US008273053B2
`
`(12) United States Patent
`Saltzstein
`
`(io) Patent No.: US 8,273,053 B2
`(45) Date of Patent:
`Sep. 25, 2012
`
`(54) PATIENT STATUS SENSOR
`
`(75)
`
`Inventor: William E. Saltzstein, Woodinville, WA
`(US)
`
`(73) Assignee: Pyng Medical Corp., Richmond (CA)
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 38 days.
`
`(21) Appl. No.: 12/773,730
`
`(22) Filed:
`
`May 4, 2010
`
`(65)
`
`Prior Publication Data
`US 2010/0286607 Al Nov. 11, 2010
`
`Related U.S. Application Data
`(60) Provisional application No. 61/175,746, filed on May
`5, 2009.
`
`(51) Int.Cl.
`(2006.01)
`A61M31/00
`(52) U.S. Cl............................................................. 604/93.01
`(58) Field of Classification Search ................... 600/301,
`600/393; 604/93.01
`See application file for complete search history.
`
`(56)
`
`References Cited
`u.s.:PATENT DOCUMENTS
`3,677,261 A
`7/1972 Day
`5/1994 Jacobs
`5,312,364 A
`8/1995 Kagan et al.
`5,443,072 A
`5,511,553 A *
`4/1996 Segalowitz ................... 600/508
`4/1997 Addis s
`5,623,938 A
`6/1997 Platt et al.
`5,634,468 A
`10/1998 Johnson et al.
`5,817,052 A
`5,948,006 A
`9/1999 Mann
`10/1999 Kramer et al.
`5,960,797 A
`6,081,194 A
`6/2000 Sanchez
`8/2001 Avicola et al.
`6,277,079 Bl
`
`6,572,636 Bl
`6,761,726 Bl
`7,347,840 B2
`7,670,328 B2
`7,699,850 B2
`2001/0014439 Al
`
`6/2003 Hagen et al.
`7/2004 Findlay et al.
`3/2008 Findlay et al.
`3/2010 Miller
`4/2010 Miller
`8/2001 Meller et al.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`WO WO 2009/036334
`3/2009
`OTHER PUBLICATIONS
`3M Red Dot Electrodes, Trusted Choices for Consistent Perfor­
`mance, Product Brochure, 2009.
`(Continued)
`
`Primary Examiner — Nicholas Lucchesi
`Assistant Examiner — Melissa A Snyder
`(74) Attorney, Agent, or Firm —Connolly Bove Lodge &
`Hutz LLP
`
`(57)
`ABSTRACT
`Embodiments of a patient status sensor can be applied to a
`patient or trauma victim to provide a quick visual and/or
`audible indication of the patient’s vital signs (e.g., respira­
`tion, heart rate, or other vital signs). Certain embodiments are
`configured as an adhesive patch that includes electrodes for
`measuring heart rate (and respiration in some implementa­
`tions), a processor configured to perform calculations for
`determining one or more vital signs using information from
`the electrodes, and audible or visual indicators to communi­
`cate information about vital signs or patient status to a medi­
`cal attendant. Certain embodiments include an access open­
`ing for providing intraosseous delivery of fluids to bone
`marrow (e.g., through sternal or long bone) and can be inte­
`grated or used with an intraosseous delivery system. Certain
`embodiments include wired or wireless components to com­
`municate vital signs or patient status to an external monitor­
`ing device.
`
`40 Claims, 13 Drawing Sheets
`
`104
`
`APPLE 1013
`
`1
`
`

`

`US 8,273,053 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`2/2005 Avicola et al.
`2005/0038348 Al
`2005/0277841 Al
`12/2005 Shennib
`2006/0030781 Al
`2/2006 Shennib
`2006/0030782 Al
`2/2006 Shennib
`2006/0264767 Al
`11/2006 Shennib
`2007/0049945 Al
`3/2007 Miller
`12/2007 Findlay et al.
`2007/0282181 Al
`4/2008 Guillory et al.
`2008/0091090 Al
`8/2008 Findlay et al.
`2008/0208136 Al
`2008/0287859 Al* 11/2008 Miller et al....................... 604/21
`12/2008 Omtveit et al.
`2008/0319278 Al
`3/2009 Sterling et al.
`2009/0062670 Al
`OTHER PUBLICATIONS
`Aerotel Medical Systems Ltd., Heartline—Heart 2005A & Heart
`2006—Single/Dual Lead Transtelephonic ECG Loop Event
`Recorder/Transmitter, downloaded Apr. 2010 from http://www.
`aerotel.com, in 2 pages.
`Aerotel Medical Systems Ltd., Heartline—The Best of Tele-Cardi­
`ology, downloaded Apr. 2010 from http://www.aerotel.com, in 2
`pages.
`Afonso, V., “ECGQRS Detection,” Chapter 12 in Biomedical Digital
`Signal Processing—C-Language Examples and Laboratory Experi­
`ments for the IBM PC edited by W. J. Tompkins, Prentice Hall, 1993,
`pp. 236-263.
`Alive Technologies Pty Ltd, Mobile Cardiac Monitoring—Bluetooth
`ECG and Activity Monitor Product Brochure, downloaded Apr. 2010
`fromwww.alivetec.com, in 1 page.
`Baker, L. E., “Applications of the Impedance Technique to the Res­
`piratory System,” IEEE Engineering in Medicine and Biology Maga­
`zine, Mar. 1989, pp. 50-52.
`Guidelines for Field Triage of Injured Patients: Recommendations of
`the National Expert Panel on Field Triage, Morbidity and Mortality
`Weekly Report, Centers for Disease Control and Prevention, Jan. 23,
`2009, vol. 48, No. RR-1.
`Christiaens et al., “3D Integration of Ultra-Thin Functional Devices
`Inside Standard Multilayer Flex Laminates,” Abstract from Micro­
`electronics and Packaging Conference, 2009 EMPC, Jun. 2009, in 1
`page.
`Eberle et al., “Health-Care Electronics—The Market, the Chal­
`lenges, the Progress, Design,” Abstract from Design, Automation &
`Test in Europe Conference & Exhibition, Apr. 2009, in 1 page.
`Folke et al., “Critical Review of Non-Invasive Respiratory Monitor­
`ing in Medical Care,” Medical & Biological Engineering & Comput­
`ing, vol. 41, pp. 377-383, 2003.
`Integrated Medical Devices, Inc., IMD Model 1200 Transtelephonic
`ECG Receiver, 2007.
`Ke et al., “A Patch-type Wireless Physiological Monitoring
`Microsystems,” Abstract from 9th International Conf, on e-Health
`Networking, Application and Services, Jun. 2007, in 1 page.
`
`Montgomery et al., “Lifeguard—A Personal Physiological Monitor
`for Extreme Environments,” available from http://lifeguard. Stanford.
`edu/presentations/embc_lifeguard_paper_FINAL.pdf in Feb.
`2010, in 4 pages.
`Nonin Medical, Inc., Onyx II Model 9560 Pulse Oximetry, Fingertip,
`Product Brochure, 2008.
`Pyng Medical Corp., “Chest is Best—FASTI Sternal Line is the
`Quickest Route to the Heart,” FASTI Intraosseous Infusion System
`Brochure, Aug. 2008.
`Pyng Medical Corp., FAST 1 Intraosseous Infusion System Trainer’s
`Manual, Aug. 2008, in 18 pages.
`Pyng Medical Corp., FASTI Intraosseous Infusion System, Selected
`Abstracts, downloaded from http://www.fastlsternal.com/about-io/
`technicalclinical/, Apr. 2010, in 7 pages.
`Pyng Medical Corp., FASTx Sternal Intraosseous Device Product
`Brochure, Apr. 2010.
`Pyng Medical Corp., K080865 510(k) Summary, dated Apr. 24,
`2008, in 5 pages.
`Raju, “Heart-Rate and EKG Monitor Using the MSP430FG439,”
`Application Report SLAA280A—Oct. 2005—Revised Sep. 2007,
`Texas Instruments Incorporated, pp. 1-12.
`Tompkins, W. J., “ECG Signal Characteristics,” in Biomedical Digi­
`tal Signal Processing—C-Language Examples and Laboratory
`Experiments for the IBM PC, Prentice Hall, 1993, p. 43.
`Bradycardia, from Wikipedia, downloaded Jun. 21, 2010, in 5 pages.
`Tachycardia, from Wikipedia, downloaded Jun. 21, 2010, in 6 pages.
`Triage, from Wikipedia, downloaded Jun. 21, 2010, in 14 pages.
`Vidacare, EZ-IO—Intraosseous Infusion System, EZ-IO Product
`System, downloaded Apr. 2010 from http://www.vidacare.com, in 4
`pages.
`Vidacare, EZ-IO—Intraosseous Infusion Systems Brochure, Product
`System for Military Use, downloaded Apr. 2010 from http://www.
`vidacare.com, in 4 pages.
`Vidacare, EZ-IO Product Systems for Military Use Specifications
`Sheet, downloaded Apr. 2010 from http://www.vidacare.com, in 2
`pages.
`Welch Allyn, Directions for Use, Micropaq Monitor, Model 402 and
`Model 404, 2007, in 76 pages.
`Welch Allyn, Propaq LT Vital Signs Monitor Quick Reference, 2005,
`in 1 page.
`Yang et al., “Intelligent Electrode Design for Long-Term ECG Moni­
`toring at Home: Prototype Design Using FPAA and FPGA,” Abstract
`from 3rd International Conference on Pervasive Computing Tech­
`nologies for Healthcare, Apr. 2009, in 1 page.
`Yoo et al., “A Wearable ECG Acquisition System with Compact
`Planar-Fashionable Circuit Board-Based Shirt,” IEEE Transactions
`on Information Technology in Biomedicine, vol. 13, No. 6, Nov.
`2009, pp. 897-902.
`International Search Report and Written Opinion ofthe International
`Searching Authority dated May 30, 2011 for corresponding Interna­
`tional Application No. PCT/US2010/054336 dated Oct. 27, 2010;
`total pages 10.
`* cited by examiner
`
`2
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`

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`Sheet 1 of 13
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`U.S. Patent
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`Sep. 25, 2012
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`Sheet 3 of 13
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`US 8,273,053 B2
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`U.S. Patent
`U.S. Patent
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`Sep. 25, 2012 Sheet 4 of 13
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`US 8,273,053 B2
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`

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`U.S. Patent
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`Sep. 25, 2012 Sheet 5 of 13
`Sep. 25, 2012
`Sheet 5 of 13
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`Sep. 25, 2012
`Sep. 25, 2012
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`Sheet 6 of 13
`Sheet 6 of 13
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`US 8,273,053 B2
`US 8,273,053 B2
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`600A
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`

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`Sep. 25, 2012
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`Sheet 7 of 13
`Sheet 7 of 13
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`Sep. 25, 2012
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`Sheet 8 of 13
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`US 8,273,053 B2
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`

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`U.S. Patent
`U.S. Patent
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`Sep. 25, 2012
`Sep. 25, 2012
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`Sheet 9 of 13
`Sheet 9 of 13
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`1004
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`
`
`
`U.S. Patent
`U.S. Patent
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`Sep. 25, 2012
`Sep. 25, 2012
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`Sheet 10 of 13
`Sheet 10 of 13
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`US 8,273,053 B2
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`

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`U.S. Patent
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`Sep. 25, 2012
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`Sheet 11 of 13
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`U.S. Patent
`U.S. Patent
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`Sep. 25, 2012
`Sep. 25, 2012
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`Sheet 12 of 13
`Sheet 12 of 13
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`US 8,273,053 B2
`US 8,273,053 B2
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`U.S. Patent
`U.S. Patent
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`Sep. 25, 2012
`Sep. 25, 2012
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`Sheet 13 of 13
`Sheet 13 of 13
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`US 8,273,053 B2
`US 8,273,053 B2
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`US 8,273,053 B2
`
`1
`PATIENT STATUS SENSOR
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This application claims the benefit under 35 U.S.C. §119
`(e) to U.S. Provisional Patent Application No. 61/175,746,
`filed May 5,2009, titled “PATIENT STATUS SENSOR FOR
`INTRAOSSEOUS DRUG DELIVERY SYSTEM,” which is
`hereby incorporated by reference herein in its entirety.
`
`BACKGROUND
`
`1. Field
`The present disclosure relates to apparatus, methods, and
`systems for monitoring status of a patient.
`2. Description of Related Art
`Treatment of victims of traumatic injuries requires swift
`action. There are often many casualties, and each patient
`often requires the administration of large amounts of fluids,
`blood products and medications in the first few minutes to
`survive. On the battlefield and in traumatic crashes, access to
`traditional sites on patients for the insertion of intravenous
`lines may be difficult or even impossible due to damage to
`peripheral sites (e.g., arms, legs). The use of large veins such
`as the jugular is difficult and introduces a high rate of com­
`plicating issues in addition to the difficulty of safe mechanical
`fixation of the components involved. Other difficulties can
`occur.
`Monitoring of patients in large-scale emergency medical
`situations such as mass transit accidents, terror attacks, or
`battlefields is often difficult due to the limitations on the
`numbers of medical personnel and equipment. There are
`often far too few devices to monitor all of the victims and even
`fewer personnel making it impossible for each patient to be
`continuously supervised. Speed in assessing and preparing
`patients can be important for introducing fluids and medica­
`tion to the patient as well as setting up diagnostic and moni­
`toring equipment. Complicated attachment of standard
`equipment and devices designed for hospital use such as, e.g.,
`fluid lines and vital signs sensors may take too much time in
`these situations.
`
`SUMMARY
`
`In view of the aforementioned and other limitations,
`improvements in apparatus, systems, and methods for moni­
`toring and treating patients, particularly trauma patients, are
`desirable. For example, certain embodiments provide an
`easy-to-use, disposable, single-use patient status sensor (e.g.,
`a “patch” sensor) that can be applied to trauma patients (e.g.,
`accident victims, victims of natural disasters, battlefield or
`terror casualties, ICU or emergency room patients, etc.). The
`patient status sensor can include visual or audible indicators
`that allow medical personnel to tell at a glance the condition
`or vital signs of the patient, e.g., the respiration rate and/or
`heart rate of the patient. Certain embodiments can be config­
`ured for use with intraosseous (IO) delivery systems that
`deliver fluids to bone marrow of the patient. Certain embodi­
`ments can include wired or wireless (e.g., radio frequency or
`frequency modulated audio signals) components to commu­
`nicate vital signs or patient status information from the
`patient status sensor to external monitoring devices.
`Certain embodiments of the patient status sensor, with or
`without IO infusion components, can be readily applied to a
`patient or trauma victim to provide a quick visual indication
`of the patient’s vital signs (e.g., respiration and heart rate or
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`other vital signs) and perform any calculations or processing
`for determining the vital signs on the patient status sensor
`itself (e.g., via a processor on the sensor). Certain such
`embodiments do not include components for wired and/or
`wireless communication of vital signs or other sensor data
`“off’ the patient status sensor in order to provide an inexpen­
`sive, lightweight sensor that is less likely to fail in trauma
`situations. Other embodiments can include wired and/or
`wireless communication components.
`Many vital signs are available with relatively large signal
`strength or convenient access in the chest and sternal area.
`Examples include, but are not limited to, ECG, respiration,
`blood pressure, core body temperature, glucose, pH, and
`blood oxygen. In some embodiments, an IO needle assembly
`can be used to insert a bone portal through a bone. One or
`more sensors (e.g., temperature, pressure) integrated with the
`bone portal provide direct access to the core body temperature
`as well as fluid pressures that are related to the patient’s blood
`pressure. Access to blood and blood-borne fluids via the bone
`portal provide the capability, in some embodiments, to mea­
`sure, for example, blood oxygen content, pH, and/or glucose.
`The system electronics of embodiments of the disclosed
`patient status sensor can be used to monitor output from such
`sensors and to use the sensor information, at least in part, to
`determine patient status. In some embodiments, other para­
`metric sensors can be incorporated with the portal or the
`patient status sensor.
`An embodiment of an intraosseous (IO) fluid delivery and
`patient status system is provided. The IO system comprises an
`IO infusion device configured to provide access to an IO
`space in a bone of a patient. The IO infusion device comprises
`a bone portal that comprises a fluid delivery channel. The
`bone portal has a proximal end and a distal end. The distal end
`is configured to be inserted into the bone. For example, the
`distal end of the bone portal can be configured to be inserted
`into the sternum or a long bone (e.g., tibia, humerus) of the
`patient. The IO infusion device further comprises a fluid
`delivery conduit configured to be coupled to the proximal end
`of the bone portal so as to provide fluid access to the fluid
`delivery channel of the bone portal. The IO system also com­
`prises a patient status sensor configured to monitor at least
`one vital sign of the patient. The patient status sensor includes
`a flexible substrate that comprises an adhesive component
`configured to adhere the patient status sensor to the patient.
`The patient status sensor also includes a plurality of elec­
`trodes disposed in or on the substrate and configured to
`receive an electrical signal from the body of the patient and in
`response to provide a body signal. The patient status sensor
`also includes a visual indicator and a power source configured
`to be electrically connected to the visual indicator and a
`processor. The processor can be configured to (a) receive and
`process the body signal from the plurality of electrodes in
`order to determine a measurement of a vital sign, (b) deter­
`mine patient status based at least in part on the measurement
`of the vital sign and one or more vital sign limits, and (c)
`output a patient status signal to the visual indicator. The visual
`indicator can be configured to output visual information
`indicative of the patient status.
`An embodiment of a patient status sensor configured to
`monitor at least heart beat and respiration of a patient is
`provided. The patient status sensor comprises a flexible sub­
`strate that includes an adhesive layer configured to adhere the
`patient status sensor to the patient. The patient status sensor
`also comprises a visual indicator disposed in or on the sub­
`strate and a plurality of electrodes disposed in or on the
`substrate. The patient status sensor can be configured to out­
`put an impedance signal via the plurality of electrodes to the
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`US 8,273,053 B2
`
`3
`body of the patient. The plurality of electrodes can be con­
`figured to receive from the body of the patient an electrical
`signal comprising an electrocardiogram (ECG) signal and a
`modulation of the impedance signal. The patient status sensor
`also comprises a processor disposed in or on the substrate,
`and the processor can be configured to: receive and process
`the electrical signal to determine a measurement of heart rate
`from the ECG signal and respiration rate from the modulation
`of the impedance signal; determine patient status based at
`least in part on (a) the measurement of the heart rate and one
`or more heart rate limits and (b) the measurement of the
`respiration rate and one or more respiration rate limits; and
`output a patient status signal to the visual indicator in
`response to the determination of the patient status. The visual
`indicator can be configured to output visual information
`indicative of at least one of the heart rate, the respiration rate,
`and the patient status. The patient status sensor can also
`comprise a power source disposed in or on the substrate. The
`power source can be configured to be electrically connected
`to the plurality of electrodes, the visual indicator, and the
`processor.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 shows an example of an intraosseous (IO) fluid
`delivery system applied to the sternum of a patient and an
`infusion tube connected to a sternal access portal introduced
`into the sternum of the patient. An infusion fluid can be
`delivered via the tube through a lumen in the sternal access
`portal and into bone marrow.
`FIG. 2 is a top view that schematically illustrates an
`embodiment of a patient status sensor comprising a patch that
`can be used with various embodiments of an IO delivery
`system.
`FIG. 2A schematically illustrates an embodiment of an IO
`delivery system comprising an embodiment of a patient status
`sensor.
`FIG. 3 is a block diagram that schematically illustrates an
`embodiment of circuitry for a patient status sensor. The cir­
`cuitry can process body signals to determine heart rate
`(among other vital signs) and to determine patient status
`based at least in part on the heart rate (or other vital signs).
`FIG. 4 is an example of a graphical user interface that can
`be displayed on a monitoring device to indicate vital signs and
`patient status.
`FIG. 5 is a block diagram that schematically illustrates an
`embodiment of circuitry for a patient status sensor compris­
`ing a pressure sensor and a temperature sensor that can be
`integrated or used with IO delivery components.
`FIG. 6 is a top view that schematically illustrates an
`embodiment of a standalone patient status sensor.
`FIG. 7 is a block diagram that schematically illustrates an
`embodiment of circuitry for a patient status sensor. The cir­
`cuitry can process body signals to determine heart rate and
`respiration rate (among other vital signs) and determine
`patient status based at least in part on the heart rate and
`respiration rate (or other vital signs).
`FIG. 8 is a flowchart schematically illustrating an example
`of a process that can be used by the circuitry of a patient status
`sensor to provide an indication of patient status.
`FIG. 9 is a block diagram schematically illustrating an
`example of a process for determining respiration rate and
`heart rate (pulse).
`FIG. 10 is a flowchart schematically illustrating an
`example of a method for determining patient status.
`
`4
`FIG. 11 is a flowchart showing an example of a field triage
`decision scheme.
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`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`The following detailed description is directed to certain
`specific embodiments. However, the teachings herein can be
`applied in a multitude of different ways. In this description,
`reference is made to the drawings wherein like parts are
`designated with like numerals throughout.
`Overview of Embodiments of Patient Vital Signs Monitoring
`Systems
`Many traditional monitoring methods and systems for vital
`signs in the field are complicated and may involve the use of
`portable devices weighing several pounds along with mul­
`tiple sensors and cables. In battlefield situations and traumatic
`events, many seriously injured patients may be in the same
`area. Several monitors would be desired when only one is
`present. In addition, several vital signs with individual cables
`and connections must be continuously monitored to deter­
`mine the status of each patient.
`Examples of vital signs that can be measured to monitor
`patient status include: electrocardiogram (ECG or EKG),
`saturation of peripheral oxygen (SpO2), blood pressure, res­
`piration, temperature, heart rate, blood glucose, pH, etc. Cer­
`tain traditional methods and devices for measuring vital signs
`suffer from disadvantages.
`ECG can be used to determine the pulse rate and rhythm as
`well as rhythm abnormalities. ECG measurements may use
`electrodes to pick up the electrical impulses on the skin and
`cables to connect between the electrodes and the patient.
`Many wireless methods can be used to eliminate or reduce
`reliance on cables (for example radio-frequency (RF) tech­
`nologies such as, e.g., Bluetooth or 802.15.4 ZigBee). In
`some cases, wireless methods can have power and interfer­
`ence issues and tend to be rather more expensive than the
`cables they replace. An example is Alive Technologies’ Heart
`Monitor (Arundel Queensland, Australia).
`Temperature sensors may also use cabling. In some imple­
`mentations, temperature sensors do not use the same elec­
`trode sites as ECG since body surface temperature measure­
`ments may have a poor relationship to the body’s internal
`temperature, especially on patients in shock. In some cases, a
`temperature sensor is placed in an alternative anatomical
`location and uses a separate cable or an additional wireless
`component.
`Blood pressure is traditionally measured using an inflat­
`able cuff using either hand-operated or electronic pumps.
`Blood pressure devices may be configured to deliver systolic,
`diastolic and mean pressures along with pulse rate while the
`measurement is being taken. In some implementations, the
`pulse rates measured are periodic, not continuous, since pulse
`rates are measured only when the cuff is deflating. Many such
`units tend to be bulky, use even more power than other sen­
`sors, and use a cuff or mechanism encircling an arm or a leg.
`Access to the appropriate arm or leg site may not be possible
`in trauma situations due to injuries, especially if toumiquet(s)
`have been applied to the patient.
`SpO2 can be measured using pulse oximetry sensors and
`electronics to determine blood oxygen levels and can also
`return a pulse rate and patient peripheral circulation. Nonin
`Medical, Plymouth, Minn., provides wireless pulse oximetry
`products that use Bluetooth wireless technology.
`Respiration can be monitored using several methods
`including, for example, body impedance. In some implemen­
`tations, body impedance can be obtained using the ECG
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`5
`electrodes. Respiration may also be monitored using other
`technology utilizing a separate connection or cable.
`These traditional methods generally use a patient monitor­
`ing device to collect and display the vital signs obtained from
`sensors. The monitoring device can be a battery powered
`device with a display large enough for good viewing at an
`appropriate distance. The physician or paramedic views the
`display and interprets multiple waveforms and measurements
`or listens to the audible sounds (e.g., beeping) to determine
`the status of the patient.
`An example of a patient monitoring system is the Propaq®
`LT monitor available from Welch Allyn Protocol Systems
`(Skaneateles Falls, N.Y.). The Propaq monitor can be used in
`military and EMS applications to monitor trauma patients and
`has multiple channels of ECG along with temperature, blood
`pressure, and pulse oximetry.
`While certain vital signs monitoring systems are certainly
`useful in some situations, the systems are typically large, use
`multiple connections, have large displays, lots of cabling, and
`deliver a complex display that may be difficult to interpret
`quickly to assess the basic status of a trauma patient. Moni­
`toring systems using wireless communication technology
`exist but wireless communication may add expense and com­
`plexity. It may be too expensive for emergency medical per­
`sonnel to have enough of these monitors for large-scale trau­
`matic accidents. These monitors may take significant time to
`connect to a patient and properly configure. Even when prop­
`erly set up, many of these monitors require significant train­
`ing to use and constant observation to obtain the status of a
`given patient. Various embodiments of the systems and
`devices described herein may address some or all of the above
`challenges and/or other challenges.
`Overview of Intraosseous Systems and Methods
`Intraosseous (IO) fluid delivery systems are used for the
`delivery, injection, or infusion of medications, fluids, or blood
`products, typically directly into the marrow of a bone. IO
`methods typically penetrate long bone or sternal bone by
`introduction of a hollow bone portal into the marrow space.
`IO infusion or delivery systems can provide rapid vascular
`access for fluid and drug infusion in patients, for example,
`shock and trauma victims and can be an alternative to con­
`ventional intravenous and central lines. IO systems may also
`provide associated connections and tubing and mechanical
`fixation for the tubing. For example, a portion of the IO
`delivery system may be secured to the patient’s skin with an
`adhesive system. IO systems can be used in trauma or battle­
`field conditions where traditional patient monitoring devices
`can be used to monitor vital signs such as, e.g., pulse, ECG,
`blood pressure, temperature, and other patient parameters are
`not accessible or are difficult to use. IO systems may be used
`to deploy high drug concentrations quickly into the central
`circulation.
`Certain IO access and delivery products are available. For
`example, the EZ-IO® System is available from Vidacare Cor­
`poration (San Antonio, Tex.), and the FASTI® or FASTx™
`Intraosseous Infusion System is available from Pyng Medical
`Corporation (Richmond BC, Canada). Sternal IO may be an
`advantageous method of access in traumatic injury due to
`inaccessible or non-patent peripheral access. Limbs may be
`injured or amputated, and traumatic conditions like shock can
`make it difficult to start IV access. In some implementations,
`sternal access can involve inserting a bone portal through the
`bone to provide access to the marrow. For example, fluid can
`be delivered through an infusion tube attached to a proximal
`end of the bone portal. The fluid can flow through a delivery
`channel in the bone portal (e.g., a lumen or bore) and into the
`highly perfused marrow and subsequently into the blood
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`US 8,273,053 B2
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`6
`stream. For example, the Pyng FASTI® or FASTx systems
`use a mechanical introducer to place a bone portal into the
`sternal bone marrow space. The bone portal delivery system
`can be used with an adhesive patch to configured to assist a
`medical attendant in positioning the bone portal in a desired
`location on the bone (e.g., between the xyphoid process and
`the sternal notch). The Vidacare EZ-IO® system generally
`provides access into the marrow space of long bones (e.g.,
`tibia, humerus) usin