IP Library › Granted Patent US 12,213,812
Granted Patent B2
US 12,213,812 · App. 18/494,359 · Granted Feb 4, 2025

Monitoring physiological status based on bio- vibrational and radio frequency data analysis

Inventors: Kent Volosin (Mars, PA); Gary A. Freeman (Waltham, MA)
Assignee: ZOLL Medical Corporation
A61B5/7275A61B5/05A61B5/0535A61B5/1102A61B5/366A61B5/7264H04Q9/00A61B2562/0219
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 12,213,812
App. No.
18/494,359
Granted
Feb 4, 2025
Kind
B2
Abstract

A patient monitoring device includes an ECG sensor coupled to a patient, a sensor coupled to the patient and configured to detect bio-vibrational signals, and a radiofrequency monitoring device configured to produce information responsive to electromagnetic energy reflected from the patient's thoracic cavity. A processor processes the ECG signals, the bio-vibrational signals, and the radio frequency information to generate a plurality of physiological parameters of the patient. The processor also performs at least one of a predictive analysis and a trend analysis of the plurality of physiological parameters to determine a current clinical condition of the patient. The trend analysis includes determining a substantial relationship between changes in the plurality of physiological parameters. The processor can also compare the current clinical condition of the patient to predetermined clinically actionable criteria to determine one or more clinically actionable events and provide an output relating to one or more clinically actionable events.

Claims (41)

1. An externally worn cardiac monitoring and treatment system comprising:

an ECG sensor coupled to a patient and configured to detect one or more ECG signals of the patient;

a therapy electrode configured to deliver a therapeutic shock to the patient;

a vibrational sensor coupled to the patient and configured to detect one or more cardio-vibrational signals of the patient;

a radiofrequency transceiver circuit comprising one or more radiofrequency antennas, the radiofrequency transceiver circuit configured to

cause the one or more radiofrequency antennas to direct radiofrequency energy into at least a portion of the patient, and

produce radiofrequency information responsive to reflected radiofrequency energy that is received through the one or more radiofrequency antennas and that is reflected from within the patient; and

one or more processors configured to

process the one or more ECG signals and the one or more cardio-vibrational signals to generate a combinational parameter,

process the radiofrequency information to generate a thoracic fluid content measurement of the patient,

perform a correlation analysis on the combinational parameter and the thoracic fluid content measurement to determine a current clinical condition of the patient, wherein the current clinical condition of the patient indicates a possible occurrence of a cardiac arrhythmia,

compare the current clinical condition of the patient to predetermined clinically actionable criteria to identify one or more clinically actionable events, and

cause an output device to provide an output relating to the one or more clinically actionable events; and

therapy delivery circuitry that is operably connected to the therapy electrode and that is configured to treat the cardiac arrhythmia by providing a therapeutic shock to the patient using the therapy electrode.

2. The system of claim 1 , wherein the correlation analysis is performed on the combinational parameter and the thoracic fluid content measurement over a prior period of time including one or more of: at least 24 hours, at least 48 hours, at least one week, at least two weeks, at least one month, at least 6 weeks, at least two months, at least 4 months, at least 6 months, at least 1 year, or at least 2 years.

3. The system of claim 1 , wherein the correlation analysis is performed on the combinational parameter and the thoracic fluid content measurement over a prior period of time corresponding to at least an available clinical history of the patient.

4. The system of claim 1 , wherein the one or more clinically actionable events comprise at least one of:

an automated event that is triggered without user input; or

a manual event that is triggered based upon a user response to the output and comprises one or more instructions to perform one or more actions.

5. The system of claim 4 , wherein the automated event comprises configuring the cardiac monitoring and treatment system to increase a sensitivity of an ECG signal detection process for a period of time.

6. The system of claim 1 , wherein the output relating to the one or more clinically actionable events is based on a transgression of one or more thresholds defined with respect to results of the correlation analysis.

7. The system of claim 1 , wherein the current clinical condition of the patient comprises a predictive score that indicates a likelihood of the cardiac arrhythmia.

8. The system of claim 1 , wherein performing the correlation analysis further comprises determining that at least one of:

the combinational parameter has exceeded a combinational parameter threshold; or

the thoracic fluid content measurement has exceeded a thoracic fluid content measurement threshold.

9. The system of claim 1 , wherein performing the correlation analysis further comprises calculating a correlation score that indicates a change in the current clinical condition of the patient.

10. The system of claim 1 , wherein the vibrational sensor is further configured to sense one or more lung vibrations for the patient, the one or more lung vibrations comprising at least one of bronchial vibrations, stridor, crackle, wheeze, rhonchus, pleural friction, squawk, glottal, pharyngeal, or other vibrations.

11. The system of claim 1 , wherein the one or more ECG signals comprise at least one of heart rate; heart rate variability; PVC burden or counts; atrial fibrillation burden; pauses; heart rate turbulence; QRS height; QRS width; changes in size or shape of ECG morphology; cosine R-T; artificial pacing; QT interval; QT variability; T wave width; T wave alternans; T-wave variability; or ST segment changes.

12. The system of claim 1 , wherein the one or more processors are further configured to perform a predictive analysis of a determined value of, or a trend in, the thoracic fluid content measurement.

13. The system of claim 1 , wherein the one or more processors are further configured to display, via the output device, a graphical timeline representing at least a portion of a monitoring period during which the cardiac monitoring and treatment system is worn by the patient.

14. The system of claim 13 , wherein the graphical timeline visually depicts a correlation between the combinational parameter and the thoracic fluid content measurement.

15. The system of claim 13 , wherein the monitoring period comprises one or more of at least 24 hours, at least 48 hours, at least one week, or at least two weeks.

16. The system of claim 1 , further comprising a garment, wherein the ECG sensor, the therapy electrode, and the vibrational sensor are coupled to the garment.

17. The system of claim 1 , wherein the one or more processors are further configured to perform a trend analysis on the combinational parameter to generate an overall classification score for the patient.

18. The system of claim 17 , wherein the one or more processors are further configured to update a monitoring schedule for the patient based on results of the trend analysis.

19. The system of claim 1 , wherein the combinational parameter comprises electromechanical activation time.

20. The system of claim 1 , wherein the combinational parameter comprises % LVST.

21. The system of claim 1 , wherein the one or more cardio-vibrational signals include at least one of an S1 vibration, an S2 vibration, an S3 vibration, an S4 vibration, or a heart murmur vibration.

22. The system of claim 1 , wherein the one or more processors are further configured to determine a left ventricular systolic time metric based on the one or more cardio-vibrational signals.

23. The system of claim 1 , wherein the one or more cardio-vibrational signals comprise at least one of an S1 vibration, an S2 vibration, an S3 vibration, or an S4 vibration.

24. The system of claim 1 , wherein the one or more cardio-vibrational signals comprise a heart murmur vibration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 30, 2023
From: VOLOSIN, KENT; FREEMAN, GARY A.
To: ZOLL MEDICAL CORPORATION
Reel/Frame 065721/0307 →
Continuity (4)
Continuation 17156919 · Jan 25, 2021
Continuation 16355171 · Mar 15, 2019
Provisional Application 62644216 · Mar 16, 2018
Related Publication 20240074710A1 · Mar 7, 2024
References Cited (165)
US 4576170A · Bradley et al. · 1986 [cited by applicant]
US 4580572A · Granek et al. · 1986 [cited by applicant]
US 4583547A · Granek et al. · 1986 [cited by applicant]
US 4729377A · Granek et al. · 1988 [cited by applicant]
US 4928690A · Heilman et al. · 1990 [cited by applicant]
US 4991217A · Garrett et al. · 1991 [cited by applicant]
US 5078134A · Heilman et al. · 1992 [cited by applicant]
US 5741306A · Glegyak et al. · 1998 [cited by applicant]
US 5929601A · Kaib et al. · 1999 [cited by applicant]
US 5944669A · Kaib · 1999 [cited by applicant]
US 6016445A · Baura · 2000 [cited by applicant]
US 6065154A · Hulings et al. · 2000 [cited by applicant]
US 6097982A · Glegyak et al. · 2000 [cited by applicant]
US 6253099B1 · Oskin et al. · 2001 [cited by applicant]
US 6280461B1 · Glegyak et al. · 2001 [cited by applicant]
US 6336900B1 · Alleckson et al. · 2002 [cited by applicant]
US 6374138B1 · Owen et al. · 2002 [cited by applicant]
US 6406426B1 · Reuss et al. · 2002 [cited by applicant]
US 6546285B1 · Owen et al. · 2003 [cited by applicant]
US 6681003B2 · Linder et al. · 2004 [cited by applicant]
US 6889078B2 · Struble et al. · 2005 [cited by applicant]
US 6889079B2 · Bocek et al. · 2005 [cited by applicant]
US 6908437B2 · Bardy · 2005 [cited by applicant]
US 7122012B2 · Bouton et al. · 2006 [cited by applicant]
US 7149579B1 · Koh et al. · 2006 [cited by applicant]
US 7340296B2 · Stahmann et al. · 2008 [cited by applicant]
US 7453354B2 · Reiter et al. · 2008 [cited by applicant]
US 7476206B2 · Palazzolo et al. · 2009 [cited by applicant]
US 7488293B2 · Marcovecchio et al. · 2009 [cited by applicant]
US 7712373B2 · Nagle et al. · 2010 [cited by applicant]
US 7725150B2 · Tupin, Jr. et al. · 2010 [cited by applicant]
US 7831303B2 · Rueter et al. · 2010 [cited by applicant]
US 7974689B2 · Volpe et al. · 2011 [cited by applicant]
US 7991460B2 · Fischell et al. · 2011 [cited by applicant]
US 8121683B2 · Bucher et al. · 2012 [cited by applicant]
US 8140154B2 · Donnelly et al. · 2012 [cited by applicant]
US 8271082B2 · Donnelly et al. · 2012 [cited by applicant]
US 8369944B2 · Macho et al. · 2013 [cited by applicant]
US 8406842B2 · Kaib et al. · 2013 [cited by applicant]
US 8412323B2 · Bauer · 2013 [cited by applicant]
US 8644925B2 · Volpe et al. · 2014 [cited by applicant]
US 8649861B2 · Donnelly et al. · 2014 [cited by applicant]
US 8676313B2 · Volpe et al. · 2014 [cited by applicant]
US 8706215B2 · Kaib et al. · 2014 [cited by applicant]
US 8774917B2 · Macho et al. · 2014 [cited by applicant]
US 8880196B2 · Kaib · 2014 [cited by applicant]
US 8897860B2 · Volpe et al. · 2014 [cited by applicant]
US 8904214B2 · Volpe et al. · 2014 [cited by applicant]
US 8989837B2 · Weinstein et al. · 2015 [cited by applicant]
US 9002427B2 · Tupin, Jr. et al. · 2015 [cited by applicant]
US 9283399B2 · Donnelly et al. · 2016 [cited by applicant]
US 9675251B2 · Saroka et al. · 2017 [cited by applicant]
US 10595775B2 · Soykan · 2020 [cited by applicant]
US 10932726B2 · Volosin · 2021 [cited by examiner]
US 11826174B2 · Volosin · 2023 [cited by examiner]
US 20010031991A1 · Russial · 2001 [cited by applicant]
US 20030004547A1 · Owen et al. · 2003 [cited by applicant]
US 20030032988A1 · Fincke · 2003 [cited by applicant]
US 20030095648A1 · Kaib et al. · 2003 [cited by applicant]
US 20050131465A1 · Freeman et al. · 2005 [cited by applicant]
US 20060030781A1 · Shennib · 2006 [cited by applicant]
US 20060036292A1 · Smith et al. · 2006 [cited by applicant]
US 20060111641A1 · Manera et al. · 2006 [cited by applicant]
US 20060211934A1 · Hassonjee et al. · 2006 [cited by applicant]
US 20060264776A1 · Stahmann et al. · 2006 [cited by applicant]
US 20060293714A1 · Salo et al. · 2006 [cited by applicant]
US 20070161913A1 · Farrell et al. · 2007 [cited by applicant]
US 20070265671A1 · Roberts et al. · 2007 [cited by applicant]
US 20080033495A1 · Kumar · 2008 [cited by applicant]
US 20080306560A1 · Macho et al. · 2008 [cited by applicant]
US 20080306562A1 · Donnelly et al. · 2008 [cited by applicant]
US 20080312709A1 · Volpe et al. · 2008 [cited by applicant]
US 20090076363A1 · Bly et al. · 2009 [cited by applicant]
US 20090076405A1 · Amurthur et al. · 2009 [cited by applicant]
US 20090076410A1 · Libbus et al. · 2009 [cited by applicant]
US 20090076559A1 · Libbus et al. · 2009 [cited by applicant]
US 20090093687A1 · Telfort et al. · 2009 [cited by applicant]
US 20090138059A1 · Ouwerkerk · 2009 [cited by applicant]
US 20090234410A1 · Libbus et al. · 2009 [cited by applicant]
US 20090240133A1 · Friedman et al. · 2009 [cited by applicant]
US 20090264792A1 · Mazar · 2009 [cited by applicant]
US 20090292194A1 · Libbus et al. · 2009 [cited by applicant]
US 20090312650A1 · Maile et al. · 2009 [cited by applicant]
US 20100052892A1 · Allen et al. · 2010 [cited by applicant]
US 20100069735A1 · Berkner · 2010 [cited by applicant]
US 20100076533A1 · Dar et al. · 2010 [cited by applicant]
US 20100234716A1 · Engel · 2010 [cited by applicant]
US 20100256462A1 · Rappaport et al. · 2010 [cited by applicant]
US 20100298899A1 · Donnelly et al. · 2010 [cited by applicant]
US 20100312297A1 · Volpe et al. · 2010 [cited by applicant]
US 20110022105A9 · Owen et al. · 2011 [cited by applicant]
US 20110060215A1 · Tupin, Jr. et al. · 2011 [cited by applicant]
US 20110105932A1 · Bauer et al. · 2011 [cited by applicant]
US 20110130800A1 · Weinstein et al. · 2011 [cited by applicant]
US 20110170692A1 · Konrad et al. · 2011 [cited by applicant]
US 20110288604A1 · Kaib et al. · 2011 [cited by applicant]
US 20110288605A1 · Kaib et al. · 2011 [cited by applicant]
US 20120011382A1 · Volpe et al. · 2012 [cited by applicant]
US 20120112903A1 · Kaib et al. · 2012 [cited by applicant]
US 20120146797A1 · Oskin et al. · 2012 [cited by applicant]
US 20120150008A1 · Kaib et al. · 2012 [cited by applicant]
US 20120158075A1 · Kaib et al. · 2012 [cited by applicant]
US 20120283794A1 · Kaib et al. · 2012 [cited by applicant]
US 20120289809A1 · Kaib et al. · 2012 [cited by applicant]
US 20120293323A1 · Kaib et al. · 2012 [cited by applicant]
US 20120302860A1 · Volpe et al. · 2012 [cited by applicant]
US 20130013014A1 · Donnelly et al. · 2013 [cited by applicant]
US 20130060103A1 · Bergida et al. · 2013 [cited by applicant]
US 20130060149A1 · Song et al. · 2013 [cited by applicant]
US 20130085538A1 · Volpe et al. · 2013 [cited by applicant]
US 20130144355A1 · Macho et al. · 2013 [cited by applicant]
US 20130218252A1 · Kaib et al. · 2013 [cited by applicant]
US 20130231711A1 · Kaib · 2013 [cited by applicant]
US 20130282149A1 · Kuntagod · 2013 [cited by examiner]
US 20130324868A1 · Kaib et al. · 2013 [cited by applicant]
US 20130325078A1 · Whiting et al. · 2013 [cited by applicant]
US 20130325096A1 · Dupelle et al. · 2013 [cited by applicant]
US 20140155762A1 · Maskara et al. · 2014 [cited by applicant]
US 20140163334A1 · Volpe et al. · 2014 [cited by applicant]
US 20140206974A1 · Volpe et al. · 2014 [cited by applicant]
US 20140277243A1 · Maskara et al. · 2014 [cited by applicant]
US 20140288610A1 · Freeman · 2014 [cited by applicant]
US 20140303680A1 · Donnelly et al. · 2014 [cited by applicant]
US 20140324112A1 · Macho et al. · 2014 [cited by applicant]
US 20150005588A1 · Herken et al. · 2015 [cited by applicant]
US 20150035654A1 · Kaib et al. · 2015 [cited by applicant]
US 20150039042A1 · Amsler et al. · 2015 [cited by applicant]
US 20150039053A1 · Kaib et al. · 2015 [cited by applicant]
US 20150080699A1 · Kaib et al. · 2015 [cited by applicant]
US 20150224330A1 · Kaib et al. · 2015 [cited by applicant]
US 20160135706A1 · Sullivan et al. · 2016 [cited by applicant]
US 20160163187A1 · Treacy · 2016 [cited by examiner]
US 20160235331A1 · Iskander et al. · 2016 [cited by applicant]
US 20160270738A1 · Volpe · 2016 [cited by examiner]
US 20160345845A1 · Ravid et al. · 2016 [cited by applicant]
US 20170065823A1 · Kaib et al. · 2017 [cited by applicant]
US 20170143977A1 · Kaib et al. · 2017 [cited by applicant]
CN 101553163A · 2009 [cited by applicant]
CN 105942997A · 2016 [cited by applicant]
CN 105992552A · 2016 [cited by applicant]
CN 106132286A · 2016 [cited by applicant]
JP 2002514107A · 2002 [cited by applicant]
JP 2008302225A2 · 2008 [cited by applicant]
JP 2008302228A · 2008 [cited by applicant]
JP 2009510631A · 2009 [cited by applicant]
JP 2010537767A2 · 2010 [cited by applicant]
JP 2018503885A · 2018 [cited by applicant]
WO 1983004171A1 · 1983 [cited by applicant]
WO 1998039061A2 · 1998 [cited by applicant]
WO 2004078259A1 · 2004 [cited by applicant]
WO 2008036396A2 · 2008 [cited by applicant]
WO 2009031149A2 · 2009 [cited by applicant]
WO 2009122277A2 · 2009 [cited by applicant]
WO 2012006524A1 · 2012 [cited by applicant]
WO 2013130957A2 · 2013 [cited by applicant]
WO 2014097035A1 · 2014 [cited by applicant]
WO 2015134556A1 · 2015 [cited by applicant]
Zoll Medical Corporation, LifeVest Model WCD 3000 Operator's Manual, 2012, Pittsburgh, PA. [cited by applicant]
Bohadana et al., “Fundamentals of Lung Auscultation”, N Engl J Med, 370:744-751 (2014). [cited by applicant]
Köhler et al., “The Principles of Software QRS Detection”, IEEE Engineering in Medicine and Biology Magazine, 21 (1):42-57 (Feb. 2002). [cited by applicant]
American Journal of Respiratory and Critical Care Medicine, vol. 166, pp. 111-117 (2002), American Thoracic Society, ATS Statement: Guidelines for the Six-Minute Walk Test, available at http://ajrccm.atsjournals.org/cgi… [cited by applicant]
Association for the Advancement of Medical Instrumentation, ANSI/AAMI DF80:2003 Medical Electrical Equipment—Part 2-4: Particular Requirements for the Safety of Cardiac Defibrillators (including Automated External Defib… [cited by applicant]
http://web.archive.org/web/20030427001846/http:/www.lifecor.comiimagelib/imageproduct.asp. Published by LifeCor, Inc., 2002, on a webpage owned by LifeCor, Inc. [cited by applicant]
International Preliminary Report on Patentability for Application No. PCT/US2019/022553 dated Sep. 22, 2020, 11 pages. [cited by applicant]
PCT Search Report and Written Opinion for PCT Application No. PCT/US19/22553, mailed on Jun. 11, 2019, 13 pages. [cited by applicant]