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`US 20040149282Al
`
`(19) United States
`(12) Patent Application Publication
`Hickle
`
`(10) Pub. No.: US 2004/0149282 Al
`Aug. 5, 2004
`( 43) Pub. Date:
`
`(54) RESPIRATORY MONITORING SYSTEMS
`AND METHODS
`
`(52) U.S. Cl. ........................................................ 128/203.14
`
`(75)
`
`Inventor: Randall S. Hickle, Lubbock, TX (US)
`
`(57)
`
`ABSTRACT
`
`Correspondence Address:
`HOGAN & HARTSON LLP
`IP GROUP, COLUMBIA SQUARE
`555 THIRTEENTH STREET, N.W.
`WASHINGTON, DC 20004 (US)
`
`(73) Assignee: Scott Laboratories, Inc.
`
`(21) Appl. No.:
`
`10/724,870
`
`(22) Filed:
`
`Dec. 2, 2003
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/430,088, filed on Dec.
`2, 2002.
`
`Publication Classification
`
`(51)
`
`Int. Cl.7 .................................................... A61M 15/00
`
`The present invention includes a respiratory monitor that
`improves patient safety through the use of highly responsive
`monitors and displays highly visible to all clinical personnel
`even in the absence or failure of an alarm display. The
`display can be positioned so that clinicians do not have to
`look away from the patient to view the output of the
`respiratory monitor. The respiratory monitoring system
`alerts clinicians of potential problems while automatically
`taking steps to gather additional information and place an
`integrated drug delivery system in a safe state (e.g., step
`down or deactivation) in addition to providing a real-time
`visual indicator of respiratory rate and estimated tidal vol(cid:173)
`ume or respiratory effort and effect. Multiple thresholds that
`trigger corresponding indicators such as color-coded LEDs
`provide a quantized display of respiratory effort and effect
`while also providing a certain level of redundancy. The
`respiratory effort and effect can also be displayed by the
`intensity of the LEDs. Other arrays of LEDS provide graded
`levels of alarms.
`
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`Patent Application Publication Aug. 5, 2004 Sheet 7 of 9
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`Patent Application Publication Aug. 5, 2004 Sheet 8 of 9
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`NU MARK Ex.1006 p.9
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`Patent Application Publication Aug. 5, 2004 Sheet 9 of 9
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`US 2004/0149282 Al
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`Establish First Alarm
`Parameters
`
`Establish Second Alarm
`Parameters
`
`Establish Third Alarm
`Parameters
`
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`NU MARK Ex.1006 p.10
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`US 2004/0149282 Al
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`Aug. 5, 2004
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`1
`
`RESPIRATORY MONITORING SYSTEMS AND
`METHODS
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application claims priority under 35 U.S.C.
`§119(e) to U.S. Provisional Patent Application No. 60/430,
`088, "Respiratory Monitoring Systems and Methods," filed
`Dec. 2, 2002, which is hereby incorporated by reference.
`
`STATEMENT REGARDING FEDERALLY
`SPONSORED RESEARCH OR DEVELOPMENT
`
`[0002] Not Applicable
`
`REFERENCE TO A "MICROFICHE APPENDIX"
`
`[0003] Not Applicable
`
`BACKGROUND OF THE INVENTION
`
`[0004] 1. Field of the Invention
`
`[0005] The present invention relates, in general, to respi(cid:173)
`ratory monitoring and, more particularly, to respiratory
`monitoring associated with medical devices.
`
`[0006] 2. Description of the Related Art
`
`[0007] Every year a significant number of patients suffer
`severe complications or death due to inadequate, improper
`or inaccurate respiratory monitoring. Unaided by sensors, it
`is difficult in some critical circumstances, for even the most
`highly trained clinician to ascertain whether a patient is
`moving sufficient air or gas for proper alveolar gas
`exchange. In an attempt to improve patient safety, a number
`of respiratory monitoring systems have been developed.
`However, such systems have not fully met the safety needs
`of patients, particularly in settings such as sedation and
`analgesia of the conscious and/or spontaneously breathing
`patient, as evidenced by continuing reports of negative
`patient episodes due to inadequate, improper or inaccurate
`respiratory monitoring.
`
`[0008] Capnometry systems have been used with some
`success in assessing the respiration of a patient by evaluating
`the partial pressure or percent concentration of exhaled
`carbon dioxide. When using these systems, carbon dioxide
`production is implicitly correlated to oxygen consumption
`via the respiratory quotient, which usually has a value of 0.8.
`Mainstream capnometers consist of a small infrared gas
`analysis bench that is mounted directly in the patient's
`respiratory path providing real-time information regarding
`the C02 level in the patient's respiration. However, the
`sampling cell used by mainstream capnometers is, in gen(cid:173)
`eral, relatively bulky and heavy. The sample cell of a
`mainstream capnometer can be in the way when mounted in
`the respiratory path, e.g., in front of a patient's face. Side(cid:173)
`stream capnometers have a pump that continuously aspirates
`gas samples from the patient's respiratory path, typically at
`a sampling flow rate of about 200 ml/min, via a sampling
`tube that carries the sample gas to a gas analysis bench. The
`finite transport time from the sampling site to the gas
`analysis bench introduces an undesirable time lag. When a
`patient stops breathing, the measured and displayed C02
`level becomes a fiat line at zero mm Hg because there are no
`exhalations containing C02 . Further, a patient's inhalation
`generally draws room air (0.003% C02) or gas having zero
`
`or negligible carbon dioxide concentration such that the
`inspired C02 is for all intents and purposes zero. Thus, it is
`difficult to instantly know during inspiration whether a
`patient is simply inhaling or has stopped breathing all
`together. The need has therefore arisen for a respiratory
`monitoring system that provides real-time, unambiguous
`and instantaneous information regarding a patient's respira(cid:173)
`tory status and phase of respiration.
`
`[0009] Many current respiratory monitoring systems
`require the use of a face mask, where the mask encapsulates
`the nose and mouth of a patient to create a sealed region.
`Different designs of such systems utilize different sensors
`such as temperature sensors, humidity sensors, and flow
`meters. Many patients may find face masks to be uncom(cid:173)
`fortable and anxiety inspiring. In addition, many procedures
`require oral access (e.g., esophogastroduodenoscopy and
`oral surgery) which makes sealing face masks inapplicable.
`Also, the continuous fresh gas flow from an anesthesia
`machine will dilute the C02 in the additional deadspace
`created by the facemask, resulting in artificially low C02
`levels. On the other hand, existing respiratory monitoring
`systems without a sealed facemask may not provide respi(cid:173)
`ratory data of sufficient clinical accuracy. The need has
`therefore arisen for a respiratory monitor that functions
`independently of a sealed face mask and monitors respira(cid:173)
`tion with sufficient clinical accuracy.
`
`[0010] Existing respiratory monitors are generally inte(cid:173)
`grated with alarm systems, where a clinician is alerted to the
`presence of respiratory compromise by visual and/or audio
`alarms. In an operating or procedure room environment,
`where there are multiple alarm sources and auditory and
`visual stimuli, it may take a while before the attending
`clinician is able to determine the cause of the alarm and take
`appropriate action to remedy the situation. In critical cir(cid:173)
`cumstances, rapid diagnosis and intervention can prevent
`morbid complications. The need has therefore arisen for a
`respiratory monitoring system that simultaneously alerts the
`attending clinician of a potential problem while automati(cid:173)
`cally taking steps to gather additional information and
`placing other aspects of a drug delivery system into a safe
`state.
`
`[0011] Existing alarm algorithms or mechanisms generally
`alert the attending clinician in the event of an alarm condi(cid:173)
`tion. In the event of malfunction of the alarm mechanism
`itself, e.g., failure of the buzzer for an audible alarm or the
`LED (light emitting diode) for a visual alarm, an alarm will
`not be generated even though a critical patient condition is
`present. The lack of an alarm may lull the clinician into a
`false sense of security, rendering it even more difficult for
`the clinician to detect the critical patient condition and take
`timely corrective action. The need has therefore arisen for an
`alarm and monitoring system that provides real-time moni(cid:173)
`toring of respiration throughout the duration of a procedure,
`where a clinician may still be able to readily ascertain
`whether respiration has been compromised, even in the
`absence or failure of an alarm mechanism.
`
`[0012] False negative alarm conditions may occur with
`existing respiratory monitoring systems; that is, respiratory
`compromise may be present while no alarm is generated to
`alert the clinician of this condition. For example, existing
`alarms may be set to warn the clinician if a patient does not
`take a sufficient number of substantial breaths within a
`
`NU MARK Ex.1006 p.11
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`

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`US 2004/0149282 Al
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`Aug. 5, 2004
`
`2
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`pre-determined time window. By taking shallow but fre(cid:173)
`quent breaths, it may be possible for a patient to meet or
`exceed the fixed and individual alarm threshold for each
`monitored parameter such that no alarm is generated even
`though respiration is compromised. The need has therefore
`arisen for a respiratory monitoring system that provides
`anthropomorphic, hierarchic and graded alarms based on
`varying patient conditions, where, for example, one tier of
`alarms may be correlated to patient conditions that require
`increased watchfulness and a second tier of alarms may be
`correlated to more serious patient conditions that require
`deactivation of drug delivery. An anthropomorphic alarm
`paradigm is generally less rigid and more context sensitive
`because it attempts to emulate human behavior, mental
`processes and experience. The need has further arisen for a
`respiratory monitoring system that provides a real-time
`visual indicator of respiratory rate and estimated tidal vol(cid:173)
`ume.
`
`SUMMARY OF THE INVENTION
`
`[0013] The present invention satisfies the above needs by
`providing a respiratory monitor that improves patient safety
`in the absence of a sealed face mask. The present invention
`further provides an integrated respiratory monitor with addi(cid:173)
`tional patient monitors and drug administration systems,
`where the integrated system automatically converts the
`system to a safe state in the event of a significant respiratory
`compromise. The present invention even further provides a
`respiratory monitoring system that operates in real time to
`allow for immediate responses to critical patient episodes.
`The present invention also provides a respiratory monitoring
`system that displays real-time information related to a
`patient's respiratory condition and uses anthropomorphic
`and safety-biased alarm and intervention paradigms to mini(cid:173)
`mize distracting alarms and time and motion expenditure.
`The present invention further provides a respiratory monitor
`integral with an alarm and visual monitoring system that has
`a high degree of visibility, where a number of attending
`clinicians can easily monitor real-time information related to
`a patient's respiratory condition.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`[0014] FIG. 1 illustrates a block diagram depicting one
`embodiment of a respiratory monitoring system for use with
`a sedation and analgesia system in accordance with the
`present invention;
`
`[0015] FIG. 2 illustrates a block diagram of a more
`detailed view of one embodiment of a respiratory monitor(cid:173)
`ing system in accordance with the present invention;
`
`[0016] FIG. 3 illustrates one embodiment of a nasal
`interface in accordance with the present invention;
`
`[0017] FIG. 4 illustrates one embodiment of an ear mount
`in accordance with the present invention;
`
`[0018] FIG. 5 illustrates one embodiment of a support
`band in accordance with the present invention;
`
`[0019] FIG. 6 illustrates one embodiment of a method for
`pressure waveform analysis and segmentation depicting
`positive pressure thresholds and negative pressure thresh(cid:173)
`olds in accordance with the present invention;
`
`[0020] FIG. 7 illustrates one embodiment of an LED
`display in accordance with the present invention;
`
`[0021] FIG. 8 illustrates one embodiment of a method for
`employing a respiratory monitoring system in accordance
`with the present invention; and
`
`[0022] FIG. 9 illustrates one embodiment of a method for
`employing a respiratory monitoring system having alarm
`conditions in accordance with the present invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0023] FIG. 1 illustrates a block diagram depicting one
`embodiment of the present invention comprising a sedation
`and analgesia system 22 having user interface 12, software
`controller 14, peripherals 15, power supply 16, external
`communications 10, respiratory monitoring 11, 0 2 delivery
`9 with manual bypass 20 and scavenger 21, patient interface
`17, and drug delivery 19, where sedation and analgesia
`system 22 is operated by user 13 in order to provide sedation
`and/or analgesia to patient 18. Several embodiments of
`sedation and analgesia system 22 are disclosed and enabled
`by U.S. patent application Ser. No. 09/324,759, filed Jun. 3,
`1999 and incorporated herein by reference in its entirety. It
`is further contemplated that respiratory monitoring 11 be
`used in cooperation with sedation and analgesia systems,
`anesthesia systems and integrated patient monitoring sys(cid:173)
`tems, independently, or in other suitable capacities. Embodi(cid:173)
`ments of patient interface 17 are disclosed and enabled by
`U.S. patent application Ser. No. 09/592,943, filed Jun. 12,
`2001 and U.S. patent application Ser. No. 09/878,922 filed
`Jun. 13, 2001 which are incorporated herein by reference in
`their entirety.
`
`[0024] FIG. 2 illustrates a block diagram depicting a more
`detailed view of one embodiment of respiratory monitoring
`11, controller 14, drug delivery 19, and patient interface 17.
`In one embodiment of the present invention, patient inter(cid:173)
`face 17 comprises nasal cannula 30 and visual display 31.
`Nasal cannula 30 may deliver oxygen to patient 18, sample
`the partial pressure or percent concentration of carbon
`dioxide, and sample nasal pressure associated with inhala(cid:173)
`tion and exhalation. Visual display 31 may be a series of
`light emitting diodes (LEDs) capable of visually displaying
`information related to patient respiration. The LEDs may be
`designed to be reusable with disposable covering lenses. The
`disposable covering lenses may be designed to amplify the
`intensity of the LEDs and may also be of shapes (such as
`arrows or arrowheads) that indicate the direction of gas flow
`during inhalation and exhalation.
`
`[0025] Respiratory monitoring 11 may comprise sensor
`32, analog digital input output (ADIO) device 29, and
`computer programmable logic device (CPLD) 33. Sensor 32
`may be a pressure sensor, a humidity sensor, a thermistor, a
`flow meter, or any other suitable sensor for measuring
`respiration of patient 18. In one embodiment of the present
`invention, sensor 32 is a Honeywell DC series differential
`pressure sensor capable of monitoring from + 1 inch to -1
`inch of water pressure. The present invention comprises a
`plurality a sensors that may be associated with individual
`nares, oral monitoring, both nasal and oral monitoring,
`intra-vascular monitoring, or other means of employing
`sensors commonly known in the art.
`
`[0026] Still referring to FIG. 2, respiratory monitoring 11
`further comprises tubing 34 which interfaces with cannula
`30 and sensor 32 in order to measure the pressure variations
`
`NU MARK Ex.1006 p.12
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`3
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`caused by respiration of patient 18. Tubing 34 may be
`constructed of any suitable material for providing sensor 32
`with accurate pressure measurements from cannula 30 such
`as, for example, polyvinyl tubing. The characteristics of
`tubing 34 such as internal diameter, wall thickness and
`length may be optimized for transmission of the pressure
`signal. Sensor 32 may output analog signals, where ADIO
`device 29 converts the analog signals to digital signals
`before they are transmitted to controller 14 via connection
`36. Controller 14 may process the digital signals into res(cid:173)
`piratory information. Digital signals relating to patient res(cid:173)
`piration may then be transmitted via connection 38 to CPLD
`33, where programming associated with CPLD 33 then
`controls visual display 31 via connection 39 based on the
`information contained in the digital signals. In some
`embodiments of the invention, any of controller 14, ADIO
`29, CPLD 33, and sensor 32 may be included or excluded in
`different combinations or permutations on a single inte(cid:173)
`grated circuit.
`
`[0027]
`In one embodiment of the present invention, con(cid:173)
`troller 14 may control drug delivery 19 based on data
`received from ADIO device 29, where such data indicates a
`potentially dangerous patient episode. Controller 14 may be
`programmed to deactivate drug delivery 19 or reduce drug
`delivery rate associated with drug delivery 19 in the event of
`a negative patient episode, or reactivate drug delivery upon
`receipt of data indicating that patient 18 is no longer
`experiencing a potentially life-threatening event.
`
`[0028] FIG. 3 illustrates one embodiment of nasal inter(cid:173)
`face 40 associated with cannula 30 (FIG. 2). In one embodi(cid:173)
`ment of the present invention, nasal interface 40 comprises
`first nasal port 41, second nasal port 42, oxygen delivery port
`44, first nasal capnography port 48, first pressure sensor port
`43, second nasal capnometry port 47, second pressure sensor
`port 45, oral capnometry port 49, and oral port 46. First nasal
`port 41 and second nasal port 42 may be designed for
`placement within or adjacent to the nares of patient 18. An
`in-house or portable oxygen supply may be connected to
`oxygen delivery port 44, such that oxygen may be delivered
`to patient 18 through first nasal port 41 and second nasal port
`42 or a grid of ports.
`
`[0029] Embodiments of the present invention may com(cid:173)
`prise monitoring a single nare of patient 18, monitoring
`multiple nares in the absence of an oral monitor, monitoring
`patient 18 orally in the absence of nasal monitors, or other
`suitable monitoring combinations. Oxygen delivery may be
`optional, orally delivered, nasally delivered, or delivered
`both orally and nasally. The present invention further com(cid:173)
`prises a plurality of oxygen delivery ports, where oxygen
`may be delivered to the nares and/or mouth. It is further
`consistent with the present invention to deliver a plurality of
`gases through nasal interface 40 such as, for example,
`nitrous oxide. A further embodiment of the present invention
`comprises monitoring a plurality of patient parameters such
`as, for example, inspired and/or expired oxygen and/or C02
`concentration or partial pressure via nasal interface 40.
`
`[0030] Still referring to FIG. 3, nasal interface 40 may be
`constructed from nylon, acrylonitrile butadiene styrene
`(ABS), acrylic, poly-carbonate, or any other suitable mate(cid:173)
`rial for use in medical devices. It is further consistent with
`the present invention to monitor C02 , respiratory rate,
`respiratory volume, respiratory effort and other patient
`
`parameters in the absence of nasal interface 40, where
`monitoring may be intracorporeal or extracorporeal. The
`present invention further comprises tubing (not shown)
`associated with the ports of nasal interface 40, where the
`tubing may connect nasal interface 40 to a plurality of
`sensors, gas delivery systems, and/or other suitable periph(cid:173)
`erals. The tubing may be constructed out of nylon, polyvi(cid:173)
`nyl, silicon, or other suitable materials commonly known in
`the art.
`
`[0031] FIG. 4 illustrates one embodiment of ear mount 54
`of visual display 31(FIG.2). LEDs may be mounted on ear
`mount 54 which may be adapted for placement on the ear or
`ears of patient 18. Ear mount 54 comprises stalk 50, base 51,
`support 52, first interfacing surface 53, and second interfac(cid:173)
`ing surface 55. First interfacing surface 53 may be partially
`or completely covered in a cushioning surface (not shown),
`where the cushioning surface is the surface that will come
`into direct contact with the ear of patient 18. The cushioning
`surface may be constructed from foam, padded vinyl, or any
`other material suitable for providing patient comfort. In one
`embodiment of the present invention, second interfacing
`surface 55 interfaces with LED display 60 (described below
`with respect to FIG. 7).
`
`[0032] Stalk 50 may be detachably connectable to clasp 57
`of support band 58 or permanently affixed to clasp 57
`(described below with respect to FIG. 5). Clasp 57 may be
`a snap fit clasp or any other suitable clasp commonly known
`in the art. Stalk 50 may be adjustable and/or flexible and/or
`malleable to provide optimal patient comfort. Ear mount 54
`may be constructed from ABS, polycarbonate, or any other
`suitable material commonly known in the art.
`
`[0033] FIG. 5 illustrates one embodiment of support band
`59, which comprises support member 58, clasp 57, and
`comfort band connector 56. Support band 59 may be
`designed to be detachably removable from ear mount 54
`(FIG. 4). Support band 59 may be a head band, where
`support band 59 is designed to fit snugly around the head of
`patient 18. Support band 59 may be constructed from any
`suitable material commonly known in the art, however
`flexible materials such as, for example, poly-carbonate,
`silicon, or nylon are preferable. Positioning support band 59,
`ear mount 54, and LED display 60 (FIG. 7) in the cranial
`region of patient 18 provides user 13 with a display of high
`visibility. Support band 59 may be designed to carry a
`plurality of ear mounts 54 placed on each ear of patient 18.
`Due to the significant number of procedures requiring
`patients to lie on their sides, the present invention comprises
`mounting ear mount 54 over one or both ears. Placing LED
`display 60 in the cranial region of patient 18 allows user 13
`to visually monitor LED display 60 and the respiratory
`parameters of patient 18 visible to the naked eye simulta(cid:173)
`neously. The present invention further comprises adapting
`support band 59 to fit any portion of the body of patient 18,
`adapting support band 59 for placement on existing medical
`equipment such as, for example, bed rails, and/or adapting
`support band 59 to fit on user 13, such as, for example, in the
`form of a bracelet.
`
`[0034] LED display 60 may be utilized in the absence of
`ear mount 54 and/or support band 59, where LED display 60
`is positioned at any suitable location on the body of patient
`18, at any suitable location in the operating room, or at any
`suitable location on the body of user 13. LED display 60
`
`NU MARK Ex.1006 p.13
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`Aug. 5, 2004
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`4
`
`may be integrated with a bracelet, an adhesive for attach(cid:173)
`ment to existing medical structures, or placed in a remote
`location for remote monitoring. One embodiment of LED
`display 60 is further disclosed in FIG. 7.
`
`[0035] FIG. 6 illustrates one embodiment of a method for
`pressure waveform analysis and segmentation in accordance
`with the present invention. Pressure waveform 75 comprises
`positive pressure region 76, negative pressure region 77, and
`zero pressure axis 78. FIG. 6 illustrates one full tidal breath
`of patient 18, where positive pressure region 76 correlates
`with exhalation and negative pressure region 77 correlates
`with inhalation. Pressure waveform 75 is at, or close to, the
`zero pressure axis 78 during the transition from exhalation
`to inhalation and inhalation to exhalation.
`[0036] The present invention comprises establishing a
`series of predetermined positive pressure thresholds 79, 80,
`81, 82, 83, 84 and a series of predetermined negative
`pressure thresholds 85, 86, 87, 88, 89, 90. As patient 18
`inhales and exhales, controller 14 will ascertain which of the
`predetermined thresholds 79, 80, 81, 82, 83, 84, 85, 86, 87,
`88, 89, 90 has been exceeded by the respiratory pressure
`waveform 75. Information relative to magnitude of pressure
`change associated with inspiration and expiration will then
`be routed from controller 14 to LED display 60, where
`specific LEDs associated with corresponding predetermined
`thresholds will illuminate. Exhalations and inhalations of a
`low magnitude will result in a minimal number of LEDs
`lighting, whereas exhalations and inhalations of a high
`magnitude will result in a greater number of LEDs lighting.
`By placing LED display 60 in a highly visible area, user 13
`or other attending clinicians may visually monitor the res(cid:173)
`piratory condition of patient 18 in a semi-quantitative man(cid:173)
`ner. Any suitable number of predetermined thresholds 79,
`80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90 may be set at a
`plurality of pressure levels suitable for a particular patient 18
`or application. The present invention further comprises
`associating positive pressure thresholds 79, 80, 81, 82, 83,
`84 with LEDs 61, 62, 63, 64, 65, 66 (FIG. 7), where LEDs
`61, 62, 63, 64, 65, 66 are of a particular color such as, for
`example, blue or gray. The present invention further com(cid:173)
`prises associating negative pressure thresholds 85, 86, 87,
`88, 89, 90 where LEDs 68, 69, 70, 71, 72, 73 are of a
`particular color different from that associated with exhala(cid:173)
`tion LEDs 67 such as, for example, green. Providing vari(cid:173)
`able color for patient 18 inhalation and exhalation allows
`user 13 to ascertain at a glance whether patient 18 is inhaling
`or exhaling, and the pressure magnitude associated with the
`exhalation or inhalation.
`[0037] The present invention further comprises establish(cid:173)
`ing alarm parameters within controller 14, where if the
`inhalations or exhalations of patient 18 do not exceed
`predetermined pressure thresholds for a predetermined
`period of time, controller 14 may initiate an alarm condition.
`In the event of an alarm condition, controller 14 may be
`programmed to display evidence of the alarm or potentially
`dangerous patient episode via a series of LEDs 91, 92, 93
`associated with LED display 60. For example, first series of
`LEDs 91 may correlate to a warning condition, second series
`of LEDs 92 may correlate to a more significant warning
`condition, and third series of LEDs 93 may correlate to yet
`a more significant warning condition.
`[0038] FIG. 7 illustrates one embodiment of LED display
`60 in accordance with the present invention comprising first
`
`exhalation LED 61, second exhalation LED 62, third exha(cid:173)
`lation LED 63, fourth exhalation LED 64, fifth exhalation
`LED 65, and sixth exhalation LED 66, collectively referred
`to as exhalation LEDs 67. LED display 60 further comprises
`first inhalation LED 68, second inhalation LED 69, third
`inhalation LED 70, fourth inhalation LED 71, fifth inhala(cid:173)
`tion LED 72, and sixth inhalation LED 73, collectively
`referred to as inhalation LEDs 74. LED display 60 further
`comprises first series of LEDs 91, second series of LEDs 92,
`third series of LEDs 93, and base 94. In one embodiment of
`the present invention, base 94 is affixed to ear mount 54,
`where LEDs associated with LED display 60 face away
`from patient 18. However, it is contemplated that base 94 be
`constructed from flexible material or rigid material where
`base 94 may be placed in any suitable highly visible loca(cid:173)
`tion.
`
`In one embodiment of the present invention, first
`[0039]
`exhalation LED 61 corresponds to positive pressure thresh(cid:173)
`old 79, where an exhalation that exceeds first positive
`pressure threshold 79 will result in first exhalation LED 61
`lighting. Second exhalation LED 62 corresponds to second
`positive pressure threshold 80, where an exhalation that
`exceeds second positive pressure threshold 80 will result in
`both first exhalation and second exhalation LEDs 61, 62
`lighting. LEDs corresponding to predetermined thresholds
`will additively light in the above described fashion, where
`third exhalation LED 63 corresponds to third positive pres(cid:173)
`sure threshold 81, fourth exhalation LED 64 corresponds to
`fourth positive pressure threshold 82, fifth exhalation LED
`65 corresponds to fifth positive pressure threshold 83, and
`sixth exhalation LED 66 corresponds to sixth positive pres(cid:173)
`sure threshold 84.
`
`[0040] The present invention further comprises providing
`inhalation LEDs 74 where first inhalation LED 68 corre(cid:173)
`sponds to negative pressure threshold 85, where an inhala(cid:173)
`tion that exceeds first negative pressure threshold 85 will
`result in first inhalation LED 68 lighting. Second inhalation
`LED 69 corresponds to second negative pressure threshold
`86, where an inhalation that exceeds second negative pres(cid:173)
`sure threshold 86 will result in both first inhalation and
`second inhalation LEDs 68, 69 lighting. LEDs correspond(cid:173)
`ing to predetermined thresholds will additively light in the
`above described fashion, where third inhalation LED 70
`corresponds to third negative pressure threshold 87, fourth
`inhalation LED 71 corresponds to fourth negative pressure
`threshold 88, fifth inhalation LED 72 corresponds to fifth
`negative pressure threshold 89, and sixth inhalation LED 73
`corresponds to sixth negative pressure threshold 90.
`
`[0041] The thresholds 79-90 may be absolute or relative
`values. For example, for a pressure sensor where 0 output
`voltage represents zero or ambient pressure, each threshold
`may be fixed at a set voltage representing a given pressure
`level. With a bi-polar, linear pressure sensor where each inch
`of water pressure is 10 volts of output voltage and 0 V
`represents ambient (zero) pressure, a first threshold may be
`set at +0.1 V representing a pressure threshold of 0.01" of
`water. However if the zero output voltage drifts on the
`pressur