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 I.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 corresponding dates and times may be used to prepare invoices for billing gas treatments, for inventory control, and for other record-keeping and control functions.

Description:
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. Pharmaceutical 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 
     The present invention provides a valve with a smart 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&#39;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, 
         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  22 A, shown in  FIG. 12 , that can be used to transfer data from the handle&#39;s memory  22  to other devices. This enables the same communication devices to be used with the port  22 ′ and with the memory buttons  22 A. 
     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 accumulated 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 arrangements 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 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 transport 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-projecting portion of the tab  62  from the top of the handle  16 , and then the locking device  54  is slid downwardly 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  15 A 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 . 
     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 positioning 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  15 A 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 computer 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&#39;s computer at one end, and the other end fits onto the one-wire port  22 ′ on the handle  16  to transfer the initialization parameter data from the distributor&#39;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 information 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  22 A (See  FIG. 12 ). Each portable iButton  22 A has enough memory to store the data for 12 valves, with each valve having up to 72 logs. 
     The data on the portable iButtons  22 A 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&#39;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  22 A 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  22 A using a handheld computer  50 . The collected data on the iButtons  22 A 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 Access™ or Excel™) for data servicing 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 development which will provide hospitals and researchers the ability to track trends in patient use of various treatments, 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 administrative 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 cylinders should be able to input the Born On Date.       

     The embodiment described above is only intended to be one example of a device made in accordance with the present invention. It will be obvious to those skilled in the art that modifications may be made to the preferred embodiment described above without departing from the scope of the present invention.