GUI FOR INFUSION PUMPS

FIELD OF THE NVENTION

The present invention relates generally to the field of graphic user interfaces (GUI), more particularly to the field of medical pumps GUIs, especially infusion pumps or nutrition pumps.

BACKGROUND OF THE INVENTION

The field of GUI's has developed significantly through the last years, mainly since the consumers are more sophisticated than before. Further, many of the devices perform more of the same applications and features, that GUIs became one of the main distinguishing means in the field of electronic devices, and any device operated by the end-user. Thousands of patents discuss GUIs abilities, as US patent application 2005088409 discloses a method of providing a display for a GUI comprising the step of displaying a pointer on the display in a position corresponding to the position of a user's hand in a plane of a sensing region of a touch less input device is disclosed together with a computer program, a computer-readable storage medium and apparatus for the same. In particular, the method further comprises the step of displaying an indication on the display of the distance between the user's hand and either a reference point located in or adjacent the sensing region or a reference plane, parallel with the first plane and located through or adjacent the sensing region; or, alternatively, displaying an indication on the display of a suitable gesture of the user's hand for the purpose of manipulating the pointer.

The field of GUIs in medical devices is more complex than other electronic devices, mainly because of the great deal of responsibility and precision required from the device. For example, US patent 7,022,075 of Zonare Medical Systems, Inc discloses a GUI for an ultrasound system. The ultrasound system has operational modes and the GUI has corresponding icons, tabs, and page items image and information fields. It also provides several types of graphical elements with intelligent behavior, such as being context sensitive and adaptive, called active objects, for example, tabs, pages, icons, windows of user interaction and data display and an alphanumeric keyboard, provides for a touch screen for direct selection of displayed active objects and a limited set of hard and soft keys with

adaptive functionality that can be used with only one hand and potentially with only one thumb.

US patent No. 6,222,544 of Siemens Medical Systems, Inc., discloses a GUI for use in a patient treatment system that permits graphical display and editing of individual treatment parameters including machine positions and field shapes. Multiple fields grouped sequentially as an intensity modulated field (IMG) may be viewed as a superimposed graphical composite. In addition, a pictorial representation of the radiation beams incident on a particular target is provided. A graphic representation of field shape is provided; the graphics change as treatment progresses. Finally, manipulation of graphics permits editing of treatment information, while allowing immediate feedback as to the result of the change.

US patent 6,339,410 of Tellassist, Inc depicts an apparatus and method for communication between patients and caregivers who speak different languages, or with speech deficient persons. A touch sensitive screen is provided to allow a patient to select responses to questions posed by care givers. A simple GUI is provided which assists patients on respirators or otherwise unable to speak to communicate with hospital staff and family members. Combining thin profile LCD monitors with touch screen technology provides the user interface. The software features a large vocabulary of typical words and phrases which are grouped into sets which can be selected for display. Also, an image of the human body can be used to identify the location of pain. Word buttons can be replaced with pictures to assist children who cannot read. Additionally, words and phrases can be selected from by language pairs, such as English-English, English-Spanish, so that the common phrases assist in two way communication between patients and staff of differing languages.

Those patents show the increasing demand for GUIs in medical devices and the competition among firms to provide users with the most user-friendly and efficient devices which cause the minimal number of users' faults due to intelligent design, providing possible navigation options only and tools such as adaptive icons, soft keys, minimum user options and more. Such device in the field of infusion pumps is a long felt need.

SUMMARY OF THE INVENTION

It is a main object of the present invention to disclose a method of guiding a user in operating an infusion pump, comprising steps of (i) obtaining a graphic user interface for infusion pump (GUI-IP) implemented in an infusion pump's control unit (CU); (U) obtaining

an intuitively operable hierarchical array of operational pages; (Hi) interconnecting the same in a plurality of common infusion protocols; (iv) relating each of the pages to at least one stage of the infusion's protocol or to regulation of the same; (v) providing GUI-IP which comprises per each stage, one or more commands presenting only options that are possible in the stage; wherein degrees of freedom in operating said CUs are reduced and number of unnecessary faults decrease to minimum.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method further comprising step of providing a plurality of levels of authorization in inputting infusion parameters.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method is adapted to changing the levels of authorization, comprising the steps of requesting identification means from the user, inputting the identification means, analyzing the identification means, switching the level of authorization, inputting infusion parameters authorized only for high-level authority holders and returning to the former level of authorization.

Another object of the invention is to disclose the method as defined in any of the above, wherein the step of providing the level of authorization is further comprising steps selected from a group consisting of doctor authorizing, nurse authorizing, medic authorizing, patient authorizing, administrator authorizing, inclusive authorizing or system designer authorizing.

Another object of the invention is to disclose a method of providing infusion parameters details in an intuitive manner in an infusion pump control unit comprising step of obtaining unique icons and soft keys having intuitive interpretation.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method further comprising the step of changing their shape or location or size of said icons or soft keys.

Another object of the invention is to disclose a method of reducing the number of errors and faults in inputting parameters into an infusion pump control unit comprising step of obtaining minimum degrees of freedom by displaying the minimal data required and providing minimal options for the user

Another object of the invention is to disclose the method as defined in any of the above, wherein the method further comprising the step of displaying the inputted fields differently than other fields.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method further comprising the step of providing N buttons in addition to soft keys and thus avoiding accidental pressing on those buttons.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method further comprising the step of activating the buttons after a predetermined of time the buttons are pressed.

Another object of the invention is to disclose the method as defined in any of the above, wherein the method comprising adapting the GUI-IP for operating two or more different infusion protocols.

Another object of the invention is to disclose a method of facilitating navigation in an infusion pump control unit interface (IPCUI) comprising steps of providing minimal number of soft keys and adaptive icons; and displaying minimal number of navigating options using the icons and soft keys.

Another object of the invention is to disclose a method of inputting infusion parameters into an infusion pump control unit comprising step of inputting data according to medical competence and patient medical record.

Another object of the invention is to disclose a method as defined above, wherein the step of inputting infusion parameters is provided by step of inputting of parameters selected from a group consisting of number of dose, rate, volume, concentration, duration, medicine type or any combination thereof.

It is a main object of the present invention to disclose a graphic user interface for infusion pump (GUI-IP) implemented in an infusion pump's control unit (CU); said GUI-IP is adapted to operate two or more different infusion protocols, and comprising intuitively operable hierarchical array of operational pages interconnected in a plurality of common infusion protocols (sequence, pathways); each of said pages relates to at least one stage of said infusion's protocol or to regulation of the same; said GUI-IP comprising per each stage, one or more commands presenting only options that are possible in said stage; so as the

degrees of freedom in operating said CUs are reduced and number of unnecessary faults decrease to minimum.

The GUI-IP further comprising navigators, directing said user among said pages.

The GUI-IP further comprising displayers presenting predetermined infusion parameters being intuitively interpreted.

The GUI-IP further comprising a plurality of N buttons; each of said buttons executes a singular command at a specific stage, so as to minimize the number of faults. N is an integer number in the range from 2 to 6.

The buttons are activated by continuous push, so as it is operable only by a willful act. The buttons are selected from a group consists of ON/OFF, Start/Stop and dose/prime.

The GUI-IP further comprising at least one soft key configured to change infusion parameters and navigate among said interface pages. The soft keys are finger-operated.

The font of said pages is selected from a group consists of characters and numbers in Latin letters, Hebrew letters, Arabic letters, Latin, Cyrillic, and Korean Hangul, Hiragana, Kanji, Katanga, in any known fonts or combination thereof. The pages are displayed by two or more languages, selected by the user. The soft key includes user programmable function keys. The GUI-IP adapted to accept input using vocal commands. The soft key is configured to accept input via a touch screen.

The GUI-IP is adapted to several treatment performed by said infusion pump, especially intermittent, PCA, TPN, continuous treatments or any combination thereof.

The GUI-IP further comprising one or more icons, representing conditions, phases, stages, level of authority and infusion parameters.

The icons are selected from a group consists of sink representing the volume in the bag, syringe representing volume of dose or volume formerly infused.

The GUI-IP further comprising at least one mobile icon, especially adapted to represent whether the pump is on or off and/or the progress of the infusion and/or the progress of any other command.

The GUI-IP is especially adapted to securely input numbers and digits, especially adapted to input infusion parameters and users IDs, comprising at least one predetermined portion of the page (i.e., zone); each zone displays at least one digit.

The zone representing the inputted digit is different from other zones while the user inputs said digit, by parameters selected from a group including color, size, shape, vibration of the zone frame, changing the width of said frame, marking said frame or any combination thereof.

The digits are inputted separately, by increasing and/or decreasing the number by one or more units of measure.

The GUI-IP further comprising feedback mechanism, adapted to prevent faults that occur in case the user does not respond to a message or in case an inputted digit or number are out of normal range, or in case the user press a button longer than a predetermined period of time.

The mechanism includes feedback means, selected from a group including LEDs, vocal response, pop-ups, and vibration of the control unit, alerts, alerts to remote units, or any combination thereof.

The GUI-IP further comprising constantly displayed icons; said icons represent the level of authorization, whether the bubble detecting mechanism is either ON or OFF and whether the pump is in progress or not.

Messages are displayed upon inputting digits out of a predetermined range, providing the user with the possible range.

The user interface also enabling the user to change the display or location or size of at least a portion of the values displayed on one or more pages by marking appropriate fields or deleting the marking on said fields, especially in the view system page and any of the settings' or options' pages.

The user interface also enabling the user to add or remove content to or from said GUI, by transmitting one or more execute files to said CU using wired or wireless transmission.

The user interface also enabling said user to install or uninstall or update execute files or programs in said CU.

The content is selected from languages, digits, icons, biometric tests, personalized specifications concerning said infusion parameters or any combination thereof.

The messages are displayed upon user's mistakes or incorrect input of infusion parameters wherein said messages explain the user on the steps need to be taken such that the user's mission fulfilled. This helps the user with real-time knowledge concerning the next steps

thus the user avoids the need to read the manual with any problem or mistake as done in prior art GUIs.

BRIEF DESCRIPTION OF THE FIGURES

In order to understand the invention and to see how it may be implemented in practice, and by way of non-limiting example only, with reference to the accompanying drawing, in which

Figure 1 schematically presents the main page of the control unit when the pump is not running;

Figure 2 schematically presents the main page of the control unit when the pump is running; Figure 3 schematically presents the start and stop options of the control unit; Figure 4 schematically presents the PCA options when the pump is running; Figure 5 schematically presents log in options of the control unit, also adapted to change of authorization occasions; Figure 6 schematically presents the page displayed for a new treatment, this case the continuous treatment; Figure 7 schematically presents the page displayed for checking the range of the infusion parameters;

Figure 8 schematically presents the page displayed to view treatment values; Figure 9 schematically presents the page displayed to setup intermittent treatment; Figure 10 schematically presents the page displayed to show the system list for PCA mode; Figure 11 schematically presents the page displayed to show the options for the demand dose history;

Figure 12 schematically presents the page displayed to show the options for the alarm level; Figure 13 schematically presents the page displayed for faults and alarms; Figure 14 schematically presents the page displayed for errors; Figure 15 schematically presents the page displayed for faults, alarms and error messages; and, Figure 16 schematically presents the page displayed for faults, alarms and error messages.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide GUI for infusion pumps control units adapted to at least two infusion treatments.

The term 'graphic user interface (GUI)' refers in the present invention to means and methods of interacting with a computer or other electric or mechanic devices through a metaphor of direct manipulation or commands, the interface is assembled of many pages, each is connected to one or more pages of graphical images and widgets in addition to text. GUIs display visual elements such as icons, windows, arrows, digits, images and other gadgets.

The term 'infusion pump' refers in the present invention to infusion pump or perfuser or to feeding pumps which infuse fluids, medication or nutrients into a patient's circulatory system. Infusion pumps can administer fluids in ways that would be impractically expensive or unreliable if performed manually by nursing staff. For example, they can administer as little as 0.1 mL per hour injections (too small for a drip), injections every minute, injections with repeated boluses requested by the patient, up to maximum number per hour (e.g. in patient-controlled analgesia), or fluids whose volumes vary by the time of day.

The term 'GUI-IP' refers to GUIs especially adapted to infusion pumps as disclosed in the present invention.

The term 'touch screen' refers in the present invention to display overlay which is typically pressure-sensitive, electrically-sensitive, acoustically-sensitive, temperature-sensitive or photo-sensitive. The effect of such overlays allows a display to be used as an input device, removing the keyboard and/or the mouse as the primary input device for interacting with the display's content. Such displays can be attached to computers or, as terminals, to networks.

The term 'patient-controlled analgesia (PCA)' refers hereinafter to any method of allowing a person in pain to administer their own pain relief PCA has passed into medical jargon to mean the electronically controlled infusion pump that delivers a prescribed amount of intravenous or epidural analgesic to the patient when he or she activates a button.

The term 'total parenteral nutrition (TPN)' refers hereinafter to the practice of feeding a person without using the gut, i.e. intravenously. It is normally used following surgery, when feeding by mouth or using the gut is not possible, or when a person's digestive system cannot absorb nutrients due to chronic disease, or, alternatively, if a person's nutrient requirement cannot be met by internal feeding (tube feeding) and supplementation.

Intermittent infusion has a "high" infusion rate, alternating with a low programmable infusion rate to keep the cannula open. The timings are programmable. This mode is often used to administer antibiotics, or other drugs that can irritate a blood vessel.

Continuous infusion usually consists of small pulses of infusion, usually between 20 nano- liters and about 100 microliters, depending on the pump's design, with the rate of these pulses depending on the programmed infusion speed.

The term 'page' refers hereinafter to either page page or any display of text, digits, graphic presentation or combination thereof provided by an infusion pump. The page is optionally divided to multiple sections, each of which includes data. Some of those sections are possibly adapted for navigation among the pages.

The term 'command' refers hereinafter to input or operation command, e.g., performed by a control unit of an infusion pump or provided manually by a user. Common commands are Start/Stop, On/Off, Insert, Enter, Prime, Dose, Calibrate etc.

The term 'stage' refers hereinafter to either a state reached as a result of a command operation perform either manually or automatically. For example, stage refers to inputting infusion parameters, start of treatment, end of treatment, treating a patient, changing level of authorization, identification inputting or any act or phase written in the application.

The term 'icon' refers to a pictogram used in graphical user interfaces to represent a program, file, user, or other entity.

The term 'mobile icon' refers to an icon with special features. For example, an icon adapted to move, rotate, change its size, shape and place, or any of the like. An important mobile icon in this GUI has a constant size and shape, but the areas painted black and while changes constantly. Initially, there is only one clock-pointer like black line, but the line progresses and paints all the area it moves through in black.

The present invention discloses a GUI especially adapted to infusion pumps and to feeding pumps. The GUI is embedded in the control unit of the pump, facilitating the user to observe

and regulate infusion parameters in a safe manner. It also facilitates users to switch users and levels of authorization so as to prevent unforced errors. The GUI-TP provides interconnected pages, some provide data and others provide navigation or input options for the user. The user navigates among the pages using navigators, mainly adaptive and intuitive icons and soft keys, enabling the user to intuitively interpret the data displayed on the control unit. The GUI-IP enables the user to intuitively interpret infusion parameters by using adaptive displayers, such as clocks, specific zones on the page, where the data (parameters) is presented. The user uses touch screen in order to navigate and input those parameters, and is provided with buttons to command crucial commands, such as stop or start infusion, turn the pump on or off etc. in some embodiments of the control unit, the shape or size or texture of the buttons is different, such that the patient can intuitively press them without the need to read any letter written on or adjacent to the buttons. These buttons can be operated only after a continuous push, to prevent faults and errors. The user can switch the language or the font, since the GUI-IP supports multi-language and multi-font pages.

It is another aspect of the present invention to disclose a method of guiding a user in operating an infusion pump control unit. The method provides a plurality of levels of authorization in inputting infusion parameters. The method also provides the user with minimum degrees of freedom so as to reduce the number of unnecessary errors. For example, suggesting only the relevant options in any stage. The method enables user to control the infusion pump only by continuously pressing buttons, so as to prevent occasions where patients accidentally stop or start the infusion, or change the volume or rate of the infusion, or even turn off the infusion pump.

Reference is now made figure 1 schematically presents the Main page (11) of the control unit, displayed when the pump is not running, i.e., not infusing. The top section of the page displays the type of treatment performed by the pump, selected, inter alia, from Intermittent, PCA, TPN, and Continuous. On the right hand side of the second section, indication means regarding the battery power (13) are displayed. The next two sections show infusion parameters, such as number of dose, rate, volume, duration, medicine. The novel GUI provides the user with different icons for different parameters, and with icons adapted to different stages, such as alerts, stage when the user needs to feel the infusion with materials, or the like. This way the user obtains indication regarding the infusion status and is not forced to analyze infusion data provided by the control unit, and thus saves time. The bottom

section shows options regarding the next stage, either for regulating the parameters, navigate among pages in the GUI, or check for any system failures. According to this embodiment of the present invention, the alternatives are to switch to the Option Setup page, New Treatment page, or to the Program page. Figure 1 also shows the links and connections from the Option Setup, New Treatment, and Program pages to other pages. For example, the New Treatment page leads the patient to one of the treatment pages - Intermittent, PCA, TPN, and Continuous pages — first to the Default Value page, then to Set New Treatment page, and then to Setup page.

Reference is now made figure 2 schematically presents the main page of the control unit, displayed when the pump is running. The page is organized like the page in figure 1 , only this case the patient or other user can push the unlock button, preferably a touch screen button, in order to navigate to the Log in Function page, that leads the user to the Treatment Mode page, this case the Intermittent Mode page. As shown also in figure 1, from the Treatment Mode page, the user can go to all Mode Setup Function pages by pressing the PROG button. The user can also change the level of authorization by pressing the LOCK button.

Reference is now made figure 3 schematically presents the start and stop options of the control unit. While the pump infuses, the user can stop the infusion by pressing the Stop button. After pressing Stop button, the control unit presents another question, ensuring that the user wishes to stop the infusion. Unlike other pumps, there is no need to go to another page, since there are pop-ups used. Further, the start button is also adapted for stop commands, depends on the situation. Unlike soft keys, these buttons protrude from the lateral cross-section of the control unit, so as to differ Start, Stop, On, Off, Dose and Prime from other less crucial commands. According to one embodiment of the present invention, the control unit includes three buttons, each one used for two commands, preferably opposite commands, such as On and Off. The operation of the commands can be done after a long continuous push on the buttons, so as to avoid unintended crucial commands.

Reference is now made figure 4 schematically presents the PCA options when the pump is running. One of the main advantages of the present invention is its ability to provide services ad commands for a plurality of treatments, and navigate easily among the page pages of each treatment. Option pages comprise two soft keys displayed by two arrows, for navigating in the page, and easily and intuitively go from one line to another. Options pages exist for all four treatments, and include more than 4 options, which can be displayed

according to one embodiment. The user pushes the soft keys so as to reach the desired option; each option is added with an icon, preferably left to the option name, the icon preferably displays the level of authorization and the commands that can be done by the user. The user can choose an option also when not authorized, and input an ID number, so as to be authorized. After changing any parameter, the level of authorization is back to the level before the input of the ID.

Reference is now made figure 5 schematically presents Log in options of the control unit, also adapted to change the level of authorization. In order to change the level of authorization, the user needs to input a plurality of digits, preferably 2-6 digits, so that the system checks if the ID matches with a level of authorization. The digits are displayed in different zones, each distinguished during the input, by marking the zone frame, changing the zone shape, size, color, or any combination thereof. The input of digits is done by two soft keys, representing plus and minus. After changing the level of authorization, the system informs the user of the new action. In case the number is incorrect, the system also introduces the user with proper message.

Reference is made now figure 6 schematically presents the page displayed for a new treatment, this case the continuous treatment.

Reference is made now figure 7 schematically presents the page displayed for checking the range of the infusion parameters. Once the user inserted any number into the system, either number of doses, user ID, any volume or any other value, the system checks whether the inputted number or digit is in a suitable range. If not, a pop-up is used to display a message, preferably claiming that the number or digit is out of range. A soft key is used to guide the user back to the Inputting Number page, which is the only option. Suggesting one option only is initiative and decreases the number of errors.

Reference is made now figure 8 schematically presents the page displayed to View Treatment values. First, the system checks if the user actually wishes to view the details. If so, the values are displayed. At least one value is displayed on the page, preferably one line for each value. The values represent concentration, volume, and number of doses, duration, time, date, or any of the like. At least one number is provided for each value/parameter. For example, the first line shows data regarding dose. The word on the left is dose, the First number shows the dose's volume and the second number shows the number of doses taken during the former week.

Reference is made now figure 9 schematically presents the page displayed to the list of values relevant for each treatment. As mentioned above, the control unit is adapted to control at least two treatments, preferably selected from Intermittent, PCA, TPN and Continuous. Each of the treatments has a list of relevant values displayed during the treatment by the user's command. The display is simple and intuitive - the name of the parameter on the left, the value in the middle and the unit of measure on the right, according to one embodiment of the present invention.

Reference is made now figure 10 schematically presents the page displayed to show the system list for Intermittent mode. Once the user enters the Intermittent page, he has preferably six options. In this embodiment the options are dose, rate, KVO, reservoir, pause, and back. Pressing one of the first five options is performed by soft keys and sends the user to a new page page, where the user inputs numbers. The range of values is also displayed in these five pages, preferably below the soft keys, and the input of numbers is performed as mentioned in the description of figure 7, as the system checks the range and responds.

Reference is made now figure 11 schematically presents the page displayed to show the view system page for the PCA mode, according to one embodiment. It is clearly shown that the display of all numeric values is the same through all pages of the user interface, to ease on the user. The pattern is the name of the parameter, numeric value and the unit of measure at the end of the line. The first line of the page shows the name of the treatment, and the other lines show the main other parameters, especially unit drug, drug/weight ratio, reservoir, demand dose, concentration, continuous rate, dose rate, dose lockout, maximal number of dose per hour, the remaining time, bolus, bolus rate, occlusion, alarm level, authorization level, air detector (bubble detector), date, time, and the version or model of the system.

Reference is made now figure 12 schematically presents the page displayed to show the options for the Demand Dose History. In the main page for History, the user can choose between Hourly and Summary. One press on the soft key which represents Summary/Hourly makes the soft key bold, or changes the soft key any other mode. After touching one of the two optional soft keys, the user presses OK to enter the page, or cancel to return to the Options page. The summary of History shows the total number of hours, volume, and number of doses, start time, or any other parameter, only by total numbers. The Hourly page shows only the numbers of one or more hours, depends on the user's command, as the

default value is one hour, and can be changed by the user. Here, the measure of unit display is unnecessary, only the value and the parameter name.

Reference is made now figure 13 schematically presents the page displayed for Alarm Settings. There are two parameters regarding the alarm - Volume and Interval. Again, similarly to the history pages, the user presses one of the options and then presses OK or Cancel. Unlike other numeric options, as displayed both for Volume and Interval pages, here the user can not choose the exact value, but only choose from at least one value, preferably 3-7 optional values. After choosing the right value, the user presses OK or Cancel, all by pressing soft keys, the system sets the new configuration and the user is back to the Options page.

Reference is made now figure 14 schematically presents the page displayed for Errors and Faults. Each of the pages includes the name and description of the error, displayed in different lines, preferably in a certain pattern as the header informs whether it is an Error or a Fault and also presents the number of error or fault. The next line shows the alarm name and the line below shows the alarm description. The last line shows the Command options, preferably just OK ¹ or 'Go Back'. Errors and Faults, like other commands, are stored in the Events Log, which is an adapted database. The Event Log can be searched, in order to find crucial faults or analyze processes the patient experienced, such an over dose. In case of a fatal error, the user has the option to turn off or shut down the pump. This is done, in most embodiments, by continuously pushing the OK button, while the system displays the time elapsed and remains for the shut down.

Reference is made now figure 15 and 16, schematically presents the page displayed for Faults, Alarms and Error messages. Each Fault is displayed along with a number, so as to facilitate the user to in looking look for it in the user manual. In case there is no need to explain or fix the error, the system also informs the user on the next step. For example, 'Return to Service' message is displayed. It is shown that any page of Fault and Error has an OK soft key, so as to intuitively navigate from the fault page, back to the other pages.