(12) United States Patent
`Bathe et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 8,573,209 B2
`*NoV. 5, 2013
`
`US008573209B2
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`
`
`................ .. 604/67
`1/1992 Sancoff et al.
`5,078,683 A *
`.
`604/67
`3/1992 Epstein et al.
`5,100,380 A *
`3/1993 Toth et al.
`.... ..
`340/626
`5,191,317 A *
`4/1996 Wolfet al.
`..
`.. 128/203.15
`5,505,195 A *
`9/1996 Bathe et al.
`.. 128/203.12
`5,558,083 A *
`2/1999 Dickerson, Jr.
`............. .. 137/557
`5,868,162 A *
`7/2000 Bathe et al.
`6,089,229 A
`8/2000 Bathe
`6,109,260 A
`10/2000 Bathe et al.
`6,125,846 A
`12/2000 Bathe et al.
`6,164,276 A
`12/2001 McDermott et al.
`6,326,896 B1 *
`6/2003 Bathe et al.
`6,581,592 B1
`7,114,510 B2 * 10/2006 Peters et al.
`7,298,280 B2 * 11/2007 Voege et al.
`
`........ .. 340/626
`
`.................... .. 137/1
`................ .. 340/606
`
`(54) GAS DELIVERY DEVICE AND SYSTEM
`
`(56)
`
`(75)
`
`Inventors: Duncan P. Bathe, Fitchburg, WI (US);
`John Klaus, Cottage Grove, WI (US);
`David Christensen, Cambridge, WI
`(US)
`
`(73) Assignee:
`
`INO Therapeutics LLC, Hampton, NJ
`(US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.:
`
`13/509,873
`
`(22)
`
`PCT Filed:
`
`Jan. 6, 2011
`
`(86) PCT No.:
`
`PCT/US2011/020319
`
`§ 371 (C)(1),
`(2), (4) Date:
`
`Jun. 11, 2012
`
`(87) PCTPub.No.: WO2012/094008
`
`PCT Pub. Date: Jul. 12, 2012
`
`(65)
`
`(51)
`
`(52)
`
`(58)
`
`Prior Publication Data
`
`US 2013/0000643 A1
`
`Jan. 3, 2013
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A62B 9/02
`F16K 31/02
`U.S. Cl.
`USPC ........... .. 128/205.24; 128/203.14; 128/204.21
`Field of Classification Search
`USPC ........................ .. 128/203.12, 203.14, 204.18,
`128/204.21—201.23, 205.24
`See application file for complete search history.
`
`(Continued)
`OTHER PUBLICATIONS
`
`“PCT International Search Report and Written Opinion for PCT/
`US2011/020319”,Jan. 31, 2012, 19 pages.
`
`(Continued)
`
`Primary Examiner — Justine Yu
`Assistant Examiner — Michael Tsai
`
`(74) Attorney, Agent, or Firm — Servilla Whitney LLC
`
`(57)
`
`ABSTRACT
`
`A gas delivery system including a gas delivery device (100),
`a control module (200) and a gas delivery mechanism is
`described. An exemplary gas delivery device includes a valve
`(107) assembly with a valve and circuit including a memory
`(134), a processor (122) and a transceiver (120) in commu-
`nication with the memory. The memory may include gas data
`such as gas identification, gas expiration and gas concentra-
`tion. The transceiver on the circuit of the valve assembly may
`send wireless optical line-of-sight signals to communicate the
`gas data to a control module. Exemplary gas delivery mecha-
`nisms include a ventilator (400) and a breathing circuit (410).
`Methods of administering gas are also described.
`
`7 Claims, 12 Drawing Sheets
`
`PRAXAIR 1001
`
`
`
`21341,
`
`_.
`l\/<>i/50
`
`. ‘
`
`J;.23,
`‘T:
`
`ozuveav
`MODULE
`
`001
`
`

`
`US 8,573,209 B2
`Page 2
`
`(56)
`
`References Cited
`
`Us. PATENT DOCUMENTS
`
`10/2009 Rock et al.
`2009/0266358 A1
`2/2011 Chen et al.
`2011/0041849 A1
`10/2011 Fine et a1.
`2011/0240019 A1
`2011/0284777 A1* 11/2011 Pitchford et al.
`
`............. .. 251/65
`
`7,849,854 B2 * 12/2010 DeVries et a1.
`........ .. 128/205.11
`
`.
`7,927,313 B2 *
`4/2011 Stewart et al.
`...... .. 604/189
`7,980,245 B2 *
`7/2011 Rice et a1.
`.............. .. 128/204.21
`8,291,904 B2
`10/2012 Bathe et 31.
`2002/0013551 A1*
`1/2002 Zaitsu et al.
`2002/0044059 A1
`4/2002 Reeder et al.
`2005/0172966 A1
`8/2005 Blaise et al.
`
`................ .. 604/151
`
`OTHER PUBLICATIONS
`.
`.
`.
`.
`.
`.
`.
`First Action Interview Pilot Program Pre-Interview Communication,
`dated Mar. 20, 2013, 6 pgs.
`
`* cited by examiner
`
`O02
`
`002
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 1 of 12
`
`US 8,573,209 B2
`
`
`
`SAMPLE SAS; G:§TiE‘s' PGRT
`
`288
`
`{}ELlVfiR‘f
`
`MODULE
`{IPU
`
`EMC)R\’
`
`
`L..ZZfiZ’ZZZ:i2ZZZZT,1ZZ
`
`
` 3.F
`'2
`‘x:
`.r«. .22.
`
`ELECEEENIE. =33: I I 3
`
`O03
`
`003
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 2 of 12
`
`US 8,573,209 B2
`
`004
`
`004
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 3 of 12
`
`US 8,573,209 B2
`
`150
`
`005
`
`005
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 4 of 12
`
`US 8,573,209 B2
`
`FIG.
`
`4
`
`134
`
`125
`
`128
`
`150
`
`OPEN/CLOSE
`SENSOR
`
`VALVE
`PROCESSOR
`
`\
`
`120
`
`VALVE
`TRANSCEIVER
`
`VALVE
`DISPLAY
`
`
`
`O06
`
`006
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 5 of 12
`
`US 8,573,209 B2
`
`FIG. 6
`
`LINK IS INVALID
`
`TRANSHIT ATTENTION
`SIGNAL AT 10mS
`INTERVAL
`
`VALID
`RESPONSE?
`
`LIM( IS INVALID
`
`LINK IS VALID
`
`LINK MAINTENANCE —
`ONE SECOND INOmeter
`SYNCHRONDUS MESSAGE
`EXCVMNGE
`
`SYNCHRDNIZATION.
`
`LINK CPU
`INTERVAL
`INCREASED
`
`LINK CPU
`INTERVAL
`DECREASED
`
`007
`
`007
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 6 of 12
`
`US 8,573,209 B2
`
`008
`
`008
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 7 of 12
`
`US 8,573,209 B2
`
`009
`
`009
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 8 of 12
`
`US 8,573,209 B2
`
`010
`
`010
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 9 of 12
`
`US 8,573,209 B2
`
`011
`
`011
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 10 of 12
`
`US 8,573,209 B2
`
`012
`
`012
`
`

`
`U.S. Patent
`
`Nov. 5, 2013
`
`Sheet 11 of 12
`
`US 8,573,209 B2
`
`FIG. 12
`
`
`
`I-----__—--_———---——_--I
`
`CYLINDER NOT
`RECOGNIZED
`(DISPLAY ICON
`NOT PRESENT)
`
`
`
`
`
`
`READ CYLINDER
`CONCENTRATION 8
`EXPIRATION
`
`
`
`
`
`
`
`RECOGNIZED
`(NORYAL CYLINJER
`ICON ON DISPLAY)
`
`
`
`RECOGNIZED
`(FLASHING CYLINDER
`ICON ON DISPLAY!
`
`O13
`
`013
`
`

`
`U.S. Patent
`
`NOV.5,2013
`
`Sheet120f12
`
`US 8,573,209 B2
`
`FIG.
`
`13
`
`780
`
`BOO
`
`ALARM
`EMITTED
`
`
`
` GAS DATA
`MATCH PATIENT
`INFORMATION?
`
`
`
`YES
`
`GAS AOHINSTERED
`TO PATIENT
`
`79°
`
`014
`
`FILL GAS SOURCE WITH GAS
`
`ATTACH VALVE ASSEMBLY TO
`GAS SOURCE TO ASSEMBLE
`GAS DELIVERY DEVICE
`
`72
`
`ENTER GAS DATA INTO MEMORY
`
`73|
`
`mmspom THE GAS DELIVERY
`DEVICE TO A FACILITY
`
`POSITION GAS DELIVERY
`DEVICE IN A CART WITH
`CONTROL MODULE
`
`ESTABLISH COMMUNICATION
`BETWEEN VALVE TRANSCEIVER
`AND CPU TRANSCEIVER
`
`COMMUNICATE GAS DATA TO
`CONTROL MODULE
`
`COMPARE GAS DATA TO PATIENT
`INFORMATION ENTERED INTO
`CPU MEMORY
`
`014
`
`

`
`1
`GAS DELIVERY DEVICE AND SYSTEM
`
`2
`module. The circuit of one or more embodiments includes a
`
`US 8,573,209 B2
`
`TECHNICAL FIELD
`
`Embodiments ofthe present invention relate to gas delivery
`device for use in a gas delivery system for administering
`therapy gas and methods of administering therapy gas.
`
`BACKGROUND
`
`Certain medical treatments include the use of gases that are
`inhaled by the patient. Gas delivery devices are often utilized
`by hospitals to deliver the necessary gas to patients in need. It
`is important when administering gas therapy to these patients
`to verify the correct type of gas and the correct concentration
`are being used. It is also important to verify dosage inforrna-
`tion and administration.
`
`Known gas delivery devices may include a computerized
`system for tracking patient information, including informa-
`tion regarding the type of gas therapy, concentration of gas to
`be administered and dosage information for a particular
`patient. However, these computerized systems often do not
`communicate with other components of gas delivery devices,
`for example, the valve that controls the flow of the gas to the
`computerized system and/or ventilator for administration to
`the patient. In addition, in known systems, the amount of gas
`utilized by a single patient is often difficult or impossible to
`discern, leading to possible overbilling for usage.
`There is a need for a gas delivery device that integrates a
`computerized system to ensure that patient information con-
`tained within the computerized system matches the gas that is
`to be delivered by the gas delivery device. There is also a need
`for such an integrated device that does not rely on repeated
`manual set-ups or connections and which can also track indi-
`vidual patient usage accurately and simply.
`
`SUMMARY
`
`Aspects of the present invention pertain to a gas delivery
`device that may be utilized with a gas delivery system and
`methods for administering therapy gas to a patient. One or
`more embodiments of the gas delivery devices described
`herein may include a valve and a circuit with a valve memory
`in communication with a valve processor and a valve trans-
`ceiver. One or more embodiments ofthe gas delivery systems
`described herein incorporate the gas delivery devices
`described herein with a control module including a central
`processing unit
`(CPU)
`in communication with a CPU
`memory and CPU transceiver. As will be described herein, the
`valve transceiver and the CPU transceiver may be in commu-
`nication such that information or data from the valve memory
`and the CPU memory may be communicated to one another.
`The information communicated between the valve memory
`and the CPU memory may be utilized for selecting a therapy
`for delivery to a patient and controlling delivery of the
`selected therapy to the patient. The gas delivery devices and
`systems described herein may be utilized with medical
`devices such as ventilators and the like to delivery gas to a
`patient.
`A first aspect of the present invention pertains to a gas
`delivery device. In one or more embodiments, the gas deliv-
`ery device administers therapy gas from a gas source under
`the control of a control module. In one variant, the gas deliv-
`ery device may include a valve attachable to the gas source
`and a circuit. The valve may include an inlet and an outlet in
`fluid communication and a valve actuator to open and close
`the valve to allow the gas to flow through the valve to a control
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`memory, a processor and a transceiver in communication with
`the memory to send wireless optical line-of-sight signals to
`communicate information stored or retained within the
`
`memory to the control module that controls gas delivery to a
`subject. In one or more alternative embodiments, the signals
`to communicate information stored or retained within the
`
`memory to the control module that controls gas delivery to a
`subject may be communicated via a wire. Examples of such
`wired signals may incorporate or utilize an optical cable,
`wired pair and/or coaxial cable. The circuit may include a
`memory to store gas data, which may include one or more of
`gas identification, gas expiration date and gas concentration.
`The transceiver may communicate to send the gas data to the
`control module via wireless optical line-of-sight signals.
`In one or more embodiments, the valve may include a data
`input in communication with said memory, to permit a user to
`enter the gas data into the memory. The gas data may be
`provided in a bar code that may be disposed on the gas source.
`In such embodiments, the gas data may be entered into the
`data input of the valve for storage in the memory by a user-
`operated scarming device in communication with the data
`input. Specifically, the user may scan the bar code to commu-
`nicate the gas data stored therein to the valve memory via the
`data input.
`In one or more embodiments, the valve may include a
`power source. In such embodiments, the power source may
`include a battery or other portable power source. In one or
`more embodiments, the valve transceiver may periodically
`send the wireless optical line-of-sight signals to the control
`module, wherein the signals are interrupted by a duration of
`time at which no signal is sent. In one or more specific
`embodiments, the duration of time at which no signal is sent
`comprises about 10 seconds.
`A second aspect of the present invention pertains to a gas
`delivery device, as described herein, and a control module in
`fluid communication with the outlet of the valve of the gas
`delivery device and with a gas delivery mechanism, such as a
`ventilator. In one or more embodiments, the control module
`may include a CPU transceiver to receive line-of-sight signals
`from the transceiver and a CPU in communication with the
`CPU transceiver. The CPU carries out the instructions of a
`
`computer program or algorithm. As used herein the phrase
`“wireless optical line-of-sight signal” includes infrared signal
`and other signals that require a transmitter and receiver or two
`transceivers to be in aligned such that the signal may be
`transmitted in a straight line. The CPU may include a CPU
`memory that stores the gas data that is communicated by the
`valve transceiver of the gas delivery device to the CPU trans-
`ceiver.
`
`In one or more embodiments, the gas delivery system may
`incorporate a valve with a timer including a calendar timer
`and an event timer for determining or marking the date and
`time that the valve is opened and closed and the duration of
`time the valve is opened. In such embodiments, the valve
`memory stores the date and time ofopening and closing ofthe
`valve and the duration of time that the valve is open and the
`valve transceiver communicates the date and time of opening
`and closing of the valve to the CPU transceiver for storage in
`the CPU memory.
`In one or more variants, the gas delivery system may incor-
`porate a control module that further includes an input means
`to enter patient information into the CPU memory. The con-
`trol module may also have a real time clock built into the CPU
`module such that the control module knows what the current
`
`time and date is and can compare that to the expiration date
`stored in the gas delivery device. If the expiration date is
`
`015
`
`015
`
`

`
`US 8,573,209 B2
`
`3
`passed the current date then the control module can cause an
`alarm and not deliver drug to the patient. When the term
`“patient information” is used, it is meant to include both
`patient information entered by the user and information that is
`set during manufacturing, such as the gas identification and
`the gas concentration that the control module is setup to
`deliver. The control module may also include a display. In one
`or more embodiments,
`the display incorporates an input
`means for entering patient information into the CPU memory.
`In one or more embodiments, the CPU of the control module
`compares the patient
`information entered into the CPU
`memory via the input means and the gas data from the trans-
`ceiver. The CPU or control module may include comprises an
`alarm that is triggered when the patient information entered
`into the CPU memory and the gas data from the transceiver do
`not match or conflict. As used herein the phrase “do not
`match,” includes the phrase “are not identical,” “are not sub-
`stantially identical,” “do conflict” and/or “do substantially
`conflict.” The CPU determines whether the patient informa-
`tion and additional data, or other data set matches by perform-
`ing a matching algorithm which includes criteria for estab-
`lishing whether one set of data (i.e. patient information) and
`another set of data match. The algorithm may be configured to
`determine a match where every parameter of the data sets
`match or selected parameters of the data sets match. The
`algorithm may be configured-to include a margin of error. For
`example, where the patient information require a gas concen-
`tration of 800 ppm, and the additional data includes a gas
`concentration of 805 ppm, the algorithm may be configured to
`include a margin of error of :5 ppm such it determines that the
`patient information and the additional data match. It will be
`understood that determining whether the patient information
`and additional data match will vary depending on the circum-
`stances, such as variables in measuring gas concentration due
`to temperature and pressure considerations.
`A third aspect of the present invention pertains to a control
`module memory comprising instructions that cause a control
`module processor to receive gas data from a valve via a
`wireless optical line-of-sight signal. The valve may be con-
`nected to a gas source and may include a memory for storing
`the gas data. The control module memory may include
`instructions that cause the control module processor to com-
`pare the gas data with user-inputted patient information. The
`user-inputted patient information may be stored within the
`control module memory. Gas data may be selected from one
`or more of gas identification, gas expiration date and gas
`concentration. In one or more embodiments, the control mod-
`ule memory may include instructions to cause the control
`module processor to coordinate delivery of therapy to the
`patient with a medical device, such as a ventilator and the like
`for delivering gas to a patient, via the wireless optical line-
`of-sight signal. The control module memory may also include
`instructions to cause the control module processor to select a
`therapy for delivery to a patient based on the received patient
`information and control delivery ofthe selected therapy to the
`patient.
`In one or more embodiments, the memory may include
`instructions to cause the processor to detect the presence of
`more than one valve and whether more than one valve is open
`at the same time. In accordance with one or more specific
`embodiments, the memory includes instructions to cause the
`processor to receive a first valve status selected from a first
`open position and a first closed position from a first valve via
`a first wireless optical line-of-sight signal with the first valve
`connected to a first gas source, receive a second valve status
`selected from a second open position and a second closed
`position from a second valve via a second wireless optical
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`
`line-of-sight signal with the second valve connected to a
`second gas source, compare the first valve status and the
`second valve status, and emit an alarm if the first valve status
`comprises the first open position and the second valve status
`comprises the second open position. In one or more altema-
`tive embodiments, the first valve status and the second valve
`status may be communicated to the processor via a single
`wireless optical line-of-sight signal, instead of separate wire-
`less optical line-of-sight signals. In a more specific embodi-
`ment, the memory of one or more embodiments may include
`instructions to cause the processor to terminate delivery of
`therapy if the first valve status comprises the first open posi-
`tion and the second valve status comprises the second open
`position.
`In one or more embodiments, the memory may include
`instructions to cause the processor to emit an alarm when a
`desired dose has been delivered through a valve. In such
`embodiments, the processor may include a memory to store
`the desired dose or dosage information. In such embodi-
`ments, the memory may include instructions to cause the
`processor to receive gas delivery information or information
`regarding the amount of gas delivered and compare the gas
`delivery information to the dosage information and emit an
`alarm when the gas delivery information and the do sage infor-
`mation match. As used herein, the term “do sage information”
`may be expressed in units of parts per million (ppm), milli-
`grams of the drug per kilograms of the patient (mg/kg), mil-
`limeters per breath, and other units known for measuring and
`administering a dose. In one or more embodiments, the dos-
`age information may include various dosage regimes which
`may include administering a standard or constant concentra-
`tion of gas to the patient, administering a gas using a pulsed
`method. Such pulsing methods includes a method of admin-
`istering a therapy gas to a patient during an inspiratory cycle
`of the patient, where the gas is administered over a single
`breath or over a plurality of breaths and is delivery indepen-
`dent of the respiratory pattern of the patient.
`A fourth aspect of the present invention pertains to a
`method for administering a therapy gas to a patient. In one or
`more embodiments, the method includes establishing com-
`munication between the patient and a gas delivery device via
`a transceiver, wherein the gas delivery device comprises a first
`memory including gas data, comparing the gas data with
`patient information stored within a second memory. The sec-
`ond memory may be included within a control module in
`communication with the gas delivery device. After comparing
`the gas data and the patient information, the method may
`further include coordinating delivery of therapy to a patient
`with the gas delivery device via a wireless optical line-of-
`sight signal, selecting a therapy for delivery to the patient
`based on the comparison of the gas data and the patient
`information and controlling delivery of the selected therapy
`to the patient. In one or more specific embodiments, the
`method may include entering the gas data into the first
`memory of the gas delivery device and/or entering the patient
`information into the second memory. In embodiments in
`which the method includes entering the patient information
`into the second memory, the control module may include
`input means by which patient information may be entered
`into the second memory. In one or more variants, the method
`includes ceasing delivery ofthe selected therapy to the patient
`based on the comparison of the gas data and the patient
`information. The method may include emitting an alert based
`on the comparison ofthe gas data and the patient information.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a diagram of a gas delivery system including a gas
`delivery device, a gas source, a control module and a gas
`delivery mechanism, according to one or more embodiments;
`
`O16
`
`016
`
`

`
`US 8,573,209 B2
`
`5
`FIG. 2 illustrates a valve assembly of the gas delivery
`device according to one or more embodiments attached to a
`gas source;
`FIG. 3 illustrates a disassembled View of the Valve assem-
`
`bly shown in FIG. 2;
`FIG. 4 is a diagram showing a circuit supported in the valve
`assembly shown in FIG. 2, according to one or more embodi-
`ments;
`FIG. 5 illustrates an exemplary gas source for use with the
`valve assembly shown in FIG. 2;
`FIG. 6 is an operational flow diagram of the communica-
`tion between the circuit of the gas delivery device shown in
`FIG. 1 with a control module regarding the establishment of
`communication between the circuit and the control module
`
`FIG. 7 illustrates a front view of an exemplary gas delivery
`system;
`FIG. 8 illustrates a back view of the gas delivery system
`shown in FIG. 7;
`FIG. 9 illustrates a partial side view of the gas delivery
`system shown in FIG. 7;
`FIG. 10 illustrates a front view of a control module accord-
`
`ing to one or more embodiments;
`FIG. 11 illustrates a back view ofthe control module shown
`in FIG. 10;
`FIG. 12 is an operational flow diagram of the communica-
`tion between the circuit of the gas delivery device and the
`control module shown in FIG. 1 regarding the gas contained
`within a gas source; and
`FIG. 13 is an operational flow diagram ofthe preparation of
`a gas delivery device and use within the gas delivery system
`according to one or more embodiments.
`
`DETAILED DESCRIPTION
`
`Before describing several exemplary embodiments of the
`invention,
`it is to be understood that the invention is not
`limited to the details of construction or process steps set forth
`in the following description. The invention is capable of other
`embodiments and of being practiced or being carried out in
`various ways.
`A system for the administration oftherapy gas is described.
`A first aspect of the present invention pertains to a gas deliv-
`ery device. The gas delivery device may include a valve
`assembly including at least one valve with a circuit. The gas
`delivery system may include the gas delivery device (e.g.
`valve assembly, including a valve and a circuit) in communi-
`cation with a control module to control the delivery of gas
`from a gas source to a ventilator or other device used to
`introduce the gas into the patient, for example, a nasal can-
`nula, endotracheal tube, face mask or the like. Gas source, as
`used herein, may include a gas source, gas tank or other
`pressured vessel used to store gases at above atmospheric
`pressure. The gas delivery system 10 is shown in FIG. 1. In
`FIG. 1, the valve assembly 100, including a valve 107 or valve
`actuator and a circuit 150, is in communication with a control
`module 200 via a wireless line-of-sight connection 300. In
`one or more alternative embodiments, communication
`between the valve assembly 100 and the control module 200
`may be established via a wired signal. The gas delivery sys-
`tem 10 also includes a gas source 50 including a gas attached
`to the valve assembly 100 and a gas delivery mechanism,
`which includes a ventilator 400 and a breathing circuit 410, in
`communication with the control module 200.
`
`FIGS. 2-4 illustrate the components of the valve assembly
`100. The valve assembly 100 includes a valve 107 and a
`circuit 150 supported in the valve assembly. FIG. 3 illustrates
`a disassembled view of the valve assembly 100, showing
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`10
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`15
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`20
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`25
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`30
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`35
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`40
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`45
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`50
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`55
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`60
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`65
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`6
`components of the physical circuit 150 and the valve 107. As
`shown in FIG. 4, which will be described in more detail
`below, the circuit 150 of the gas delivery device includes a
`valve transceiver 120 for establishing communication with
`the control module 200, which will also be discussed in
`greater detail below.
`Referring to FIG. 2, the valve 107 includes an attachment
`portion 102 for attaching the valve assembly 100 to the gas
`source 50, an inlet 104 and an outlet 106 in fluid communi-
`cation with the inlet 104, as more clearly shown in FIG. 2.
`FIG. 3 illustrates a disassembled view of the valve assem-
`
`bly 100 and illustrates an actuator 114 is disposed on the valve
`107 and is rotatable around the valve 107 for opening and
`closing the valve 107. The actuator 114 includes a cap 112
`mounted thereto. As shown in FIG. 3, the circuit 150 may
`include a data input 108 disposed on the actuator 114. The
`data input 108 may be disposed at other locations on the valve
`107. In one or more variants, the data input may include a port
`such as a USB port, a receiver for receiving electronic signals
`from a transmitted or other known input means known in the
`art for entering information or data into a memory.
`FIG. 4 illustrates a block diagram of the circuit 150. The
`circuit 150 shown in FIG. 4 includes a valve processor 122, a
`valve memory 134, a reset 128, a valve transceiver 120 and a
`power source 130. The circuit 150 may also include support
`circuits a timer 124, a sensor 126 and/or other sensors. Refer-
`ring to FIG. 3, the circuit 150 is supported within the valve
`assembly 100, with the physical components of the circuit
`150 specifically disposed between actuator 114 and the cap
`112. As shown in FIG. 3, the valve display 132 and the valve
`transceiver 120 are disposed adjacent to the cap 112, such that
`the valve display 132 is visible through a window 113. The
`sensor 126 and the valve processor 122 are disposed beneath
`the valve display 132 and the valve transceiver 120, within the
`actuator 114.
`
`The valve processor 122 may be one of any form of com-
`puter processor that can be used in an industrial setting for
`controlling various actions and sub-processors. The valve
`memory 134, or computer-readable medium, may be one or
`more of readily available memory such as electrically eras-
`able programmable read only memory (EEPROM), random
`access memory (RAM), read only memory (ROM), floppy
`disk, hard disk, or any other form of digital storage, local or
`remote, and is typically coupled to the valve processor 122.
`The support circuits may be coupled to the valve processor
`122 for supporting the circuit 150 in a conventional manner.
`These circuits include cache, power supplies, clock circuits,
`input/output circuitry, subsystems, and the like.
`In the embodiment shown, the valve memory 134 commu-
`nicates with a data input 108 disposed on the side of the
`actuator 114. The data input 108 shown in FIGS. 3-4 is used
`to transfer data from the valve memory 134 to other devices or
`to input data into the valve memory 134. For example, gas
`data, which includes information regarding the gas contained
`within the gas source, may be entered into the valve memory
`134 via the data input 108. In one or more alternative embodi-
`ments, the gas data may be programmed or directly entered
`into the valve memory 134 by the gas supplier. In one or more
`embodiments, the gas data may be provided in the form of a
`bar code 610 that is disposed on a label 600 that is afiixed on
`a to the side of the gas source, as shown in FIG. 5. The bar
`code 610 may be disposed directly on the gas source. An
`external scarming device in communication with the elec-
`tronic data input 108 may be provided and may be used to
`scan the bar code 61 0 and convey the information from the bar
`code 610 to the valve memory 134. Gas data may include
`information regarding the gas composition (e.g., NO, O2,
`
`017
`
`017
`
`

`
`US 8,573,209 B2
`
`7
`N02, CO, etc.), concentration, expiration date, batch and lot
`number, date of manufacturing and other information. Gas
`data may be configured to include one or more types of
`information. The Valve processor 122 may include instruc-
`tions to convey all or a pre-determined portion of the gas data
`via the Valve transceiver 120 to another transceiver.
`
`In embodiments that utilize a timer 124, the timer 124 may
`include two sub-timers, one of which is a calendar timer and
`the other of which is an event timer. The reset 128 may be
`located inside the actuator 114 and may be depressed to reset
`the event timer. The cap 112 also includes a window 113 that
`allows the user to see the valve display 132 disposed within
`the cap 112 that displays information regarding whether the
`actuator 114 is opened or closed and the duration the valve
`107 was opened or closed. In one or more embodiments, the
`valve display 132 may alternate flashing of two different
`numbers, a first number may be accumulated open time, and
`the second number may be the time at which the valve 107
`was opened for the current event. The time at which the valve
`107 was opened for a current event may be preceded by other
`indicators.
`
`The sensor 126 disposed within the actuator 114 may
`include a proximity switch model MK20-B-100-W manufac-
`tured by Meder Inc. The sensor 126 utilized in one or more
`embodiments may cooperate with a magnet (not shown) to
`sense whether the actuator 114 is turned on or turned off. Such
`sensors are described in U.S. Pat. No. 7,114,510, which is
`incorporated by reference in its entirety.
`For example, the sensor 126 and a corresponding magnet
`(not shown) may be disposed on a stationary portion of the
`valve 107. When the actuator 114 is rotated to the closed
`
`position, the sensor 126 is adjacent to the magnet that is in a
`fixed position on the valve 107. When the sensor 126 is
`adjacent to the magnet, it sends no signal to the valve proces-
`sor 122, thereby indicating that the actuator 114 is in the
`“closed” position or has a valve status that includes an open
`position or a closed position. When the actuator 114 is rotated
`to open the valve 107, the sensor 126 senses that it has been
`moved away from the magnet and sends a signal to the valve
`processor 122, indicating an “open” position. The valve pro-
`cessor 122 instructs the valve memory 134 to record the event
`ofopening the valve 1 07 and to record the time and date ofthe
`event as indicated by the calendar timer. The valve processor
`122 instructs the valve memory 134 to continue checking the
`position of the valve 107 as long as the valve 107 is open.
`When the valve 107 is closed, the valve processor 122 uses the
`logged open and close times to calculate the amount of time
`the valve 107 was open and instructs the valve memory 134 to
`record that duration and the accumulated open time duration.
`Thus, every time the valve 107 is opened, the time and date of
`the event is recorded, the closing time and date is recorded,
`the duration of time during which the valve 107 is open is
`calculated and recorded, and the accumulated open time is
`calculated and recorded.
`
`In one or more embodiments in which the power source
`130 includes a battery, the valve transceiver 120 may be
`configured to communicate with the CPU transceiver 220 to
`preserve the life of the battery. In this embodiment the valve
`transceiver 120 is only turned on to receive a signal from the
`Control Module CPU transceiver 220 for 20 msec every sec-
`ond. The control module CPU transceiver 220 sends out a
`
`short transmit signal continuously and ifthe valve transceiver
`120 is present it responds in the 20 msec interval. This con-
`serves battery power as the valve transceiver 120 is only
`powered on for 20 msec every second. When the valve trans-
`ceiver 120 responds it includes in its signal
`information
`regarding whether the communication from the control mod-
`
`8
`ule CPU transceiver 220 was early or late within this 20 msec
`window. This ensures that once communications has been
`
`established it is synchronized with the 20 msec window that
`the valve transceiver 120 is powered on and able to receive
`communications. For example, as shown in FIG. 6, the valve
`transceiver 120 sends a wireless optical line-of-sight