IP Library Granted Patent US 12,376,768
Granted Patent B2
US 12,376,768 · App. 18/592,678 · Granted Aug 5, 2025

System and method for non-invasive monitoring of hemoglobin

Inventor: Rodolphe Katra (Blaine, MN)
Assignee: Medtronic Monitoring, Inc.
A61B5/14546A61B5/0071A61B5/02028A61B5/1455A61B5/14551A61B5/0082A61B5/6838A61B2562/0233
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,376,768
App. No.
18/592,678
Granted
Aug 5, 2025
Kind
B2
Abstract

A method of non-invasively monitoring hemoglobin concentration includes providing incident light to patient tissue at a first excitation wavelength. The method further includes monitoring a first emission response at a first emission wavelength, wherein the first emission wavelength is selected to correspond with a maximum of the emission response, and monitoring a second emission response at a second emission wavelength, wherein the second emission wavelength is selected to correspond with a minimum of the emission response. A hemoglobin concentration is calculated based on a ratio of the first emission response to the second emission response.

Claims (49)

1. A system comprising:

a medical device comprising:

one or more light sources configured to provide incident light to a patient at a first excitation wavelength and a second excitation wavelength; and

a photodetector configured to:

monitor emissions in response to the first excitation wavelength at an emission wavelength; and

monitor emissions in response to the second excitation wavelength at the emission wavelength; and

one or more processors configured to determine a physiological parameter based on a ratio of emissions at the emission wavelength monitored in response to the first excitation wavelength and emissions at the emission wavelength monitored in response to the second excitation wavelength.

2. The system of claim 1 , wherein the physiological parameter is a blood protein measurement.

3. The system of claim 1 , wherein the physiological parameter is a fluid measurement.

4. The system of claim 1 , wherein the physiological parameter is a component concentration measurement.

5. The system of claim 1 , wherein the physiological parameter is a blood measurement.

6. The system of claim 1 , wherein the physiological parameter is a protein measurement.

7. The system of claim 1 , wherein the physiological parameter is a photo-active molecule measurement.

8. The system of claim 1 , wherein the emission wavelength is configured to detect the physiological parameter.

9. The system of claim 1 , wherein the one or more processors are configured to:

determine that the physiological parameter has fallen below a threshold value; and

generate an alert in response to the determination that the physiological parameter has fallen below the threshold value.

10. The system of claim 9 , wherein the alert indicates a change in a patient condition.

11. The system of claim 1 , wherein the one or more processors are configured to:

determine a plurality of measurements of the physiological parameter over time during a monitoring period based on a plurality of ratios of emissions at the emission wavelength monitored in response to the first excitation wavelength and emissions at the emission wavelength monitored in response to the second excitation wavelength at respective times during the monitoring period; and

provide an output indicating a trend in physiological parameter measurements over the monitoring period.

12. The system of claim 1 ,

wherein the physiological parameter comprises a first physiological parameter,

wherein the medical device comprises one or more sensors configured to sense one or more additional physiological parameters comprising one or more of an electrocardiogram (ECG) signal, respiration rate, bio-impedance level, activity level, posture, or temperature of the patient, and

wherein the one or more processors are configured to determine a patient condition based on the first physiological parameter and the one or more additional physiological parameters comprising one or more of the ECG signal, respiration rate, bio-impedance level, activity level, posture, or temperature.

13. The system of claim 1 , wherein the medical device is configured for implantation within the patient.

14. A method performed by a medical device comprising processing circuitry and being configured to determine a physiological parameter of a patient, the method comprising:

providing incident light, by one or more light sources of the medical device, to the patient at a first excitation wavelength;

monitoring emissions, by one or more photodetectors of the medical device, in response to the first excitation wavelength at an emission wavelength;

providing incident light, by the one or more light sources, to the patient at a second excitation wavelength;

monitoring emissions, by the one or more photodetectors, in response to the second excitation wavelength at the emission wavelength; and

determining, by the processing circuitry, the physiological parameter based on a ratio of emissions at the emission wavelength monitored in response to the first excitation wavelength and emissions at the emission wavelength monitored in response to the second excitation wavelength.

15. The method of claim 14 , wherein the physiological parameter is a blood protein measurement.

16. The method of claim 14 , wherein the physiological parameter is a fluid measurement.

17. The method of claim 14 , wherein the physiological parameter is a component concentration measurement.

18. The method of claim 14 , wherein the physiological parameter is a blood measurement.

19. The method of claim 14 , wherein the physiological parameter is a protein measurement.

20. The method of claim 14 , wherein the physiological parameter is a photo-active molecule measurement.

21. The method of claim 14 , wherein the emission wavelength is configured to detect the physiological parameter.

22. The method of claim 14 , further comprising:

determining, by the processing circuitry, that the physiological parameter has fallen below a threshold value; and

generating, by the processing circuitry, an alert in response to the determination that the physiological parameter has fallen below the threshold value.

23. The method of claim 14 , wherein generating the alert comprises generating an alert of a change in a patient condition.

24. The method of claim 14 , wherein determining the physiological parameter comprises:

determining a plurality of measurements of the physiological parameter over time during a monitoring period based on a plurality of ratios of emissions at the emission wavelength monitored in response to the first excitation wavelength and emissions at the emission wavelength monitored in response to the second excitation wavelength at respective times during the monitoring period; and

providing an output, by the processing circuitry, indicating a trend in the physiological parameter over the monitoring period.

25. The method of claim 14 , wherein the physiological parameter comprises a first physiological parameter, the method further comprising:

sensing, by the medical device, one or more additional physiological parameters comprising one or more of an electrocardiogram (ECG) signal, respiration rate, bio-impedance level, activity level, posture, or temperature of the patient; and

determining, by the processing circuitry, a patient condition based on the first physiological parameter and the one or more additional physiological parameters comprising one of more of the ECG signal, respiration rate, bio-impedance level, activity level, posture, or temperature.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2024
From: KATRA, RODOLPHE
To: MEDTRONIC MONITORING, INC.
Reel/Frame 066613/0110 →
Continuity (3)
Continuation 17352649 · Jun 21, 2021
Continuation 15866036 · Jan 9, 2018
Related Publication 20240197214A1 · Jun 20, 2024
References Cited (102)
US 5372136A · Steuer et al. · 1994 [cited by applicant]
US 5377674A · Kuestner et al. · 1995 [cited by applicant]
US 5377675A · Ruskewicz et al. · 1995 [cited by applicant]
US 5551422A · Simonsen et al. · 1996 [cited by applicant]
US 5692503A · Kuestner et al. · 1997 [cited by applicant]
US 5692504A · Essenpreis et al. · 1997 [cited by applicant]
US 6064474A · Lee et al. · 2000 [cited by applicant]
US 6526298B1 · Khalil · 2003 [cited by applicant]
US 6606509B2 · Schmitt · 2003 [cited by applicant]
US 6728560B2 · Kollias et al. · 2004 [cited by applicant]
US 7139598B2 · Hull et al. · 2006 [cited by applicant]
US 8078243B2 · Ediger et al. · 2011 [cited by applicant]
US 8121671B2 · Hull et al. · 2012 [cited by applicant]
US 8131332B2 · Maynard et al. · 2012 [cited by applicant]
US 8172459B2 · Abreu · 2012 [cited by applicant]
US 8238993B2 · Maynard et al. · 2012 [cited by applicant]
US 8320981B1 · Mayer et al. · 2012 [cited by applicant]
US 8346332B2 · Kuhn et al. · 2013 [cited by applicant]
US 8480581B2 · Zhang et al. · 2013 [cited by applicant]
US 8571620B2 · Cinbis et al. · 2013 [cited by applicant]
US 8676283B2 · Matter et al. · 2014 [cited by applicant]
US 11039768B2 · Katra · 2021 [cited by applicant]
US 11051727B2 · Katra · 2021 [cited by applicant]
US 11154224B2 · Katra · 2021 [cited by applicant]
US 11918351B2 · Katra · 2024 [cited by applicant]
US 20020038079A1 · Steuer et al. · 2002 [cited by applicant]
US 20020082489A1 · Casciani et al. · 2002 [cited by applicant]
US 20020165439A1 · Schmitt · 2002 [cited by applicant]
US 20030009090A1 · Jeon et al. · 2003 [cited by applicant]
US 20030018241A1 · Mannheimer · 2003 [cited by applicant]
US 20040225207A1 · Bae et al. · 2004 [cited by applicant]
US 20060195022A1 · Trepagnier et al. · 2006 [cited by applicant]
US 20070156036A1 · Pilon · 2007 [cited by applicant]
US 20080214911A1 · Forstner et al. · 2008 [cited by applicant]
US 20090118666A1 · Blomqvist et al. · 2009 [cited by applicant]
US 20100099964A1 · O'Reilly et al. · 2010 [cited by applicant]
US 20100110416A1 · Barrett et al. · 2010 [cited by applicant]
US 20100185252A1 · Bjorling et al. · 2010 [cited by applicant]
US 20100249865A1 · Zhang et al. · 2010 [cited by applicant]
US 20100268090A1 · Rubinstein et al. · 2010 [cited by applicant]
US 20100280499A1 · Yodfat et al. · 2010 [cited by applicant]
US 20100298675A1 · Al-Ali et al. · 2010 [cited by applicant]
US 20120277546A1 · Soykan et al. · 2012 [cited by applicant]
US 20130178724A1 · Ting et al. · 2013 [cited by applicant]
US 20130217984A1 · Graaff et al. · 2013 [cited by applicant]
US 20150073243A1 · Taub et al. · 2015 [cited by applicant]
US 20150201839A1 · Kang et al. · 2015 [cited by applicant]
US 20150245799A1 · Gretz et al. · 2015 [cited by applicant]
US 20160061810A1 · Kim et al. · 2016 [cited by applicant]
US 20160367188A1 · Malik et al. · 2016 [cited by applicant]
US 20160371452A1 · Landrum et al. · 2016 [cited by applicant]
US 20190209055A1 · Katra · 2019 [cited by applicant]
US 20190209060A1 · Katra · 2019 [cited by applicant]
US 20190209061A1 · Katra · 2019 [cited by applicant]
US 20210321912A1 · Katra · 2021 [cited by applicant]
CN 103140169A · 2013 [cited by applicant]
WO 9313706A1 · 1993 [cited by applicant]
WO 0122869A1 · 2001 [cited by applicant]
WO 2003077761A1 · 2003 [cited by applicant]
WO 2011159148A2 · 2011 [cited by applicant]
WO 2012005696A1 · 2012 [cited by applicant]
WO 2012105696A1 · 2012 [cited by applicant]
Office Action from U.S. Appl. No. 17/452,190 dated Jul. 15, 2024, 18 pp. [cited by applicant]
Notice of Allowance from U.S. Appl. No. 17/452,190 dated Dec. 5, 2024, 14 pp. [cited by applicant]
Response to Office Action dated Jul. 15, 2024 from U.S. Appl. No. 17/452,190 filed Oct. 2, 2024, 12 pp. [cited by applicant]
Notice of Allowance from U.S. Appl. No. 17/365,719 dated Jun. 14, 2024, 5 pp. [cited by applicant]
Response to Final Office Action dated Mar. 29, 2024 from U.S. Appl. No. 17/365,719, filed May 28, 2024, 9 pp. [cited by applicant]
Advisory Action from U.S. Appl. No. 17/452,190 dated Jun. 13, 2024, 3 pp. [cited by applicant]
Response to Final Office Action dated Apr. 26, 2024 from U.S. Appl. No. 17/452,190 filed Jun. 3, 2024, 16 pp. [cited by applicant]
Anand et al., “Anemia and Change in Hemoglobin Over Time Related to Mortality and Morbidity in Patients With Chronic Heart Failure”, Results From Val-HeFT., vol. 112, No. 8, Aug. 23, 2005, pp. 1121-1127. [cited by applicant]
Blackwell et al., “In Vivo Time-Resolved Autoftuorescense Measurements to Test for Glycation of Human Skin”, Journal of Biomedical Optics, vol. 13, No. 1, Jan.-Feb. 2008, 15 pp. [cited by applicant]
Carneiro, “Haemoglobin and Haematocrit: is the Threefold Conversion Valid for Assessing Anaemia in Malariaendemic Settings”, Malaria Journal, vol. 6, No. 67, May 22, 2007, 5 pp. [cited by applicant]
Ciobanu et al., “Fiuorophores Advanced Glycation End Products (AGEs)-to-NADH Ratio is Predictor for Diabetic Chronic Kidney and Cardiovascular Disease”, Journal of Diabetes Complications, vol. 29, No. 7, Sep.-Oct. 2015,… [cited by applicant]
De Den Us et al., “Temporal Variations in Hematocrit Values in Patients with Left Ventricular Dysfunction: Relationship with Cause-Specific Mortality and Morbidity and Optimal Monitoring-Further Insights from SOLVD”, Ca… [cited by applicant]
Ediger et al., “Noninvasive Optical Detection of Impaired Glucose Tolderance: A Comparison Against FPG and A1C”, 62, Review of Endocrinology, Jun. 2007. [cited by applicant]
Examination Report from counterpart European Application No. 19706737.4 dated Nov. 24, 2021, 6 pp. [cited by applicant]
First Office Action and Search Report from counterpart Chinese Application No. 201980007665.6 dated Nov. 23, 2023, 8 pp. Translation not available. [cited by applicant]
Hartog, et al., “Advanced Glycation End-Products (AGEs) and Hearth Failure: Pathophysiology and Clinical Implications”, European Journal of Heart Failure, Dec. 2007, pp. 1146-1155. [cited by applicant]
Horecker, “The Absorption Spectra of Hemoglobin and its Deriavitives in the Visible and Near Ifra-Red Regions,” Journal of Biological Chemistry, vol. 148, No. 1, Apr. 1, 1943, pp. 173-183. [cited by applicant]
International Search Report and Written Opinion of International Application No. PCT/IB2019/050235, mailed Apr. 26, 2019, 13 pp. [cited by applicant]
Jeon, et al., “Noninvasive Total Hemoglobin Measurement”, Journal of Biomedical Optics, vol. 7, No. 1, Jan. 2002, pp. 45-50. [cited by applicant]
Li et al., “Advanced Glycation End Products Bisphasically Modulate Bone Resorption in Osteoclast-Like Cells”, American Journal of Physiology, Endocrinology, and Metabolism, vol. 310, Mar. 1, 2016, pp. E355-E366. [cited by applicant]
Lown Des, “Blood interference in fluorescence spectrum- Experiment, analysis and comparison with intra-operative measurements on brain tumor”, Linkoping University, Jul. 9, 2010, 42 pages. [cited by applicant]
McMurdy, et al., “Noninvasive Optical, Electrical, and Acoustic Methods of Total Hemoglobin Determination,” Clinical Chemistry, vol. 54, No. 2, Feb. 2008, pp. 264-272. [cited by applicant]
Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, or the Declaration for PCT/IB2019/050235 mailed Apr. 26, 2019. [cited by applicant]
Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, or the Declaration for PCT/IB2019/050236 mailed Apr. 26, 2019. [cited by applicant]
Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, or the Declaration for PCT/IB2019/050238 mailed Jun. 26, 2019. [cited by applicant]
Pandey, et al., “Emerging Trends in Optical Sensing of Glycemic Markers for Diabetes Monitoring”, Trends in Analytical Chemistry, vol. 64, Jan. 1, 2015, pp. 100-108. [cited by applicant]
Prosecution History from U.S. Appl. No. 15/866,036, dated Jul. 2, 2020 through May 12, 2021, 44 pp. [cited by applicant]
Prosecution History from U.S. Appl. No. 15/866,118, now issued U.S. Pat. No. 11,154,224, dated Jul. 30, 2020 through Oct. 1, 2021, 73 pp. [cited by applicant]
Prosecution History from U.S. Appl. No. 15/866, 160, dated Jun. 29, 2020 through May 12, 2021, 29 pp. [cited by applicant]
Prosecution History from U.S. Appl. No. 17/352,649, now issued U.S. Pat. No. 11,918,351, dated Dec. 15, 2022 through Jan. 31, 2024, 40 pp. [cited by applicant]
Prosecution History from U.S. Appl. No. 17/365,719, dated Dec. 15, 2022 through Mar. 4, 2024, 26 pp. [cited by applicant]
Prosecution History from U.S. Appl. No. 17/452,190, dated Aug. 9, 2022 through Dec. 19, 2023, 24 pp. [cited by applicant]
Rabe, et al., “Measurement of Transcutaneous Hemoglobin Concentration by Noninvasive White-Light Spectroscopy in Infants”, Pediatrics, vol. 116, No. 4, Oct. 2005, pp. 841-843. [cited by applicant]
Response to Rule 161 and 162 dated Aug. 18, 2020, from counterpart European Application No. 19706737.4, filed Feb. 3, 2021, 19 pp. [cited by applicant]
U.S. Appl. No. 17/452,190, filed Oct. 25, 2021, naming inventors Katra. [cited by applicant]
Wong et al., “Augmentation of the Neutrophil Respitory Burst Through the Action of Advanced Glycation End Products”, Diabetes, vol. 51, No. 9, Sep. 2002, pp. 2846-2853. [cited by applicant]
Final Office Action from U.S. Appl. No. 17/365,719 dated Mar. 29, 2024, 11 pp. [cited by applicant]
Final Office Action from U.S. Appl. No. 17/452,190 dated Apr. 26, 2024, 18 pp. [cited by applicant]
Response to Office Action dated Dec. 19, 2023 from U.S. Appl. No. 17/452,190 filed Mar. 19, 2024, 13 pp. [cited by applicant]
Response to Office Action dated Nov. 23, 2023, from counterpart Chinese Application No. 201980007665.6 filed Apr. 3, 2024, 20 pp. Partial translation provided. [cited by applicant]