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`Approved for use through10/31/2002. OMB 0651-0032
`U.S. Patent and Trademark Office, U.S DEPARTMENT OF COMMERCE
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`PROVISIONAL APPL/CATION FOR PA TENT COVER SHEET
`This is a reauest for filina a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).
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`f->
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`ID
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`INVENTOR(S)
`
`Given Name (first and middle [if any])
`
`Family Name or Surname
`
`Residence
`(City and either State or Foreign Country)
`
`Randall S.
`
`HICKLE
`
`Lubbock, Texas
`
`D
`
`Additional inventors are being named on the
`
`separately numbered sheets attached hereto
`
`TITLE OF THE INVENTION (500 characters max)
`
`RESPIRATORY MONITORING SYSTEMS AND METHODS
`
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`82021-0033
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`USE-ONLY FOR FILING A PROVISIONAL APPL/CATION FOR PA TENT
`This collection of information is required by 37 CFR 1.51. The information is used by the public to file (and by the PTO to process) a
`provisional application Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 8 hours to
`complete, including gathering, preparing, and submitting the complete provisional application to the PTO. Time will vary depending upon
`the individual case Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden,
`should be sent to the Chief lnfomiation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, Washington, DC
`20231. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Box Provisional Application, Assistant
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`
`NU MARK Ex.1007 p.1
`
`

`

`RESPIRATORY MONITORING SYSTEMS AND METHODS
`
`PATENT
`Attorney Docket No.: 82021-0033
`
`FIELD OF THE INVENTION
`
`The present invention relates, in general, to respiratory monitoring and, more
`
`5
`
`particularly, to respiratory monitoring associated with medical devices.
`
`BACKGROUND OF THE INVENTION
`
`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
`
`l 0
`
`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
`
`15
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`evidenced by continuing reports of negative patient episodes due to inadequate, improper or
`
`inaccurate respiratory monitoring.
`
`Capnometry systems have been used with some success in assessing the respiration of a
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`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
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`20
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`consumption via the respiratory quotient, which usually has a value of 0. 8. Mainstream
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`capnometers consist of a small infrared gas analysis bench that is mounted directly in the
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`patient's respiratory path providing real-time information regarding the C02 level in the
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`patient's respiration. However, the sampling cell used by mainstream capnometers 1s, m
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`general, relatively bulky and heavy. The sample cell of a mainstream capnometer can be in the
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`25
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`way when mounted in the respiratory path, e.g., in front of a patient's face. Sidestream
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`capnometers have a pump that contmuously aspirates gas samples from the patient's
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`respiratory path, typically at a sampling flow rate of about 200 ml/min, via a sampling tube that
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`carries the sample gas to a gas analysis bench. The finite transport time from the sampling site
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`to the gas analysis bench introduces an undesirable time lag. When a patient stops breathing,
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`30
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`the measured and displayed C02 level becomes a flat line at zero mm Hg because there are no
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`exhalations containing C02. Further, a patient's inhalation generally draws room air (0.003%
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`C02) or gas having zero or negligible carbon dioxide concentration such that the inspired C02
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`\\\DC - 8202110033 - 1641270 vl
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`NU MARK Ex.1007 p.2
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`

`

`PATENT
`Attorney Docket No.: 82021-0033
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`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 respiratory status and phase of respiration.
`
`5
`
`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 uncomfortable and anxiety inspiring. In
`
`addition, many procedures require oral access (e.g., esophogastroduodenoscopy and oral
`
`10
`
`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 respiratory data of sufficient
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`clinical accuracy. The need has therefore arisen for a respiratory monitor that functions
`
`15
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`independently of a sealed face mask and monitors respiration with sufficient clinical accuracy.
`
`Existing respiratory monitors are generally integrated with alarm systems, where a
`
`clinician is alerted to the presence of respiratory compromise by visual and/or audio alarms. In
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`an operating or procedure room environment, where there are multiple alarm sources and
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`auditory and visual stimuli, it may take a while before the attending clinician is able to
`
`20
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`determine the cause of the alarm and take appropriate action to remedy the situation. In
`
`critical circumstances, 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 automatically taking steps to gather additional
`
`information and placing other aspects of a drug delivery system into a safe state.
`
`25
`
`Existing alarm algorithms or mechanisms generally alert the attending clinician in the
`
`event of an alarm condition. In the event of malfunction of the alarm mechanism itself, e.g.,
`
`failure of the buzzer for an audible alarm or the LED 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
`
`30
`
`the critical patient condition and take timely corrective action. The need has therefore arisen
`
`for an alarm and monitoring system that provides real-time monitoring of respiration
`
`throughout the duration of a procedure, where a clinician may still be able to readily ascertain
`
`11\0C - 8202110033 - 1641270 vi
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`2
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`NU MARK Ex.1007 p.3
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`

`PATENT
`Attorney Docket No.: 82021-0033
`
`whether respiration has been compromised, even in the absence or failure of an alarm
`
`mechanism
`
`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
`
`5
`
`clinician ofthis 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 pre-determined time
`
`window. By taking shallow but frequent 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
`
`l 0
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`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
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`anthropomorphic alarm paradigm is generally less rigid and more context sensitive because it
`
`15
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`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
`
`resplfatory rate and estimated tidal volume.
`
`SUMMARY OF THE INVENTION
`
`20
`
`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 additional 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
`
`25
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`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
`
`minimize distracting alarms and time and motion expenditure. The present invention further
`
`30
`
`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.
`
`\\\DC- 8202110033 · 1641270 vl
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`3
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`NU MARK Ex.1007 p.4
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`

`

`PATENT
`Attorney Docket No.: 82021-0033
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`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;
`
`5
`
`FIG. 2 illustrates a block diagram of a more detailed view of one embodiment of a
`
`respiratoty monitoring system in accordance with the present invention;
`
`FIG. 3 illustrates one embodiment of a nasal interface in accordance with the present
`
`invention;
`
`FIG. 4 illustrates one embodiment of an ear mount in accordance with the present
`
`10
`
`invention;
`
`FIG. 5 illustrates one embodiment of a support band in accordance with the present
`
`invention;
`
`FIG. 6 illustrates one embodiment of a method for pressure waveform analysis and
`
`segmentation depicting positive pressure thresholds and negative pressure thresholds in
`
`15
`
`accordance with the present invention;
`
`FIG. 7 illustrates one embodiment of an LED display in accordance with the present
`
`invention;
`
`FIG. 8 illustrates one embodiment of a method for employing a respiratory monitoring
`
`system in accordance with the present invention; and
`
`20
`
`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
`
`FIG. 1 illustrates a block diagram depicting one embodiment of the present invention
`
`25
`
`comprising a sedation and analgesia system 22 having user interface 12, software controller 14,
`
`peripherals 15, power supply 16, external communications 10, respiratoty monitoring 11, 02
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`delivety 9 with manual bypass 20 and scavenger 21, patient interface 17, and drug delivety 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
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`30
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`disclosed and enabled by U.S. Patent Application Serial No. 09/324,759, filed June 3, 1999 and
`
`incorporated herein by reference in its entirety. It is further contemplated that respiratoty
`
`monitoring 11 be used in cooperation with sedation and analgesia systems, anesthesia systems
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`11\DC - 8202110033 - 1611270 vl
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`4
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`NU MARK Ex.1007 p.5
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`

`PATENT
`Attorney Docket No.: 82021-0033
`
`and integrated patient monitoring systems, independently, or in other suitable capacities.
`
`Embodiments of patient interface 17 are disclosed and enabled by U.S. Patent Application
`
`Serial No. 09/592,943, filed June 12, 2001 and U.S. Patent Application Serial No. 09/878,922
`
`filed June 13, 2001 which is incorporated herein by reference in its entirety.
`
`5
`
`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 interface 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
`
`10
`
`inhalation and exhalation. Visual display 31 may be a series oflight 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.
`
`15
`
`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
`
`20
`
`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.
`
`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 caused by
`
`25
`
`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 finite numerical signals before
`
`30
`
`the finite numerical signals are transmitted to controller 14 via connection 36. Controller 14
`
`may convert the finite numerical signals to digital signals, where the digital signals are routed
`
`from controller 14 to ADIO device 29 via connection 37. Digital signals relating to patient
`
`\\\IX> 82021/0033- 1641270 vi
`
`5
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`NU MARK Ex.1007 p.6
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`

`

`PATENT
`Attorney Docket No.: 82021-0033
`
`respiration 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
`
`5
`
`combinations or permutations on a single integrated circuit.
`
`In one embodiment of the present invention, controller 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
`
`10
`
`episode, or reactivate drug delivery upon receipt of data indicating that patient 18 is no longer
`
`experiencing a potentially life-threatening event.
`
`FIG. 3 illustrates one embodiment of nasal interface 40 associated with cannula 30
`
`(FIG. 3). In one embodiment 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
`
`15
`
`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.
`
`20
`
`Embodiments of the present invention may comprise 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 comprises a plurality of oxygen delivery ports, where oxygen may be
`
`25
`
`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 co2 concentration or
`
`partial pressure via nasal interface 40.
`
`30
`
`Still referring to FIG. 3, nasal interface 40 may be constructed from nylon, acrylonitrile
`
`butadiene styrene (ABS), acrylic, poly-carbonate, or any other suitable material for use in
`
`medical devices. It is further consistent with the present invention to monitor C02, respiratory
`
`\\\DC· 8202110033. 1641270 vi
`
`6
`
`NU MARK Ex.1007 p.7
`
`

`

`PATENT
`Attorney Docket No.: 82021-0033
`
`~l' 'u
`,;12
`
`' '
`
`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
`
`5
`
`other suitable peripherals. The tubing may be constructed out of nylon, polyvinyl, silicon, or
`
`other suitable materials commonly known in the art.
`
`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
`
`10
`
`surface 53, and second interfacing 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
`
`15
`
`interfaces with LED display 60 (described below with respect to FIG. 7).
`
`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
`
`20
`
`from ABS, polycarbonate, or any other suitable material commonly known in the art.
`
`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
`
`25
`
`59 may be constructed from any suitable material conunonly 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
`
`30
`
`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
`
`\\\DC - 8202110033-1641270 vi
`
`7
`
`NU MARK Ex.1007 p.8
`
`

`

`PATENT
`Attorney Docket No.: 82021-0033
`
`visible to the naked eye simultaneously. 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
`
`5
`
`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 may be integrated with a bracelet, an adhesive for attachment to existing
`
`medical structures, or placed in a remote location for remote monitoring. One embodiment of
`
`10
`
`LED display 60 is further disclosed in FIG. 7.
`
`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 mas 78. FIG. 6
`
`illustrates one full tidal breath of patient 18, where positive pressure region 76 correlates with
`
`15
`
`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.
`
`The present invention comprises establishing a series of predetermined positive pressure
`
`20
`
`thresholds 79, 80, 81, 82, 83, 84 and a series of predetermined negative pressure thresholds 85,
`86, 87, 88, 89, 9o. 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
`
`25
`
`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 respiratory condition of patient 18 in a semi(cid:173)
`
`quantitative manner. Any suitable number of predetermined thresholds 79, 80, 81, 82, 83, 84,
`
`30
`
`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,
`
`\\\DC· 8202110033 - IMl270 vi
`
`8
`
`NU MARK Ex.1007 p.9
`
`

`

`PATENT
`Attorney Docket No.: 82021-0033
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`62, 63, 64, 65, 66 are of a particular color such as, for example, blue or gray. The present
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`invention further comprises associating negative pressure thresholds 85, 86, 87, 88, 89, 90
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`where LEDs 68, 69, 70, 71, 72, 73 are of a particular color different from that associated with
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`exhalation LEDs 67 such as, for example, green. Providing variable color for patient 18
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`inhalation and exhalation allows user 13 to ascertain at a glance whether patient 18 is inhaling
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`or exhaling, and the pressure magnitude associated with the exhalation or inhalation.
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`The present invention further comprises establishing alarm parameters within controller
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`14, where if the inhalations or exhalations of patient 18 do not exceed predetermined pressure
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`thresholds for a predetermined period of time, controller 14 may initiate an alarm condition. In
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`the event of an alarm condition, controller 14 may be programmed to display evidence of the
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`alarm or potentially dangerous patient episode via a series of LEDs 90, 91, 92 associated with
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`LED display 60. For example, first series of LEDs 90 may correlate to a warning condition,
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`second series of LEDs 91 may correlate to a more significant warning condition, and third
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`series of LEDs 92 may correlate to yet a more significant warning condition.
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`FIG. 7 illustrates one embodiment of LED display 60 in accordance with the present
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`invention comprising first exhalation LED 61, second exhalation LED 62, third exhalation LED
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`63, fourth exhalation LED 64, fifth exhalation LED 65, and sixth exhalation LED 66,
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`collectively referred to as exhalation LEDs 67. LED display 60 further comprises first
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`inhalation LED 68, second inhalation LED 69, third inhalation LED 70, fourth inhalation LED
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`71, fifth inhalation LED 72, and sixth inhalation LED 73, collectively referred to as inhalation
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`LEDs 74. LED display 60 further comprises first series of LEDs 90, second series of LEDs
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`91, third series of LEDs 92, and base 93. In one embodiment of the present invention, base 93
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`is affixed to ear mount 54, where LEDs associated with LED display 60 face away from patient
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`18. However, it is contemplated that base 93 be constructed from flexible material or rigid
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`25 material where base 93 may be placed in any suitable highly visible location.
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`In one embodiment of the present invention, first exhalation LED 61 corresponds to
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`positive pressure threshold 79, where an exhalation that exceeds first positive pressure
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`threshold 79 will result in first exhalation LED 61 lighting. Second exhalation LED 62
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`corresponds to second positive pressure threshold 80, where an exhalation that exceeds second
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`positive pressure threshold 80 will result in both first exhalation and second exhalation LEDs
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`61, 62 lighting. LEDs corresponding to predetermined thresholds will additively light in the
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`above described fashion, where third exhalation LED 63 corresponds to third positive pressure
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`\\\DC - 8202110033 - 1641270 vi
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`NU MARK Ex.1007 p.10
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`PATENT
`Attorney Docket No.: 82021-0033
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`threshold 81, fourth exhalation LED 64 corresponds to fourth positive pressure threshold 82,
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`fifth exhalation LED 65 corresponds to fifth positive pressure threshold 83, and sixth
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`exhalation LED 66 corresponds to sixth positive pressure threshold 84.
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`The present invention further comprises providing inhalation LEDs 74 where first
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`inhalation LED 68 corresponds to negative pressure threshold 85, where an inhalation that
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`exceeds first negative pressure threshold 85 will result in first mhalation LED 68 hghtmg.
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`Second inhalation LED 69 corresponds to second negative pressure threshold 86, where an
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`inhalation that exceeds second negative pressure threshold 86 will result in both first inhalation
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`and second inhalation LEDs 68, 69 lighting. LEDs corresponding to predetermined thresholds
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`l 0 will additively light in the above described fashion, where third inhalation LED 70 corresponds
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`to third negative pressure threshold 87, fourth inhalation LED 71 corresponds to fourth
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`negative pressure threshold 88, fifth inhalation LED 72 corresponds to fifth negative pressure
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`threshold 89, and sixth inhalation LED 73 corresponds to sixth negative pressure threshold 90.
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`The thresholds 79 - 90 may be absolute or relative values. For example, for a pressure
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`sensor where 0 output voltage represents zero or ambient pressure, each threshold may be
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`fixed at a set voltage representing a given pressure level. With a bi-polar, linear pressure
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`sensor where each inch of water pressure is l 0 volts of output voltage and 0 V represents
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`ambient (zero) pressure, a first threshold may be set at +O. 1 V representing a pressure
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`threshold of0.01'' of water. However if the zero output voltage drifts on the pressure sensor
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`("zero drift"), the absolute voltage thresholds will no longer correspond to the desired pressure
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`thresholds. Thus, a preferred embodiment uses relative pressure thresholds whereby the llllique
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`voltage corresponding to each threshold is re-adjusted to maintain the desired difference
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`relative to the new output voltage at ambient pressure, in the event of zero drift. This method
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`requires frequent zero calibration of the pressure sensor by exposing it intermittently and
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`briefly to ambient pressure and recording the actual output voltage at zero or ambient pressure.
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`LED display 60 further comprises first series of LEDs 90, where first series of LEDs 90
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`may be associated with a first alarm condition, second series of LEDs 91, where second series
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`of LEDs 91 may be associated with a second alarm condition, and third series of LEDs 92,
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`where third series of LEDs 92 may be associated with a third alarm condition. First, second,
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`and third series of LEDs 90, 91, 92 may employ any suitable number of LEDs such as, for
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`example, four LEDs in each series, where the LEDs may be of any suitable color and may be
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`programmed to blink, revolve, or indica