IP Library › Granted Patent US 12,482,562
Granted Patent B2
US 12,482,562 · App. 18/736,852 · Granted Nov 25, 2025

Systems and methods for and displaying patient data

Inventors: Stephen Trey Moore (San Antonio, TX); Thomas Scott Wade (Wimberley, TX); Lloyd Kory Brown (Georgetown, TX)
Assignee: AirStrip IP Holdings, LLC
G16H40/67G06Q10/10G16H10/60G16H15/00G16H40/63
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Quick Facts
Patent No.
US 12,482,562
App. No.
18/736,852
Filed
Jun 7, 2024
Granted
Nov 25, 2025
Kind
B2
Art Unit
3687
USPC
705/3
Abstract

Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for receiving user input, the user input indicating a user command to display a waveform strip screen, in response to the user input, processing patient-specific data to provide waveform data, and displaying the waveform strip screen on the mobile device, the waveform strip screen displaying one or more waveform strips, each waveform strip of the one or more waveform strips being based on the waveform data and graphically depicting a physical waveform strip.

Claims (46)

1 . A computer-implemented method executed using one or more processors, the method comprising:

receiving first user input to provide a request for patient data and to determine a type of a computing device associated with the request, data identifiers of the patient data, and an identifier associated with a user of the computing device;

transmitting, to a data management system, the request, the data identifiers, and the identifier associated with the user of the computing device;

receiving, from the data management system, the patient data retrieved by the data management system from a facility system based on a user-facility index that maps the identifier associated with the user of the computing device to the facility system that the user is associated with as a healthcare provider, the patient data comprising one or more physiological data that varies over time;

processing the patient data to generate one or more graphical representations of the patient data based on the type of the computing device associated with the request, at least one graphical representation of the one or more graphical representations comprising a waveform strip; and

displaying the at least one graphical representation as a stacked waveform strip depicting a single physiological waveform, the stacked waveform strip comprising:

a first strip segment, the first strip segment comprising a first portion of the single physiological waveform that is updated in real-time and is associated with a first time period;

a second strip segment, the second strip segment comprising a second portion of the single physiological waveform that is updated in real-time and is associated with a second time period earlier than the first time period and being displayed beneath the first strip segment, such that a right edge of the second strip segment corresponds to a left edge of the first strip segment; and

a third strip segment, the third strip segment comprising a third portion of the single physiological waveform that is updated in real-time and is associated with a third time period earlier than the second time period and being displayed beneath the second strip segment, such that a right edge of the third strip segment corresponds to a left edge of the second strip segment.

2 . The method of claim 1 , further comprising receiving the patient data, the patient data reflective of one or more physiological characteristics of a patient.

3 . The method of claim 1 , further comprising receiving second user input indicating a zoom command, and in response to the second user input, providing a graphical representation comprising a zoomed stacked waveform strip.

4 . The method of claim 3 , wherein the zoomed waveform strip comprises a greater number of strip segments than the stacked waveform strip.

5 . The method of claim 3 , wherein the zoomed waveform strip comprises a lower number of strip segments than the stacked waveform strip.

6 . The method of claim 3 , wherein the zoom command comprises a command to zoom out.

7 . The method of claim 3 , wherein the zoom command comprises a command to zoom in.

8 . The method of claim 1 , wherein stacked waveform strip comprises a real-time waveform strip.

9 . The method of claim 8 , wherein the real-time waveform strip is updated in response to patient data provided from a remote monitoring device.

10 . A non-transitory computer-readable storage device coupled to one or more processors and having instructions stored thereon which, when executed by the one or more processors, cause the one or more processors to perform operations comprising:

receiving first user input to provide a request for patient data and to determine a type of a computing device associated with the request, data identifiers of the patient data, and an identifier associated with a user of the computing device;

transmitting, to a data management system, the request, the data identifiers, and the identifier associated with the user of the computing device;

receiving, from the data management system, the patient data retrieved by the data management system from a facility system based on a user-facility index that maps the identifier associated with the user of the computing device to the facility system that the user is associated with as a healthcare provider, the patient data comprising one or more physiological data that varies over time;

processing the patient data to generate one or more graphical representations of the patient data based on the type of the computing device associated with the request, at least one graphical representation of the one or more graphical representations comprising a waveform strip; and

displaying the at least one graphical representation as a stacked waveform strip depicting a single physiological waveform, the stacked waveform strip comprising:

a first strip segment, the first strip segment comprising a first portion of the single physiological waveform that is updated in real-time and is associated with a first time period,

a second strip segment, the second strip segment comprising a second portion of the single physiological waveform that is updated in real-time and is associated with a second time period earlier than the first time period and being displayed beneath the first strip segment, such that a right edge of the second strip segment corresponds to a left edge of the first strip segment, and

a third strip segment, the third strip segment comprising a third portion of the single physiological waveform that is updated in real-time and is associated with a third time period earlier than the second time period and being displayed beneath the second strip segment, such that a right edge of the third strip segment corresponds to a left edge of the second strip segment.

11 . The non-transitory computer-readable storage device of claim 10 , wherein operations further comprise receiving the patient data, the patient data reflective of one or more physiological characteristics of a patient.

12 . The non-transitory computer-readable storage device of claim 10 , wherein operations further comprise receiving second user input indicating a zoom command, and in response to the second user input, providing a graphical representation comprising a zoomed stacked waveform strip.

13 . The non-transitory computer-readable storage device of claim 12 , wherein the zoomed waveform strip comprises a greater number of strip segments than the stacked waveform strip.

14 . The non-transitory computer-readable storage device of claim 12 , wherein the zoomed waveform strip comprises a lower number of strip segments than the stacked waveform strip.

15 . The non-transitory computer-readable storage device of claim 12 , wherein the zoom command comprises a command to zoom out.

16 . The non-transitory computer-readable storage device of claim 12 , wherein the zoom command comprises a command to zoom in.

17 . The non-transitory computer-readable storage device of claim 10 , wherein stacked waveform strip comprises a real-time waveform strip.

18 . The non-transitory computer-readable storage device of claim 17 , wherein the real-time waveform strip is updated in response to patient data provided from a remote monitoring device.

19 . A system, comprising:

one or more processors; and

a computer-readable storage medium in communication with the one or more processors and having instructions stored thereon which, when executed by the one or more processors, cause the one or more processors to perform operations comprising:

receiving first user input to provide a request for patient data and to determine a type of a computing device associated with the request, data identifiers of the patient data, and an identifier associated with a user of the computing device;

transmitting, to a data management system, the request, the data identifiers, and the identifier associated with the user of the computing device;

receiving, from the data management system, the patient data retrieved by the data management system from a facility system based on a user-facility index that maps the identifier associated with the user of the computing device to the facility system that the user is associated with as a healthcare provider, the patient data comprising one or more physiological data that varies over time;

processing the patient data to generate one or more graphical representations of the patient data based on the type of the computing device associated with the request, at least one graphical representation of the one or more graphical representations comprising a waveform strip; and

displaying the at least one graphical representation as a stacked waveform strip depicting a single physiological waveform, the stacked waveform strip comprising:

a first strip segment, the first strip segment comprising a first portion of the single physiological waveform that is updated in real-time and is associated with a first time period,

a second strip segment, the second strip segment comprising a second portion of the single physiological waveform that is updated in real-time and is associated with a second time period earlier than the first time period and being displayed beneath the first strip segment, such that a right edge of the second strip segment corresponds to a left edge of the first strip segment, and

a third strip segment, the third strip segment comprising a third portion of the single physiological waveform that is updated in real-time and is associated with a third time period earlier than the second time period and being displayed beneath the second strip segment, such that a right edge of the third strip segment corresponds to a left edge of the second strip segment.

20 . The system of claim 19 , wherein operations further comprise receiving the patient data, the patient data reflective of one or more physiological characteristics of a patient.

Assignments (2)
SECURITY INTEREST Recorded Oct 6, 2025
From: AIRSTRIP IP HOLDINGS, LLC; AIRSTRIP OPERATIONS, LLC; DECISIO HEALTH, LLC
To: ORBIMED ROYALTY & CREDIT OPPORTUNITIES IV, LP, AS ADMINISTRATIVE AGENT
Reel/Frame 072480/0096 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2024
From: MOORE, STEPHEN TREY; WADE, THOMAS SCOTT; BROWN, LLOYD KORY
To: AIRSTRIP IP HOLDINGS, LLC
Reel/Frame 067658/0045 →
Continuity (4)
Continuation 17583996 · Jan 25, 2022
Continuation 13798661 · Mar 13, 2013
Provisional Application 61624954 · Apr 16, 2012
Related Publication 20240321446A1 · Sep 26, 2024
References Cited (144)
US 3893453A · Goldberg et al. · 1975 [cited by applicant]
US 4340065A · Gessman · 1982 [cited by applicant]
US 4873987A · Djordjevic et al. · 1989 [cited by applicant]
US 4896677A · Kaneko et al. · 1990 [cited by applicant]
US 4989610A · Patton et al. · 1991 [cited by applicant]
US 5447164A · Shaya et al. · 1995 [cited by applicant]
US 5788646A · Fuchs et al. · 1998 [cited by applicant]
US 6007491A · Ling et al. · 1999 [cited by applicant]
US 6473638B2 · Ferek-Petric · 2002 [cited by examiner]
US 6621508B1 · Shiraishi et al. · 2003 [cited by applicant]
US 6967652B1 · Nubling · 2005 [cited by examiner]
US 7171630B2 · O'Leary · 2007 [cited by examiner]
US 7227549B2 · Beasley et al. · 2007 [cited by applicant]
US 8152710B2 · Dlugos, Jr. · 2012 [cited by examiner]
US 8209002B2 · Vajdic et al. · 2012 [cited by applicant]
US 9092727B1 · Reicher · 2015 [cited by applicant]
US 9524569B2 · Moore et al. · 2016 [cited by applicant]
US 10231653B2 · Bohm et al. · 2019 [cited by applicant]
US 10402782B2 · Moore et al. · 2019 [cited by applicant]
US 11238983B2 · Moore · 2022 [cited by examiner]
US 11403795B2 · Moore et al. · 2022 [cited by applicant]
US 20010017707A1 · Lee · 2001 [cited by applicant]
US 20010044586A1 · Ferek-Petric · 2001 [cited by applicant]
US 20020154111A1 · Webb · 2002 [cited by applicant]
US 20020194305A1 · Sadeghi et al. · 2002 [cited by applicant]
US 20020198473A1 · Kumar et al. · 2002 [cited by applicant]
US 20030105389A1 · Noonan et al. · 2003 [cited by applicant]
US 20040054294A1 · Ramseth · 2004 [cited by applicant]
US 20040102710A1 · Kim · 2004 [cited by applicant]
US 20040204635A1 · Scharf · 2004 [cited by examiner]
US 20060149597A1 · Powell · 2006 [cited by examiner]
US 20060264769A1 · Satin et al. · 2006 [cited by applicant]
US 20060265249A1 · Follis et al. · 2006 [cited by applicant]
US 20070156966A1 · Sundarrajan et al. · 2007 [cited by applicant]
US 20070162424A1 · Jeh et al. · 2007 [cited by applicant]
US 20070191721A1 · Parker et al. · 2007 [cited by applicant]
US 20070191740A1 · Shertukde et al. · 2007 [cited by applicant]
US 20080114808A1 · Morita et al. · 2008 [cited by applicant]
US 20090012415A1 · Thiagarajan et al. · 2009 [cited by applicant]
US 20090076402A1 · Hoium et al. · 2009 [cited by applicant]
US 20090222286A1 · Elsholz · 2009 [cited by applicant]
US 20090241048A1 · Augustine et al. · 2009 [cited by applicant]
US 20090292180A1 · Mirow · 2009 [cited by applicant]
US 20100174553A1 · Kaufman et al. · 2010 [cited by applicant]
US 20100198619A1 · Whelchel et al. · 2010 [cited by applicant]
US 20100235782A1 · Powell · 2010 [cited by examiner]
US 20110092838A1 · Helfenbein et al. · 2011 [cited by applicant]
US 20110251960A1 · Holla et al. · 2011 [cited by applicant]
US 20110301478A1 · Ben-Sira · 2011 [cited by applicant]
US 20120075103A1 · Powell et al. · 2012 [cited by applicant]
US 20120101398A1 · Ramanathan et al. · 2012 [cited by applicant]
US 20120123223A1 · Freeman et al. · 2012 [cited by applicant]
US 20120130741A1 · Sparandara et al. · 2012 [cited by applicant]
US 20120131495A1 · Goossens et al. · 2012 [cited by applicant]
US 20120206475A1 · Bryant et al. · 2012 [cited by applicant]
US 20130024206A1 · Hughes et al. · 2013 [cited by applicant]
US 20130024208A1 · Vining · 2013 [cited by applicant]
US 20130271469A1 · Moore et al. · 2013 [cited by applicant]
US 20130271470A1 · Moore et al. · 2013 [cited by applicant]
US 20130275151A1 · Moore et al. · 2013 [cited by applicant]
US 20130275152A1 · Moore et al. · 2013 [cited by applicant]
US 20200357493A1 · Kelly · 2020 [cited by examiner]
US 20220223276A1 · Moore et al. · 2022 [cited by applicant]
US 20220262051A1 · Moore et al. · 2022 [cited by applicant]
CA 2788836 · 2011 [cited by applicant]
EP 1205143 · 2002 [cited by applicant]
EP 1205143A2 · 2002 [cited by examiner]
JP H02111341 · 1990 [cited by applicant]
JP 2000316819 · 2000 [cited by applicant]
JP 2003047599 · 2003 [cited by applicant]
JP 2003135415 · 2003 [cited by applicant]
JP 2003225220 · 2003 [cited by applicant]
JP 2003284698 · 2003 [cited by applicant]
JP 2004129788 · 2004 [cited by applicant]
JP 2004174230 · 2004 [cited by applicant]
JP 2004261583 · 2004 [cited by applicant]
JP 2007190227 · 2007 [cited by applicant]
JP 2009518732 · 2009 [cited by applicant]
JP 2010214016 · 2010 [cited by applicant]
JP 2011233161 · 2011 [cited by applicant]
JP 201255354 · 2012 [cited by applicant]
JP 2012529351 · 2012 [cited by applicant]
JP 2013527503 · 2013 [cited by applicant]
WO WO03040908A1 · 2003 [cited by examiner]
WO WO2010054409 · 2010 [cited by applicant]
WO WO2010058139 · 2010 [cited by applicant]
WO WO2011122404 · 2011 [cited by applicant]
WO WO2013158625 · 2013 [cited by applicant]
WO WO2013158632 · 2013 [cited by applicant]
Agilent Technologies, Inc., “Generating Complex ECG Patterns with an Arbitrary Waveform Generator,” Measurement Tips, vol. 10, No. 3, Jul. 1, 2010, 4 pages. [cited by applicant]
Airstriptech. Airstrip Cardiology IPad Demo. May 3, 2011. [retrieved on Jun. 24, 2013]. Retrieved from the Internet:<URL:http:www.youtube.comwatch?v=6V15m9A4wd0>. entire document. [cited by applicant]
Authorized Officer Blaine R. Copenheaver, International Search Report and Written Opinion of the International Searching Authority for International Application No. PCTUS2013036758, mailed Jun. 28, 2013, 24 pages. [cited by applicant]
Authorized Officer Blaine R. Copenheaver, International Search Report and Written Opinion of the International Searching Authority for International Application No. PCTUS2013036769, mailed Aug. 28, 2013, 13 pages. [cited by applicant]
Authorized Officer Mineko Mohri, International Preliminary Report on Patentability for International Application No. PCTUS2013036758, mailed Oct. 30, 2014, 21 pages. [cited by applicant]
Authorized Officer Simin Baharlou, International Preliminary Report on Patentability for International Application No. PCTUS2013036769, mailed Oct. 30, 2014, 7 pages. [cited by applicant]
Decision to Dismiss the Amendment for Japanese Patent Application No. 2015-507107, dated Aug. 22, 2018, 6 pages (with English Translation). [cited by applicant]
Decision to Grant a Patent for Japanese Patent Application No. 2015-507108, dated Sep. 28, 2017, 3 pages [with English translation]. [cited by applicant]
Defendant's Answer and Counterclaim, [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Agilent Information Center (AIC) Software Release D.0 (K011093), Ma… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Alarm View™ System (K992848), Nov. 19, 1999, 6 pages. [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Alarm View™ Wireless Data Network System (K010912), Apr. 5, 2001, 4… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Alarm View™ Wireless Data Network System (K012005), Jul. 24, 2001, … [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Alarm View™ Wireless Data Network System (K013156), Oct. 19, 2001, … [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Cardio-Pager™ System (K973527), Mar. 31, 1998, 6 pages. [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Datex-Ohmeda S5 Web Viewer, Datex-Ohmeda S5 Pocket Viewer and Datex… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for FlexView™ Clinical Monitoring System (K003998), Mar. 7, 2001, 4 pag… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for FlexView™ Clinical Monitoring System (K011999), Jul. 24, 2001, 4 pa… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Hewlett-Packard M2605A Viridia Wave Viewer (K974567), Jan. 20, 1998… [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Mobile-Patient Viewer™ (K011436), Jul. 5, 2001, 5 pages. [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for RhythmStat XL System (K971650), Dec. 4, 1997, 9 pages. [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Stat View™ System (K990378), Sep. 20, 1999, 6 pages. [cited by applicant]
Department of Health & Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 510(k) Summary and approval letter for Web Viewer, Pocket Viewer and Cellular Viewer with L-WEB05 software… [cited by applicant]
Edward H. Schmuhl et al., “HP PalmVue: A New Healthcare Information Product,” Hewlett-Parkard Journal, Article 8, Jun. 1996, retrieved from http:www.hpl.hp.comhpjournal96junjun96a8.pdf, pp. 12-17. [cited by applicant]
Examination Report for Australian Patent Application No. 2013249417, dated Aug. 31, 2017, 4 pages. [cited by applicant]
Examination Report for Australian Patent Application No. 2013249417, dated Jan. 23, 2017, 4 pages. [cited by applicant]
Examination Report for Australian Patent Application No. 2013249502, dated Aug. 30, 2017, 4 pages. [cited by applicant]
Examination Report for Australian Patent Application No. 2013249502, dated Jul. 28, 2017, 4 pages. [cited by applicant]
Examination Report for Canadian Application No. 2,869,632, Oct. 17, 2019, 3 pages. [cited by applicant]
Examination Report for Canadian Application No. 2,869,632, Jan. 3, 2019, 4 pages. [cited by applicant]
Examination Report for Canadian Application No. 2,870,560, Jan. 3, 2019, 4 pages. [cited by applicant]
European Examination and Report for Application No. 13777472.5, dated Aug. 2, 2016, 6 pages. [cited by applicant]
European Examination and Supplementary Search Report for Application No. 13778942.6, dated Oct. 23, 2015, 6 pages. [cited by applicant]
Extended European Search Report for Application No. 13777472.5, dated Jan. 26, 2016, 9 pages. [cited by applicant]
Supplementary European Search Report for Application No. 13777472.5, dated Oct. 6, 2015, 4 pages. [cited by applicant]
Supplementary European Search Report for Application No. 13778942.6, dated Oct. 6, 2015, 2 pages. [cited by applicant]
GE Healthcare, “Web Viewer and Pocket Viewer,” 2007, retrieved from http:www3.gehealthcare.com˜mediaDownloadsusProductProduct-CategoriesPatient-MonitoringCareportsMobile-ViewersGEHealthcare-Web-Viewer-Pocket-Viewer-Prod… [cited by applicant]
Google patents search: displaying folded pages and animated, Jun. 30, 2016, 2 pages. [cited by applicant]
Google Search: Waveform Display and Strip Stack and Scale, Dec. 11, 2014, 2 pages. [cited by applicant]
Kissei America, Inc., “SleepSign Analysis Program,” available online since May 6, 2006, http://web.archive.org/web/20060506174919/http://www.sleepsign.com/dataAnalysis.html, 4 pages. [cited by applicant]
MobileInfo, “Data Critical's StatView™ Alarm Notification System,” Jun. 2000, retrieved from http:www.mobileinfo.comApplications_VerticalHealthcare_ApplicationsStat View.htm, 2 pages. [cited by applicant]
National Instruments, “Customizing Graphs and Charts,” LabVIEW 2011 Help, Jun. 2011, 10 pages. [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2018-239394, dated Mar. 12, 2020, 19 pages (with English translation). [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2015-507107, dated Apr. 10, 2017, 15 pages. [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2015-507107, dated Jan. 22, 2018, 8 pages. [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2015-507108, dated Nov. 7, 2016, 4 pages. [cited by applicant]
Notice of Reasons for Rejection for Japanese Patent Application No. 2021-104814, dated Sep. 28, 2022, 5 pages (with English Translation). [cited by applicant]
Omega's Electronics, “Agilent Technologies,” available online since Aug. 31, 2011, https://omegacs.wordpress.com/, 1 page. [cited by applicant]
Plaintiffs' Complaint for Patent Infringement, [cited by applicant]
PRweb, Cardio Calipers Software from Iconico Released; the On-Screen Electrocardiogram (EKG, ECG) Measurement Software for Windows, PRWeb. Mar. 21, 2006. (Retrieved on: Aug. 13, 2013). Retrieved from internet: <URL:http… [cited by applicant]
Roberts Blog, “Freeing the axes of the Microsoft toolkit charting control,” retrieved from <http://reyntjes.blogspot.com/2009/09/freeing-axes-of-microsoft-toolkit.html>, posted online Sep. 15, 2009, 8 pages. [cited by applicant]
Steven Elbinger et al: USPTO Office Action for U.S. Appl. No. 13/863,840, dated Jun. 3, 2015, 23 pages. [cited by applicant]
Sundvall, Erik, et al. “Graphical overview and navigation of electronic health records in a prototyping environment using Google Earth and openEHR archetypes.” Medinfo 2007: Proceedings of the 12th World Congress on Hea… [cited by applicant]
Telecompaper, “Data Critical Launches Rhythmstat XL Medical System,” Jan. 8, 1998, retrieved from http:www.telecompaper.comnewsdata-critical-launches-rhythmstat-xl-medical-system--26725, 2 pages. [cited by applicant]
U.S. Food and Drug Administration, Protecting and Promoting Your Health, “MAUDE Adverse Event Report: Data Critical Corp.Impactpaging System,” Nov. 19, 2000, retrieved on Apr. 8, 2013 from <www.accessdata.fda.govscripts… [cited by applicant]