`Document Description: TrackOne Request
`
`PTO/SB/424 (12-11)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`T'tl
`
`f
`
`Duncan P. Bathe
`.
`.
`Gas Delivery Devnce And System
`
`Egtxfivnsnonal Application Number (If
`
`Unknown
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i), the prioritized examination fee set forth in 37
`CFR 1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) have been
`filed with the request. The basic filing fee, search fee, examination fee, and any required
`excess claims and application size fees are filed with the request or have been already been
`paid.
`
`The application contains or is amended to contain no more than four independent claims and
`no more than thirty total claims, and no multiple dependent claims.
`
`The applicable box is checked below:
`
`’ Ori
`
`inal A lication Track One - Prioritized Examination under
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the utility application via EFS-Web.
`___OR___
`
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed oath or declaration under 37 CFR 1.63 is filed with the application.
`
`Re uest for Continued Examination - Prioritized Examination under
`
`.
`
`'
`
`A request for continued examination has been filed with, or prior to, this form.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`No prior request for continued examination has been granted prioritized examination status
`under 37 CFR1.102(e)(2).
`
`66,947
`Practitioner
`)Rory P. AIenga
`Name
`Registration Number
`(Print/Typed
`Note: Signatures of all the inventors or assignees of record of the entire interest or their representative(s) are required in accordance with
`37 CFR 1.33 and 11.18. Please see 37 CFR 1.4(d) for the form of the signature.
`if necessary, submit multiple forms for more than one
`
`*Total of
`
`1
`
`forms are submitted.
`
`001
`
`PRAXAIR 1015
`
`sinature, see below".
`
`Sgnamre lRory P. Alegria, Reg. No. 66,947/
`
`6/11/12
`
`Date
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`001
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`
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`DOCKET # 3000—US—0026CON
`
`PATENT
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`GAS DELIVERY DEVICE AND SYSTEM
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`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This application is a continuation application of U.S. Patent Application Serial
`
`No.
`
`13/509,873
`
`filed on May
`
`15, 2012, which is
`
`the National Phase
`
`entry of
`
`PCT/US2011/020319, filed January 6, 2011,
`
`the entire content of which are incorporated
`
`herein by reference in their entirety.
`
`TECHNICAL FIELD
`
`[0002]
`
`Embodiments of the present invention relate to gas delivery device for use in a
`
`gas delivery system for administering therapy gas and methods of administering therapy gas.
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`10
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`BACKGROUND
`
`[0003]
`
`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
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`15
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`dosage information and administration.
`
`[0004]
`
`Known gas delivery devices may include a computerized system for tracking
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`patient information, including information regarding the type of gas therapy, concentration of
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`gas to be administered and dosage information for a particular patient. However,
`
`these
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`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 systenr
`
`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.
`
`[0005]
`
`There is a need for a gas delivery device that integrates a computerized systenr
`
`to ensure that patient information contained within the computerized system matches the gas
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`that is to be delivered by the gas delivery device. There is also a need for such an integrated
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`device that does not rely on repeated manual set-ups or connections and which can also track
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`20
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`25
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`individual patient usage accurately and simply.
`
`SUMMARY
`
`002
`
`002
`
`
`
`[0006]
`
`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. The
`
`therapy gas may comprise nitric oxide (NO). 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 transceiver. One or more embodiments of
`
`the gas delivery systems described herein incorporate the gas delivery devices described herein
`
`with a control module including a control 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 communication such that information or data from the valve memory and
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`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
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`delivery to a patient and controlling delivery of the selected therapy to the patient. The gas
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`delivery devices and systems described herein may be utilized with medical devices such as
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`ventilators and the like to delivery gas to a patient.
`
`[0007]
`
`A first aspect of the present invention pertains to a gas delivery device.
`
`In one
`
`or more embodiments, the gas delivery device administers therapy gas from a gas source
`
`containing NO under the control of a control module.
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`In one variant, the gas delivery device
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`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 module. The circuit of one or more embodiments
`
`includes a 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
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`signals.
`
`[0008]
`
`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.
`
`003
`
`003
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`
`
`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 scanning device in communication with the data input.
`
`Specifically, the user may scan the bar code to communicate the gas data stored therein to the
`
`valve memory via the data input.
`
`[0009]
`
`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.
`
`[0010]
`
`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
`
`transceiver.
`
`[0011]
`
`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 of opening and closing of the
`
`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.
`
`[0012]
`
`In one or more variants,
`
`the gas delivery system may incorporate a control
`
`module that further includes an input means to enter patient information into the CPU memory.
`
`The control module may also have a real time clock built into the CPU module such that the
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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
`
`004
`
`004
`
`
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`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 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 transceiver. 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 substantially identical,"
`
`"do conflict" and/or "do substantially conflict." The CPU determines whether the patient
`
`information and additional data, or other data set matches by performing a matching algorithm
`
`which includes criteria for establishing 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 concentration 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 i 5ppm 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 circumstances, such as variables in measuring gas concentration due to
`
`temperature and pressure considerations.
`
`[0013]
`
`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 connected to a gas source
`
`containing NO and may include a memory for storing the gas data. The control module
`
`memory may include instructions that cause the control module processor to compare 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
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`10
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`20
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`25
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`30
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`005
`
`005
`
`
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`10
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`15
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`identification, gas expiration date and gas concentration.
`
`In one or more embodiments, the
`
`control module 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
`
`of the selected therapy to the patient.
`
`[0014]
`
`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 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 alternative 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 wireless optical
`
`line—of—sight
`
`signals.
`
`In a more specific
`
`embodiment, 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
`
`position and the second valve status comprises the second open position.
`
`[0015]
`
`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 embodiments,
`
`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
`
`30
`
`alarm when the gas delivery information and the dosage information match. As used herein,
`
`the term "dosage information" may be expressed in units of parts per million (ppm), milligrams
`
`of the drug per kilograms of the patient (mg/kg), millimeters per breath, and other units known
`
`006
`
`006
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`
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`10
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`15
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`20
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`for measuring and administering a dose.
`
`In one or more embodiments, the dosage information
`
`may include various dosage regimes which may include administering a standard or constant
`
`concentration of gas to the patient, administering a gas using a pulsed method. Such pulsing
`
`methods includes a method of administering a therapy gas to a patient during an inspiratory
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`cycle of the patient, where the gas is administered over a single breath or over a plurality of
`
`breaths and is delivery independent of the respiratory pattern of the patient.
`
`[0016]
`
`A fourth aspect of the present invention pertains to a method for administering a
`
`therapy gas to a patient. The therapy gas may comprise NO. In one or more embodiments, the
`
`method includes establishing communication 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 second
`
`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 of the 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 of the gas data and the patient information.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0017]
`
`Figure l 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;
`
`[0018]
`
`Figure 2 illustrates a valve assembly of the gas delivery device according to one
`
`or more embodiments attached to a gas source;
`
`007
`
`007
`
`
`
`[0019]
`
`Figure 3 illustrates a disassembled view of the valve assembly shown in Figure
`
`2;
`
`[0020]
`
`Figure 4 is a diagram showing a circuit supported in the valve assembly shown
`
`in Figure 2, according to one or more embodiments;
`
`[0021]
`
`Figure 5 illustrates an exemplary gas source for use with the valve assembly
`
`shown in Figure 2;
`
`[0022]
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`Figure 6 is an operational flow diagram of the communication between the
`
`circuit of the gas delivery device shown in Figure l with a control module regarding the
`
`establishment of communication between the circuit and the control module
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`10
`
`[0023]
`
`[0024]
`
`[0025]
`
`Figure 7;
`
`Figure 7 illustrates a front View of an exemplary gas delivery system;
`
`Figure 8 illustrates a back view of the gas delivery system shown in Figure 7;
`
`Figure 9 illustrates a partial side view of the gas delivery system shown in
`
`[0026]
`
`Figure 10 illustrates a front view of a control module according to one or more
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`15
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`embodiments;
`
`[0027]
`
`[0028]
`
`Figure 11 illustrates a back view of the control module shown in Figure 10;
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`Figure 12 is an operational flow diagram of the communication between the
`
`circuit of the gas delivery device and the control module shown in Figure 1 regarding the gas
`
`contained within a gas source; and
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`20
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`[0029]
`
`Figure 13 is an operational flow diagram of the preparation of a gas delivery
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`device and use within the gas delivery system according to one or more embodiments.
`
`DETAILED DESCRIPTION
`
`[0030]
`
`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.
`
`[0031]
`
`A system for the administration of therapy gas is described. A first aspect of the
`
`present invention pertains to a gas delivery 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 (eg. valve assembly,
`
`including a valve and a circuit) in
`
`communication with a control module to control the delivery of gas from a gas source to a
`
`008
`
`008
`
`
`
`ventilator or other device used to introduce the gas into the patient, for example, a nasal
`
`cannula, 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 Figure 1.
`
`In Figure 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 system 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.
`
`[0032]
`
`Figures 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. Figure 3
`
`illustrates a disassembled view of the valve assembly 100, showing components of the physical
`
`circuit 150 and the valve 107. As shown in Figure 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.
`
`[0033]
`
`Referring to Figure 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
`
`communication with the inlet 104, as more clearly shown in Figure 2.
`
`[0034]
`
`Figure 3 illustrates a disassembled view of the valve assembly 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 Figure 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.
`
`[0035]
`
`Figure 4 illustrates a block diagram of the circuit 150. The circuit 150 shown in
`
`Figure 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
`
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`009
`
`009
`
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`10
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`sensor 126 and/or other sensors. Referring to Figure 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 Figure 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 1 I4.
`
`[0036]
`
`The valve processor 122 may be one of any fornr of computer 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 erasable 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.
`
`[0037]
`
`In the embodiment shown, the valve memory 134 communicates with a data
`
`input 108 disposed on the side of the actuator l 14. The data input 108 shown in Figures 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 embodiments, 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 affixed on a to the
`
`side of the gas source, as shown in Figure 5. The bar code 610 may be disposed directly on the
`
`gas source. An external scanning device in communication with the electronic data input 108
`
`may be provided and may be used to scan the bar code 610 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, 02, N02, CO, etc.), concentration, expiration date, batch and lot
`
`number, date of manufacturing and other information. Gas data may be configured to include
`
`30
`
`one or more types of information. The valve processor 122 may include instructions to convey
`
`all or a pre—deterrnined portion of the gas data via the valve transceiver 120 to another
`
`transceiver.
`
`010
`
`010
`
`
`
`10
`
`[0038]
`
`In embodiments that utilize a timer 124, the timer 124 may include two sub-
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`tirners, one of which is a calendar timer and the other of which is an event timer. The reset 128
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`may be located inside the actuator 114 and may be depressed to reset the event timer. The cap
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`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
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`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
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`accumulated open time, and the second number may be the time at which the valve 107 was
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`opened for the current event. The time at which the valve 107 was opened for a current event
`
`10
`
`may be preceded by other indicators.
`
`[0039]
`
`The sensor 126 disposed within the actuator 114 may include a proximity
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`switch model MK20-B-100-W manufactured 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 US. Patent No. 7,114,510, which
`
`is incorporated by reference in its entirety.
`
`[0040]
`
`For example, the sensor 126 and a corresponding magnet (not shown) may be
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`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
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`107. When the sensor 126 is adjacent to the magnet, it sends no signal to the valve processor
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`122, thereby indicating that the actuator 114 is in the "closed" position or has a valve status
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`that includes an open position or a closed position. When the actuator 114 is rotated to open the
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`valve 107, the sensor 126 senses that it has been moved away from the magnet and sends a
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`signal to the valve processor 122, indicating an "open" position. The valve processor 122
`
`instructs the valve memory 134 to record the event of opening the valve 107 and to record the
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`time and date of the event as indicated by the calendar timer. The valve processor 122
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`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
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`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.
`
`15
`
`20
`
`25
`
`30
`
`011
`
`011
`
`
`
`11
`
`[0041]
`
`In one or more embodiments in which the power source 130 includes a battery,
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`the valve transceiver 120 may be configured to communicate with the CPU transceiver 220 to
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`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 20msec every second.
`
`The control module CPU transceiver 220 sends out a short transmit signal continuously and if
`
`the valve transceiver 120 is present it responds in the 20msec interval. This conserves battery
`
`power as the valve transceiver 120 is only powered on for 20 msec every second. When the
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`valve transceiver 120 responds it includes in its signal information regarding whether the
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`communication from the control module CPU transceiver 220 was early or late within this
`
`10
`
`20msec window. This ensures
`
`that once communications has been established it
`
`is
`
`synchronized with the 20msec window that the valve transceiver 120 is powered on and able to
`
`receive communications. For example, as shown in Figure 6, the valve transceiver 120 sends a
`
`wireless optical line-of—sight signal during a pre-determined interval in response to a signal
`
`from the control module CPU transceiver 220. The wireless optical line-of—sight signals sent
`
`15
`
`by the valve transceiver 120 are a series of on off cycles where the transmitter is either
`
`transmitting light or is not and these correspond to digital binary signals. The mechanism by
`
`which the valve transceiver sends a wireless optical line-of—sight signal may be construed as a
`
`series of digital on off signals that correspond to data being transmitted. Once communications
`
`has been established between the control module CPU transceiver 220 and the valve
`
`transceiver 120, the interval between communication signals may be in the range from about
`
`20 seconds to about 5 seconds.
`
`In one or more specific embodiments, the interval or duration
`
`between transceiver signals may be about 10 seconds.
`
`[0042]
`
`As will be described in more detail below, the control module 200 includes a
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`CPU 210 which is connected to a CPU transceiver 220 which can send and receive wireless
`
`optical line-of—sight signals. The CPU transceiver 220 sends out a signal and waits for a
`
`response from the valve transceiver 120 when communication or more specifically, line-of-
`
`sight communication is established between the CPU transceiver 220 and the valve transceiver
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`120.
`
`If no response is sent by the valve transceiver 120, the CPU transceiver 220 sends
`
`another signal after a period of time. This configuration preserves battery life because the
`
`30
`
`valve transceiver 120 does not continuously send a signal unless requested to by the CPU 210.
`
`This is important as the gas delivery device and gas source spends most of its time in shipping
`
`and storage prior to being placed on the gas delivery system, if it was transmitting all this time
`
`012
`
`012
`
`
`
`trying to establish communications with the control module it would be consuming the battery
`
`life significantly.
`
`[0043]
`
`The valve processor 122 may include link maintenance instructions
`
`to
`
`determine whether the interva