1. A diagnostic system for providing diagnostic information for diagnosing whether a region of interest (ROI) in an intervertebral disc in a spine of a patient is infected with bacteria, the diagnostic system comprising:

a magnetic resonance (MR) system configured to:

generate and acquire a magnetic resonance spectroscopy (MRS) spectral acquisition series of data for a voxel located within the region of interest (ROI) using an MRS pulse sequence;

obtain one or more MRI images of a region of the spine associated with the intervertebral disc;

an MRS signal processor configured to process the MRS spectral acquisition series of data to produce a processed MRS spectrum; and

a diagnostic processor configured to:

analyze a spectral peak region of the processed MRS spectrum that corresponds with propionic acid (PA) and that includes at least a portion below a range associated with lactic acid (LA) to identify a spectral feature that comprises a spectral peak;

calculate a measurement for the spectral feature;

process the one or more MRI images to extract an MRI signature of Modic change (MC) in the spine; and

generate the diagnostic information for diagnosing whether the region of interest (ROI) in the intervertebral disc is infected with bacteria using the calculated measurement and the MRI signature.

2. The system of claim 1 , wherein the bacteria is Propionibacteria acnes ( P.acnes ).

3. The system of claim 1 , wherein the diagnostic processor is configured to calculate a diagnostic value that is indicative of a presence or absence of bacterial infection based at least in part on a calculated ratio between (i) the calculated measurement corresponding with PA, and (ii) at least a measured second calculated measurement for at least a second feature along at least a second spectral region of the processed MRS spectrum that corresponds with at least one of proteoglycan (PG), lactate (LA), alanine (AL), or carbohydrate (CA) chemicals.

4. The system of claim 1 , wherein the diagnostic processor is configured to determine the diagnostic information based at least in part upon a second calculated measurement derived from information extracted from a second ROI in a second intervertebral disc in the spine, wherein the second calculated measurement corresponds with at least one chemical factor in the second ROI comprising propionic acid (PA).

5. A method for providing diagnostic information for diagnosing whether a region of interest (ROI) in an intervertebral disc in a spine of a patient is infected with bacteria, the method comprising:

generating and acquiring a magnetic resonance spectroscopy (MRS) spectral acquisition series of data for a voxel located within the region of interest (ROI) in the intervertebral disc using an MRS system with an MRS scanner comprising a magnet and operated according to an MRS pulse sequence to generate the series of data and a detector assembly configured for receiving the series of data;

signal processing the MRS spectral acquisition series of data to produce a processed MRS spectrum;

analyzing a spectral peak region of the processed MRS spectrum that corresponds at least in part with propionic acid (PA) and that includes at least a portion below a range associated with lactic acid (LA) to identify a spectral feature that comprises a spectral peak;

calculating a measurement for the spectral feature; and

generating the diagnostic information for diagnosing whether the region of interest (ROI) in the intervertebral disc is infected with bacteria using the calculated measurement.

6. The method of claim 5 , further comprising:

obtaining one or more MRI images of a region of the spine associated with the intervertebral disc; and

extract a MRI signature associated with Modic change (MC) in the spine of the patient from the one or more MRI images, wherein the diagnostic information is generated using the MRI signature.

7. The method of claim 5 , wherein the bacteria is Propionibacteria acnes ( P.acnes ).

8. The method of claim 5 , further comprising:

generating and acquiring a second MRS spectral acquisition series of data for a second voxel located within a second region of interest (ROI) in a second intervertebral disc using the MRS system;

signal processing the second MRS spectral acquisition series of data to produce a second processed MRS spectrum;

identifying a spectral feature along a spectral peak region of the second processed MRS spectrum that corresponds at least in part with propionic acid (PA);

calculating a measurement for the spectral feature to produce a second calculated measurement associated with the second ROI; and

generating the diagnostic information using the second calculated measurement.

9. The method of claim 8 , further comprising:

determining a first score for the ROI based at least in part on the calculated measurement;

determine a second score for the second ROI based at least in part on the second calculated measurement; and

compare the first score to the second score, wherein the diagnostic information is based at least in part on the comparison.

10. The method of claim 5 , wherein the signal processing, the identifying of the spectral feature, the calculating of the measurement, and the generating of the diagnostic information is performed by at least one computer processor.

11. The method of claim 5 , further comprising preparing an antibiotic treatment for administration to the patient in response to the diagnostic information.

12. The method of claim 5 , further comprising calculating at least a second measurement for at least a second spectral feature along at least a second respective spectral peak region of the processed MRS spectrum associated with at least one of proteoglycan (PG), carbohydrate (CA), lactate (LA), or alanine (AL) chemicals, and wherein the diagnostic information is further based at least in part on the second calculated measurement.

13. The method of claim 12 , further comprising calculating a diagnostic value derived at least in part on a ratio between the calculated measurement and the second calculated measurement.

14. A diagnostic system for providing diagnostic information for diagnosing whether a region of interest (ROI) in an intervertebral disc in a spine of a patient is infected with bacteria, the diagnostic system comprising:

a magnetic resonance spectroscopy (MRS) signal processor configured to receive a multi-frame MRS spectral acquisition series generated for a voxel principally located within the region of interest (ROI) in the intervertebral disc via an MRS pulse sequence, the MRS signal processor configured to process the MRS spectral acquisition series to produce a processed MRS spectrum;

an MRS diagnostic processor configured to:

analyze a spectral peak region of the processed MRS spectrum that comprises a region corresponding at least in part with propionic acid (PA) and that includes at least a portion below a range associated with lactic acid (LA) to identify a spectral feature that comprises a spectral peak;

calculate a measurement for the spectral feature; and

generate the diagnostic information for diagnosing whether the region of interest (ROI) in the intervertebral disc is infected with bacteria using the calculated measurement;

wherein each of the MRS signal processor and MRS diagnostic processor comprises at least one of:

(a) at least one computer processor, and

(b) software provided in computer-readable non-transitory storage and that is configured to be run by at least one computer processor.

15. The system of claim 14 , further comprising a magnetic resonance (MR) system that is configured to produce one or more MRI images of the spine, and wherein the diagnostic processor is configured to generate the diagnostic information based at least in part on an MRI signature of modic change (MC) in the spine of the patient.

16. The system of claim 14 , wherein the bacteria is Propionibacteria acnes ( P.acnes ).

17. The system of claim 14 , further comprising an MRS system with an MRS scanner comprising a magnet and operable according to the MRS pulse sequence to generate the MRS spectral acquisition series and a detector assembly configured for receiving the MRS spectral acquisition series.

18. The system of claim 14 , wherein the spectral peak region comprises a combined spectral peak region corresponding with both propionic acid (PA) and lactate (LA) (LAPA).

19. The system of claim 14 , wherein the spectral peak region comprises a combined spectral peak region corresponding with each of propionic acid (PA), lactate (LA), and alanine (AL) (ALPA).

20. The system of claim 14 , wherein the diagnostic processor is configured to calculate a diagnostic value that is indicative of a presence or absence of bacterial infection based at least in part on a combination of (i) the calculated measurement corresponding with PA, and (ii) at least a measured second calculated measurement for at least a second feature along at least a second spectral region of the processed MRS spectrum that corresponds with at least one of proteoglycan (PG), lactate (LA), alanine (AL), or carbohydrate (CA) chemicals.

21. The system of claim 14 , wherein the diagnostic processor is configured to calculate a diagnostic value derived from at least one calculated ratio between at least two calculated measurements for at least two respective features along at least two respective spectral peak regions of the processed MRS spectrum and associated with at least two chemicals in the ROI, wherein at least one said chemical comprises PA.

22. The system of claim 14 , wherein the diagnostic information is further based at least in part upon a contained volume of the voxel.

23. The system of claim 14 , wherein the calculated measurement is adjusted by a subject-related adjustment factor associated with a known value or condition of a subject-dependent variable comprising at least one of height, weight, percentage body fat, body mass index (BMI), and gender.

24. The system of claim 14 , wherein the diagnostic processor is configured to determine the diagnostic information based at least in part upon a second calculated measurement derived from information extracted from a second ROI in a second intervertebral disc in the spine, wherein the second calculated measurement corresponds with at least one chemical factor in the second ROI comprising propionic acid (PA).

25. The system of claim 24 , wherein the diagnostic processor is configured to calculate a first score for the ROI based at least in part on the calculated measurement, to calculate a second score for the second ROI based at least in part on the calculated second measurement, and to determine the diagnostic information based at least in part on the first score and the second score.

Assignments (4)
CHANGE OF NAME Recorded Mar 16, 2022
From: NOCIMED, INC.
To: ACLARION, INC.
Reel/Frame 059374/0491 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 16, 2020
From: BRADFORD, DAVID S.; MAGNITSKY, SERGEY G.; DUDLI, STEFAN; LOTZ, JEFFREY C.
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 053226/0702 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2019
From: PEACOCK, JAMES CLAYTON, III
To: NOCIMED, INC.
Reel/Frame 050958/0478 →
CONFIRMATORY LICENSE Recorded Jul 23, 2019
From: UNIVERSITY OF CALIFORNIA,SAN FRANCISCO
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 049830/0592 →
Continuity (3)
Continuation PCTUS2017038034 · Jun 16, 2017
Provisional Application 62351963 · Jun 19, 2016
Related Publication 20190307393A1 · Oct 10, 2019
Cited By (3)
US 12,239,455 US 12,369,813 US 12,453,487