`
`(12) United States Patent
`Peters et al.
`
`(10) Patent No.:
`
`(45) Date of Patent:
`
`US 7,114,510 B2
`Oct. 3, 2006
`
`(54)
`
`(75)
`
`(73)
`
`VALVE WITH SMART HANDLE
`
`Inventors: Mark E. Peters, Hamilton, OH (US);
`Gregory W. Popp, Lebanon, OH (US)
`
`Assignees: INO Therapeutics, Inc., Clinton, N]
`(US); Ventek LLC, West Chester, OH
`(US)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 237 days.
`
`(21)
`
`Appl. No.:
`
`10/416,870
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4/1993 Knippscheer .......... .. 340/573.1
`5,202,666 A *
`4/1995 Wheeler et al.
`5,409,037 A
`8/1995 Thompson ................... .. 137/1
`5,441,070 A *
`10/1997 Lloyd et 211.
`5,680,329 A
`8/1999 Gorra .................... .. 340/573.1
`5,945,910 A *
`6,003,170 A * 12/1999 Humpert et al.
`............. .. 4/623
`6,236,317 B1*
`5/2001 Cohen et al.
`.......... .. 340/573.1
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`W0
`
`0961065
`W0 9836245
`
`12/1991
`8/1998
`
`(22)
`
`PCT Filed:
`
`Nov. 15, 2001
`
`* cited by examiner
`
`(86)
`
`(87)
`
`(65)
`
`(60)
`
`(51)
`
`(52)
`
`(58)
`
`PCT No.:
`
`PCT/US01/45519
`
`§ 371 (C)(1),
`(2), (4) Date:
`
`May 15, 2003
`
`PCT Pub. No.: W002/40914
`
`PCT Pub. Date: May 23, 2002
`
`Prior Publication Data
`
`US 2004/0045608 A1
`
`Mar. 11, 2004
`
`Related U.S. Application Data
`
`Provisional application No. 60/249,765, filed on Nov.
`17, 2000.
`
`Int. Cl.
`
`(2006.01)
`F16K 37/00
`U.S. Cl.
`................ .. 137/1; 137/552.7; 251/129.04;
`4/623
`
`Field of Classification Search ........... .. 137/552.7,
`137/1; 4/623; 251/129.04
`See application file for complete search history.
`
`Primary Examiner—A. Michael Chambers
`(74) Attorney, Agent, or Firm—Gibbons, Del Deo, Dolan,
`Griffinger and Vecchione
`
`(57)
`
`ABSTRACT
`
`A valve with a smart handle including a memory module to
`log relevant data. A sensor on the handle determines when
`the valve is open, and this triggers the start of timers and
`recording of the “open” event
`in a log in the memory
`module. When the valve is closed,
`the sensor triggers
`stopping of the timers and recording of the “closed” event in
`the log. The timer information is used to calculate the
`duration of the time “open” event, and this, together with the
`actual date and time of the opening and closing of the valve
`are recorded in the log. Other relevant information, such as
`cylinder fill date, cylinder 1.D. number, batch number, and
`patient name or account number may also be logged in the
`memory module. The log of the events and the correspond-
`ing dates and times may be used to prepare invoices for
`billing gas treatments, for inventory control, and for other
`record-keeping and control functions.
`
`18 Claims, 12 Drawing Sheets
`
`
`
`PRAXAIR 1004
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`001
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 1 of 12
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`US 7,114,510 B2
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`002
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`002
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 2 of 12
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`US 7,114,510 B2
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`003
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`003
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 3 of 12
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`US 7,114,510 B2
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`Sensor
`
`Open! Close
`
`O04
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`004
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 4 of 12
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`US 7,114,510 B2
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`.._._..___._W...w
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`005
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 5 of 12
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`US 7,114,510 B2
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`..x-.J...-.-§.$..
`_«.:I:.
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`12
`
`Fz‘é'-i
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`O06
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`006
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`
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 6 of 12
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`US 7,114,510 B2
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`007
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`007
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 7 of 12
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`US 7,114,510 B2
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`008
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 8 of 12
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`US 7,114,510 B2
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`009
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`009
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 9 of 12
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`US 7,114,510 B2
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`010
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`U.S. Patent
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`Oct. 3,2006
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`Sheet 10 of 12
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`US 7,114,510 B2
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`START ~
`
`LOG VALVE
`CLOSING EVENT
`
`
`cnms, nave,
`VALVE sums)
`
`
`Tn‘rruon‘Ta.) ‘TA
`
`CALCULATE
`ACCUMULATED
`OPEN TIME
`
`LOG VALVE
`OPENING EVENT
`
`(TIME. DATE.
`VALVE STATUS)
`
`LOG T,
`(ACCUM. nus;
`
`
`
`
`
`STORE T
`
`
`(T: = T
`(ADCUM LA D
`TIME VALUE
`
`$109.5 T, INTO
`NVROM
`
`
`
`LOG 7
`(OPEN 11355)
`
`s~ros=
`TIMER
`
`N
`
`I‘-'6:
`
`=7
`
`O11
`
`
`
`
`IS VALVE
`STILL OPEN?
`
`
`
`
`
`
`0
`
` Y
`
`nmeas
`cormnus TO
`RUN
`
`011
`
`
`
`U.S. Patent
`
`Oct. 3,2006
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`Sheet 11 of 12
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`US 7,114,510 B2
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`
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`F-.1910
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`F-‘éa
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`H O
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`12
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`012
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`
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`U.S. Patent
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`Oct. 3,2006
`
`Sheet 12 of 12
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`US 7,114,510 B2
`
`
`
`HA7MB - Palm Inxe, VII to 1-wire Hofi Adapter with iButton Site-
`
`97.251
`
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`O13
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`
`
`1
`VALVE WITH SMART HANDLE
`
`US 7,114,510 B2
`
`2
`
`This application is a National Stage Application of PCT/
`US01/45519 which claims priority from U.S. Provisional
`Application Ser. No.: 60/249,765 filed 17 Nov. 2000.
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to valves and, in particular,
`to a valve with a special handle that tracks the usage of the
`valve to enable logging and billing. The valve handle may
`thus be used not only to dispense a gas but, in combination
`with the disclosed procedure,
`to provide a method for
`conveniently providing tracking of the use of the gas and
`subsequent billing for medical treatments using the gas.
`Some medical treatments involve the use of gases that are
`inhaled by the patient. In the past, medical gas suppliers
`have charged for the gas in the cylinder at the time of
`delivering the filled cylinder to the user. This method has
`been used both for industrial and medical uses. Pharmaceu-
`
`tical gases, dispensed by prescription, have great variability
`of use from patient to patient due to treatment regimen and
`dispensing methods. A method of charging for treatment
`time would be a desirable way for allocating the true value
`of the product. However, in the past, there has not been a
`way to automatically track the duration of treatments by
`cylinder or to tie the treatments to the patients who receive
`the treatments in order to make it easy to bill for use of the
`gas. Such a method is provided in accordance with the
`present invention.
`
`SUMMARY OF THE INVENTION
`
`invention provides a valve with a smart
`The present
`handle for the gas bottle (or cylinder). This valve records all
`the treatment information and makes the information readily
`accessible for use in tracking and invoicing. It permits the
`vendor to invoice the user for total treatment time and to
`
`provide users, such as hospitals or clinics, the information to
`bill individual patients. It also provides both the vendor and
`the user with data which is useful for trend analysis and
`inventory control.
`The valve handle includes sensors for sensing the opening
`and closing of the valve, a timer for timing the duration over
`which the valve is opened, and an electronic memory device
`which records the pertinent information. The information
`recorded by the memory device may include the cylinder fill
`date, the lot batch number, cylinder number, the patient’s
`name, the number of times the valve is opened, and the date,
`time, and duration of each opening of the valve, as well as
`additional information, if desired.
`The data then can be readily transferred from the memory
`device to a device that generates reports or invoices.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is an exploded, perspective view of an example of
`a valve with a smart handle made in accordance with the
`
`present invention;
`FIG. 1A is the same view as FIG. 1 but from a different
`
`perspective and with the lock mechanism further exploded
`from the view;
`FIG. 2 is the same view as FIG. 1 but from a different
`
`perspective;
`FIG. 2A is the same view as FIG. 1 but with the lock
`
`mechanism further exploded from the view,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`FIG. 2B is a schematic diagram showing the processor
`mounted on the handle of FIG. 1 and the input/output
`devices associated with it;
`FIG. 3 is a side view of the valve of FIG. 1 mounted on
`
`a gas cylinder;
`FIG. 4 is an enlarged plan view of the valve and cylinder
`of FIG. 3;
`FIG. 5 is an exploded, perspective view of the handle part
`of the valve of FIG. 1;
`FIG. 6 is an enlarged bottom view of the assembled
`handle of FIG. 5;
`FIG. 7 is an enlarged side view of the assembled handle
`of FIG. 5;
`FIG. 8 is a section view taken along the line 8—8 of FIG.
`
`7;
`
`FIG. 9 is a schematic operational logic diagram for the
`valve handle of FIG. 1;
`FIG. 10 is a perspective view of the handle of the valve
`of FIG. 1;
`FIG. 11 is a perspective view of a hand-held recorder used
`to export data from the valve of FIG. 1;
`FIG. 12 is a perspective view of a button-type storage
`device used with the recorder of FIG. 11;
`FIG. 13 is a hand-held portable computer which may be
`used to initialize the memory device on the valve of FIG. 1,
`and which may be used to export data from the memory
`device;
`FIG. 14 is a wand reader used to transfer data to and from
`
`the valve handle of FIG. 1 and to and from a computer;
`FIG. 15 is a perspective view of a BlueDot receptor that
`may be used for transferring data from a button-type
`memory module (as shown in FIG. 12) to a computer; and
`FIG. 16 is an adapter which can be used to download data
`from the valve of FIG. 1 to a button-type memory module.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`FIGS. 1—16 show a first preferred embodiment of the
`present invention. A valve 10 is provided, which may be
`attached onto a gas cylinder 12. The cylinder may contain
`pharmaceutical gas or other gases.
`Referring to FIGS. 1, 2, and 3, the valve 10 includes a
`valve body 14, a stem 15 projecting upwardly from the valve
`body 14, and a handle 16 mounted on top of the valve stem
`15 for manually opening and closing the valve 10. FIGS. 1
`and 2 show that the valve body 14 includes a threaded inlet
`port 18 which screws onto the outlet port of the cylinder 12.
`The valve body 14 also includes an outlet port 20. The valve
`body 14, the outlet port 20, and the inlet port 18 may be
`modified for specific uses, cylinder sizes, or gases.
`The handle 16 mounts on the valve stem 15. An operator
`grasps the handle 16 and rotates it in order to open and close
`the flow of gas from the cylinder 12 to a ventilator or other
`gas dispensing device (not shown). The handle 16 has a
`substantially circular cross-section and includes ribs around
`its outer edge to facilitate grasping the handle.
`As shown in FIG. 2B, several electronic devices are
`mounted in the handle, including a processor 23, a timer 21,
`a reset button 27, an open/closed sensor 28, a battery 25, a
`display 26, and an electronic memory device 22. In this
`embodiment, the memory device 22 communicates with a
`one-wire port 22' that projects to the exterior of the handle
`16. The one-wire port 22' in this embodiment is a metal can,
`which has the same shape as the portable memory buttons
`22A, shown in FIG. 12, that can be used to transfer data from
`the handle’s memory 22 to other devices. This enables the
`
`014
`
`014
`
`
`
`US 7,114,510 B2
`
`3
`same communication devices to be used with the port 22'
`and with the memory buttons 22A.
`Most of the components of FIG. 2B are housed inside a
`compartment formed by the handle 16 and the cover 24 in
`this preferred embodiment. The processor 23 is located
`inside the handle cover 24 and communicates with the
`
`electronic memory device 22. Also inside the handle cover
`24 are two (2) small batteries 25. While FIG. 2B shows a
`single timer 21, there preferably are at least two timers 21,
`one of which is a calendar, and the other of which is an event
`timer. The reset button 27, located inside the handle 16, may
`be depressed to reset the event timer 21. At least a portion
`of the top surface of the handle cover 24 is clear, in order to
`permit the user to view the LCD display 26 mounted inside
`the handle 16. On the underside of the handle 16 is mounted
`the sensor 28, as seen in FIGS. 1A, 2 and 8. The sensor 28
`that is used in this preferred embodiment is a proximity
`switch model MK20-BV50:170 manufactured by Meder
`Inc. A collar 30 is mounted onto the valve body 14, just
`below the handle 16. This collar 30 holds a stationary
`magnet 32 (See FIG. 1). In the embodiment shown here, the
`collar 30 has a twenty-four-sided interior cross section 34
`which fits directly onto the nut 36 on the valve body 14, so
`the collar 30 remains stationary relative to the valve body as
`the handle 16 is rotated to rotate the valve stem 15, in order
`to open and close the valve. The angular position of the
`collar 30 may be changed by lifting it up and rotating it, then
`fitting it back down over the nut 36. However, this can be
`done only when the handle 16 is removed from the valve 10.
`The handle 16 is protected from undesired removal by a
`special stud 38 (such as a “Torx” stud) and its corresponding
`security nut 39 (See FIG. 5), making it difficult for anyone
`to tamper with the position of the collar 30 and magnet 32,
`as will be explained in detail later. The proximity sensor 28
`is mounted on the handle 16, and the collar 30 is positioned
`so that, when the handle 16 is rotated to the closed position,
`the sensor 28 is adjacent to the magnet 32 that is fixed to the
`collar 30. When the proximity sensor 28 is adjacent to the
`magnet 32, it sends no signal to the processor 23, thereby
`indicating that the valve is in the “closed” position. When
`the handle 16 is rotated to open the valve, the proximity
`sensor 28 senses that it has been moved away from the
`magnet and sends a signal to the processor 23, indicating an
`“open” position. The processor 23 instructs the memory 22
`to record the event of opening the valve and to record the
`time and date of the event as indicated by the calendar timer
`21. The processor 23 instructs the memory device 22 to
`continue checking the position of the valve as long as the
`valve 10 is open. When the valve is closed, the processor
`uses the logged open and close times to calculate the amount
`of time the valve was open and instructs the memory device
`22 to record that duration as well a recording an accumulated
`open time duration. Thus, every time the valve 10 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 10 is open is calculated and logged, and the accumu-
`lated open time is calculated and logged. FIG. 9 shows the
`operational logic for the timing and logging operation.
`While the simple proximity sensor 28 and magnet 32 are
`used in this preferred embodiment, many other arrange-
`ments are known in the art for sensing and signaling when
`the valve 10 is open and when it is closed, and it would be
`obvious to those skilled in the art to use other known sensing
`arrangements.
`The display 26 may be arranged to display in a variety of
`ways. However, in this embodiment, it alternates flashing of
`two different numbers—first the accumulated open time, and
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`
`then the open time for the current event preceded by a “plus
`sign”. If the valve is closed, then the current event open time
`flashes as a “minus sign” with no digits adjacent to the
`“minus sign”.
`The threaded security stud 38 is fixed at its top end to the
`handle cover 24 and projects downwardly. It is received by
`the special security nut 39, which is rotatable relative to the
`handle 16 but is trapped onto the underside of the handle 16.
`The nut 39 must be unthreaded from the stud 38 in order to
`remove the handle cover 24 to allow access to the interior of
`
`the handle 16. This arrangement helps make the handle 16
`tamper-proof. Once the handle cover 24 has been removed,
`there is access to the batteries 25, reset button 27, and so
`forth, and there is access to the screw 37 which secures the
`handle 16 to the valve stem 15.
`
`An optional locking device 54 (See FIGS. 1A and 2A)
`prevents inadvertent rotation of the handle 16 during trans-
`port and can only be installed when the valve handle 16 is
`in the closed position. This serves to provide additional
`visual cues of the valve handle 16 position to the user. The
`locking device 54 preferably is made of plastic and includes
`a curved wall 56, which conforms closely to the shape of the
`outside wall of the valve handle 16. An arm 58 extends
`
`inwardly from the lower end of the wall 56, and a finger 60
`projects upwardly from the free end of the arm 56. The
`finger 60 is designed to mate with the hole of the security nut
`39, while the arm 58 fits snugly within the notch 40 of the
`fixed collar 30. A tab 62 at the top end of the locking device
`56 projects both outwardly and inwardly, so that, when
`installed, the inward portion of the tab 62 snaps over the top
`of the handle 16 to retain the locking device 56 in place on
`the handle 16, with the finger 60 mated to the security nut
`39 and the arm 58 in the notch 40 of the collar 30.
`
`Since the collar 30 is fixed on the valve 14, and the arm
`58 of the locking device 54 is caught in the notch 40 of the
`collar 30, the locking device 54 is fixed and does not rotate
`relative to the valve body 14. Furthermore, since the finger
`60 is attached to the arm 58 (which is part of the locking
`device 54), and is mated to the security nut 39 (which is part
`of the handle 16), then the handle :16 is also unable to rotate
`relative to the valve body 14. In order to open the valve 10,
`the locking device 54 is removed by pushing downwardly on
`the outwardly-projecting portion of the tab 62 to release the
`inwardly-proj ecting portion of the tab 62 from the top of the
`handle 16, and then the locking device 54 is slid down-
`wardly to remove the finger 60 from the nut 39 and to
`remove the arm 58 from the notch 40. Then, the handle 16
`can be rotated to open the valve 10. As long as the locking
`device 54 is properly attached to the valve 10, accidental
`opening of the valve 10 (such as due to vibration during
`transport) is unlikely.
`Installation of the Valve and Handle:
`
`The following steps may be taken to install the valve and
`handle on the gas cylinder. First, the valve body 14 (without
`the valve handle 16) is installed onto the cylinder 12 by
`threading the inlet port 18 of the valve body onto the
`cylinder 12. At this point, the valve stem 15 is in the full
`clockwise (closed) position. The cover 24 is removed from
`the handle 16, and the handle 16 is temporarily placed onto
`the valve stem 15 by placing the square hole 15A of the
`handle 16 over the valve stem 15. The handle 16 should be
`
`in a position in which there will be easy access to the
`memory module 22. The location of the security nut 39
`should be noted, and then the handle 16 should be removed
`from the valve stem 15.
`
`015
`
`015
`
`
`
`US 7,114,510 B2
`
`5
`As shown in FIGS. 2 and 6, the collar 30 has a notch 40,
`which should only line up with the security nut 39 when the
`valve handle 16 is in the closed position, so the only time
`there will be access to the security nut 39 will be when the
`Valve is closed. This will ensure that the handle 16 may only
`be removed when the Valve 10 is closed. The target collar 30
`should be installed over the nut 36 with the notch 40 in the
`
`proper position to provide access to the security nut 39 when
`the valve is closed. The position of the notch 40 may be
`adjusted by lifting the collar 30 off of the nut 36, rotating the
`collar 30, and then reinstalling the collar 30 on the nut 36
`until the notch 40 on the collar 30 matches up with the
`intended location of the security nut 39. The 24-point
`cross-section 34 of the collar 30 allows for precise position-
`ing of the collar 30 on the hexagonal nut 36.
`Once the collar 30 and its notch 40 and magnet 32 are
`properly positioned onto the valve body 14, the handle 16
`can then be placed back onto the valve stem 15, with the
`square opening 15A of the handle 16 fitting onto the valve
`stem 15, making sure to align the security nut 39 with the
`notch 40 on the collar 30. The handle 16 is then secured to
`
`the stem 15 by using a Fender washer 35 and threading a
`button-head cap screw 37 from the top side of the handle 16
`into the threaded top of the stem 15, as is well known in the
`art. (See FIG. 1).
`The reset button 27 on the inside of the handle 16 is then
`
`depressed to reset the timers 21. The handle cover 24 is then
`installed onto the handle 16 by lining up the security stud 38
`with the security nut 39 and tightening the security nut 39
`from below, extending a tool upwardly through the notch 40.
`This draws the handle cover 24 onto the handle 16. The LCD
`
`display 26 should read -00.0 The minus sign indicates that
`the valve handle is not currently logging time and ensures
`that the magnet 32 on the target collar 30 and the sensor 28
`on the handle 16 are properly aligned. When the valve
`handle 16 is in the closed position, the LCD display 26
`toggles between a “ - - - ” display indicating that the valve
`10 is closed, to a “-XXX” display where XXX represents the
`total accumulated time the cylinder has been open. When the
`valve handle 16 is in the open position, the LCD display 26
`toggles between the treatment time display and the total
`accumulated time display.
`
`Configuring the Valve with Smart Handle
`Once the valve handle 16 is reset and is mounted on the
`
`cylinder 12, the valve handle should now be configured to
`input the initial parameters such as:
`Born on date (date when cylinder was filled)
`Cylinder serial number
`Gas lot number
`
`Set the timers (which may include a calendar timer and an
`event timer)
`Clear the log registers
`Additional area may be available for recording specific
`notes or information relative to a specific treatment or
`lot.
`
`This initial configuration would typically be done by the
`distributor who is filling and supplying the filled cylinders to
`the user. The distributor uses a computer in which the
`required software has been previously installed and the
`initialization parameters have been previously inputted. The
`distributor inputs the initialization parameters from its com-
`puter to the smart handle 16 by some known data transfer
`mechanism. In this preferred embodiment, the distributor
`uses the transfer device 44 shown in FIG. 14. This transfer
`
`device plugs into the distributor’s computer at one end, and
`the other end fits onto the one-wire port 22' on the handle 16
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`6
`to transfer the initialization parameter data from the dis-
`tributor’ s computer to the memory 22 in the valve handle 16.
`Similarly, the user (such as the hospital) may add more
`data into the memory device 22 of the valve 10. This
`information may include a patient identification number, a
`treatment number, and so forth, which the hospital may use
`for its record keeping and for billing its patients or other end
`users. One way to add that data is by using a hand held
`computer 50 or laptop (not shown), inputting the informa-
`tion into the computer 50 and transferring that information
`to the memory device 22 through an adapter 48 (shown in
`FIG. 16) and through the transfer device 44.
`The hospital or other user, as well as the distributor, may
`later download the data from the memory device 22 to be
`used for record keeping and billing.
`
`Valve Operation
`Typically, the outlet port 20 of the valve 10 is connected
`to a delivery device, such as a ventilator (not shown), which
`is used to adjust the concentration and flow rate or to mix
`gases administered to the patient. When the valve handle 16
`is turned to open or close the valve, the proximity sensor 28
`triggers the processor 23 to instruct the memory device 22
`to log the event, including date, time, and whether the event
`was an opening or a closing of the valve. This information
`is stored in a non-volatile, read-only-memory (NVROM) in
`the memory device 22. As was explained above, FIG. 9
`shows a schematic operational logic diagram for the timer of
`the valve 10. Thus, as the handle 16 is rotated to open the
`valve 10 in order to provide gas treatments to patients, the
`memory device 22 in the handle 16 records the number and
`duration of the treatments.
`
`All this information may be read or downloaded by the
`user and/or by the supplier, using a number of data transfer
`methods. Three methods are described here, but others may
`also be used.
`
`1—Using a PIR-2 reader (See FIG. 11), the information
`may be downloaded into portable DS-1996 iButtons 22A
`(See FIG. 12). Each portable iButton 22A has enough
`memory to store the data for 12 valves, with each valve
`having up to 72 logs.
`The data on the portable iButtons 22A may then be
`transferred to a computer via a DS-1402 BlueDot receptor
`52 (See FIG. 15). The data may be imported into a suitable
`software program, such as a spread sheet program,
`to
`generate usage reports or billing reports.
`2—The data may be downloaded directly onto a hand-
`held or lap-top computer 50 using a wand reader 44, as
`shown in FIG. 14, which communicates through the one-
`wire port 22', and then it may be downloaded from the
`portable computer 50 to a main computer. Depending upon
`the types of ports on the computer, an adapter 48, as shown
`in FIG. 16 may be used. Again, the data may be imported
`into a suitable software program to generate usage reports or
`billing reports.
`3—The data may be sent directly from the port 22' on the
`handle 16 to a printer.
`The user may use the generated reports to keep a record
`of the treatments on the patients, for record keeping, for
`billing the patients, and for checking the billing it receives
`from its supplier. The supplier may use the generated reports
`or print outs to bill the user for the treatments and for
`inventory control purposes.
`For instance, a worker may walk around the user’ s facility
`(a hospital or clinic, for example) at certain intervals with a
`reading device and download the data from the ports 22' on
`the handles 16 of the cylinders 12 to a portable iButton 22A
`
`016
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`016
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`US 7,114,510 B2
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`7
`or to some other portable recording device. It would also be
`possible for the handle 16 to include a transmitter to transmit
`the data to a remote recording device at intervals or on
`command, as desired. The HA7MB reader of FIG. 16
`(produced by Point Six, Inc. of 391 Codell Dr., Lexington,
`Ky. 40509, USA) may be used to transfer data from the
`memory device 22 to portable iButtons 22A using a hand-
`held computer 50. The collected data on the iButtons 22A is
`then downloaded into a main computer. The software in the
`computer then uses the data that has been collected to
`generate reports,
`to track treatments, do billings, and to
`control inventory. While this method of moving data from
`the valve handle 16 to the computer station is preferred, it is
`understood that many other methods for transmitting the
`data from the valve 10 to the main computer could be used.
`In the first preferred embodiment shown in FIGS. 1—16, a
`Dallas Semiconductor 1-wire protocol establishes a method
`for storing and retrieving information from the handle.
`Some advantages of this Smart Valve handle system
`include:
`
`The system provides a convenient way to track and charge
`for therapy, as the gas is being used, instead of just
`charging for a bottle of gas. This may be much more
`desirable for the parties.
`Actual treatment time can be ascertained directly at the
`gas cylinder, and the smart valve 10 is relatively tamper
`proof, so there is little opportunity for error or fraud.
`Little or no paperwork is required, as all the data is stored
`in electronic format.
`
`The data may be stored as a comma delimited file, making
`it easy to import the data into spreadsheet or database
`software (such as AccessTM or ExcelTM) for data ser-
`vicing and manipulation.
`Data logs are also maintained in the Smart Handle device
`allowing for a back-up of the downloaded material.
`The record of the Born On Date (date the cylinder is
`filled) and Batch number reside at the bottle in the
`memory device 22. It is not necessary to search this
`data in files from a serial number or bar code.
`
`The system allows for expansion and software develop-
`ment which will provide hospitals and researchers the
`ability to track trends in patient use of various treat-
`ments, develop therapy protocols, assign patient ID to
`cylinders,
`identify and control cylinders for blinded
`clinical
`trials, and other uses currently handled by
`means of complicated and labor-intensive administra-
`tive methods.
`
`Various password protections may be used to ensure that
`only the appropriate users can make certain inputs of
`data. For example, only the enterprise filling the cyl-
`inders should be able to input the Born On Date.
`The embodiment described above is only intended to be
`one example of a device 1nade in accordance with the
`present invention. It will be obvious to those skilled in the
`art that modifications may be made to the preferred embodi-
`ment described above without departing from the scope of
`the present invention.
`What is claimed is:
`
`1. A method for tracking the use of gas for medical
`treatments, said gas being confined in a suitable gas con-
`tainer having a valve thereon and a handle to open and close
`said valve manually, comprising the steps of:
`moving said handle to open said valve;
`sensing the opening of said valve;
`electronically recording onto a memory device as data the
`opening of the valve and the time the valve was opened;
`moving said handle to close said valve;
`
`5
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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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`8
`sensing the closing of said valve by a sensing means, and
`electronically recording onto a memory device as data
`the closing of the valve and the time the valve was
`closed;
`calculating from said times a duration of time that said
`valve was open and electronically recording that dura-
`tion as data, wherein the sensing means and the
`memory device are located in an assembly on the
`handle.
`
`2. A method for tracking the use of gas for medical
`treatments as recited in claim 1, and further comprising the
`step of inputting and recording onto the memory device
`patient identification information.
`3. A method for tracking the use of gas for medical
`treatments as recited in claim 2, and further comprising the
`steps of:
`importing said recorded usage data and patient identifi-
`cation information from said memory device into a
`computer; and
`using said imported patient identification information and
`usage data to create a billing invoice.
`4. A method for tracking the use of gas for medical
`treatments, comprising the steps of:
`mounting a valve on a gas container including a handle for
`opening and closing the valve manually;
`providing a sensor on said valve which senses when the
`valve is opened and closed;
`providing a timer on said valve including a calendar timer
`and an event timer;
`providing an electronic memory device on said valve in
`communication with said sensor and said timer;
`entering patient identification information into said elec-
`tronic memory device, said sensor, said timer and said
`electronic memory device being located in an assembly
`on said valve handle;
`creating electronic usage data based on the length of time
`the valve is open and storing that usage data in said
`electronic memory device;
`electronically communicating the associated patient infor-
`mation and usage data stored in the memory device to
`a remote computer; and
`using the associated patient information and usage data to
`generate an invoice.
`5. A valve handle assembly for mounting on a valve stem
`to open and close a valve, said assembly comprising:
`a valve handle body, defining a receptacle for receiving
`the valve stem;
`a sensor on said valve handle body, for sensing the
`opening and closing of the valve, said sensor including
`a proximity switch;
`a timer on said valve handle body, including a calendar
`timer and an event timer; and
`an electronic storage device mounted on said valve handle
`body,
`in communication with said sensor and said
`timer, wherein said storage device records the date and
`time of opening and closing of the valve and the
`duration of time that said valve is open.
`6. A valve handle assembly for mounting on a valve stem
`to open and close a valve as recited in claim 5, further
`comprising an electronic data input means in communica-
`tion with said storage device, for permitting a user to enter
`additional data to be stored with said date and time, and
`further comprising data output means for downloading data
`from said electronic storage device.
`7. A valve handle assembly as recited in claim 5, and
`further comprising a reset means on said assembly for
`resetting said timer.
`
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`9
`8. A valve handle assembly as recited in claim 7, wherein
`said handle assembly further comprises a cover enclosing
`said sensor, timer, memory and reset means and tamperproof
`means on said Valve handle assembly to prevent unautho-
`rized removal of said cover.
`
`9. A valve handle assembly as recited in claim 5, and
`further comprising a one-wire communication port project-
`ing to the exterior of said valve.
`10. A valve with a smart handle assembly, comprising:
`a valve body for controlling the dispensing of a fluid
`through said valve;
`a valve stem projecting from said valve body;
`a valve handle assembly mounted on said valve stem for
`opening and closing said valve, said valve assembly
`comprising:
`a sensor on said valve handle, which senses the opening
`and closing of said valve, said sensor including a
`proximity sw