Patent Application
20080307353
The invention relates to a medical apparatus and to a user interface for a medical apparatus. The medical apparatus of the invention could be an apparatus intended for the extracorporeal treatment of blood, for instance by hemodialysis, hemofiltration, hemodialfitration, ultrafiltration, plasmapheresis or an apparatus for processing whole blood and/or blood components.
Blood treatment apparatus and similar medical devices comprise an extracorporeal circuit, provided with at least one blood treatment or blood processing unit, one tube, connecting a blood removal zone to said unit, and a second tube, extending downstream of the treatment or processing unit towards a blood return zone to the patient or towards a blood/blood components collection zone. Blood is moved from the patient or donor to the treatment or processing unit via pumps or other actuators controlled by the machine.
In case the machine is for instance a hemodialysis apparatus, then for achieving the required treatment of blood, an adequately prepared dialysis liquid shall be sent to the treatment unit, and water removal through the treatment unit membrane as well other machine parameters shall be controlled. Depending upon the type of hemodialysis machine and upon the type of treatment, a user can have the possibility to set a number of parameters in order to impose a specific prescription to a patient, such as for instance: flow rates of the various liquids, temperatures and conductivity of the liquids, concentration of the liquids used during treatment, flow rates of any anticoagulants used and delivered during treatment, pressures in the fluid conduits, net liquid removal rates of plasma water from whole blood and so on.
It is therefore evident that users (the patient himself, a physician, a nurse) have normally a plurality of parameters to set before or even during the process performed by the medical apparatus.
In this situation easy and safe data entry as well as reliable data storage and transmission are particularly important in machines as blood treatment machines or blood processing apparatus where the process executed by the machine acts on a patient's or donor's blood. Particularly, in case of treatment of patients suffering from kidney failure, the patient is constantly connected to the machine with the serious risk that any failure in entering or in actuating a prescription could have negative impacts on the treatment delivery and on patient's health.
It is also to be noted that when setting up a blood treatment machine or similar apparatus, the user has to enter a relatively big number of treatment parameters and of machine operation parameters. This is accomplished giving the user possibility of navigation through various data entry screens wherein parameters of the same typology or parameters referring to a common context can be entered.
In this situation several technical solutions have been developed in the past in order to render parameters values data entry in blood treatment or blood processing apparatus relatively easy and reliable.
A data entry user interface of general purpose and not specifically designed for the medical field is known from U.S. Pat. No. 5,546,582.
A first known method for entering data in a dialysis machine is described in U.S. Pat. No. 5,247,434. This method comprises the following steps:
(a) providing a touch screen interface with an indicium thereon corresponding to a treatment parameter;
(b) touching the indicium;
(c) in response to said touching, invoking a data entry pad on a region of the touch screen;
(d) entering a parametric value corresponding to the treatment parameter by touching one or more buttons of the data entry pad;
(e) touching a first region of the data entry pad to signal entry of the parametric value;
(f) displaying on the touch screen a button soliciting verification of the newly entered parametric value;
(g) touching the button soliciting verification; and
(h) in response to steps (b)-(g), causing the parametric value corresponding to the treatment parameter to be changed.
In other words before really implementing a change a user is solicited to verify the newly entered parameter and to press a button confirming the change.
The same patent also discloses a method for entering variable parameters, i.e. parameters that can vary in the course of time during treatment.
More in detail U.S. Pat. No. 5,247,434 shows a method of programming a time-varying parameter comprising the steps:
(a) providing a touch screen interface;
(b) displaying on the touch screen first and second axes, the first axis corresponding to the time-varying parameter, the second axis corresponding to time;
(c) touching the touch screen at a plurality of points to define points on a parameter-versus-time curve;
(d) presenting on the touch screen a series of bars corresponding to said curve;
(e) selecting one of said bars for alteration;
(f) displaying on the screen a numeric parameter corresponding to the selected bar;
(g) touching the screen at first or second locations to increase or decrease, respectively, the displayed numeric parameter and thereby alter the value of the numeric parameter to which the selected bar corresponds;
(h) touching the screen at a third location to signify completion of steps (b)-(g); and
(i) storing data corresponding to the bars in a memory to which the process-control system can refer in changing the time-varying parameter with time.
Document U.S. Pat. No. 5,326,476 teaches a further method for entering a time variable parameter, ultrafiltration in particular, in a hemodialysis machine, having a programmable memory and having ultrafiltration capability, so as to enable the machine to perform ultrafiltration of fluid from a patient according to a time-variable ultrafiltration profile. The method disclosed in U.S. Pat. No. 5,326,476 comprises the following steps:
This method allows the user to enter a profile curve and to move the ultrafiltration profile along the ordinates so as to achieve the desired integral value in the desired time frame.
A further user interface system for a dialysis machine is known from document U.S. Pat. No. 5,788,851 and comprises:
The above system is therefore using two processing units to avoid that unsafe parameters values are entered into the machine.
It is also known from U.S. Pat. No. 6,811,707 using a dialysis machine wherein after entry of a value for a parameter the value is stored in at least two different memory locations connected to corresponding separate main control units. At predetermined intervals of time, one of the units sends the dialysis treatment parameters values stored in its memory to the other unit. The values are then compared and an alarm signal generated if the values of the same parameters in the two memories of the two units do not coincide with each other.
Finally it is known to adopt on dialysis machines a visualization of both the value set by the user for a parameter and the value actually achieved by the machine for the same parameter. This double visualization is however done in a way such that the user has to navigate through several menus or displays of the user interface to have access to both the set information and the actually measured parameter value.
While the above disclosed systems and methods served to give the user possibility to enter data in a relatively easy manner and/or served to reduce data entry errors or data memorization errors, the present invention aims to further improve ease and reliability in data entry procedures for medical devices and particularly for blood treatment or blood processing machines where easy and intuitive navigation is essential to speed up and render reliable setting of machine.
In this context, the invention aims to offer a reliable and easy system for navigation through the plurality of screen a user shall access in order to complete a medical apparatus set up procedure and/or in order to visualize all the information typically required when working on complex medical devices.
In particular, the invention aims to provide the user with an improved navigation system particularly for touch screen based user interfaces of medical apparatus wherein the user is provided with clear information concerning the hierarchical structure of the interface and of the various screens and environments that the user interface allows to access.
In accordance with a further aspect of the invention, it is an aim of the invention providing users with easy to access and read information relating to both set values and measured values for parameters.
The above aims are reached by a medical apparatus, by a method for setting up a medical apparatus and by user interface for a medical apparatus according to the appended claims. Further characteristics and advantages will better emerge from the following description in relation to some preferred but non-exclusive embodiments of an apparatus according to the invention.
The description will be made with reference to the figures of the accompanying drawings, provided by way of non-limiting example, in which:
With reference to the figures, reference number 1 denotes a medical apparatus.
The medical apparatus of the shown embodiment is a machine for the extracorporeal treatment of blood. Of course the medical apparatus of the invention could alternatively be a blood processing device or a blood component preparation device or other medical apparatus for fluid delivery/collection.
The apparatus shown in the enclosed drawings comprises a module 2 for preparing dialysis liquid to be sent into a first chamber 3 of a blood treatment unit 4, which is formed by a casing defining at least two chambers 3, 5 separated by a semipermeable membrane 6. The dialysis preparation module 2 includes tubing 7 bringing dialysis liquid to the first chamber inlet, while a waste line 8 receives spent liquid exiting via an outlet of the first chamber. In detail, the module 2 includes one or more concentrate containers 9, 10 delivering concentrated solutions, via respective lines 11, 12 and upon the action of respective concentrate pumps 13, 14, into the tubing 7 thereby properly mixing water coming from a source 15 with said concentrates and obtaining the dialysis liquid. Conductivity or concentration sensors 16, 17 can be provided on tubing 7 downstream each respective concentrate line. Said sensors provide control signals to a control system 18 which is responsible to then act on the concentrate pumps. A pump 19 is generally operating on tubing 7 and a pump 20 on the waste line 8. Of course different alternative embodiments can be envisaged to bring dialysis liquid to the treatment unit with appropriate chemical and physical properties. For instance pre-prepared dialysis liquid bags could be used with no need of online preparation of dialysis liquid starting from concentrates and water. Fluid balance sensors, for instance a first and a second flow-meter 21, 22, operating on tubing 7 and on waste line 8 respectively, are used and are connected to the control system to provide signals necessary for regulating at least one of pumps 19, 20. Of course other fluid balance systems can be used: scales for instance or balance chambers.
When the apparatus is in use, an extracorporeal blood circuit is connected to the second chamber 5. The extracorporeal circuit usually comprises at least an access branch 23 extending between a blood removal zone 24 from a patient or donor and the treatment unit 4, at least a return branch 25 extending downstream of the treatment unit, between the second chamber and a return zone of the blood to the patient; a peristaltic pump 26 is operatively associated to a length of pump tube of the extracorporeal circuit access branch. A clamp or other closure device 27 can operate on the blood return branch 25, typically downstream from a gas separator 28.
Usually, at the removal and return branches of the blood to or from the patient, access means are provided to the cardiovascular system of the patient, for example constituted by needles of appropriate sizes, catheters or accesses of different types. One or more liquid infusion lines could be provided connected at one end to an infusion liquid source (a bag or in-line infusion liquid preparation system) and at the other end to the extracorporeal circuit, or directly to the patient or donor.
Other sensors, such as pressure sensors 29, can be provided either on the extracorporeal circuit and/or on the dialysis liquid side of the apparatus.
The medical apparatus 1 can of course include other components, which are not herein disclosed as they are not relevant for the purpose of the present invention.
The apparatus 1 presents at least a user interface 30 for enabling setting of a plurality of parameters pertinent to operation of said apparatus or pertinent to a treatment to be performed by said apparatus. While the user interface herein disclosed is connected with and part of the apparatus 1, it shall be understood that the user interface 30 could be manufactured and sold separately and then connected to a medical apparatus.
The user interface 30 includes a touch-screen 31, which allows interaction with the user interface, for instance selection of certain parameters, visualization of values of said parameters and display of other information as it will be here below in detail described.
The activity of the user interface is determined by control system 18, which is connected to the user interface, is responsive to actions by a user on said user interface, and controls operations of the medical apparatus 1 by acting on a plurality of actuators (such as pumps 12, 13, 19, 20, 27, valve 27 and others) and by receiving signals by a plurality of sensors (such as for instance sensors 12, 13, 21, 22, 29 etc.).
The control system includes a main control unit, connected to the user interface 30, and at least a memory connected to the main control unit. From a technical point of view the main control unit includes at least microprocessor, while the above-mentioned memory can be in a single physical memory or in physically separated memory devices.
The control system 18 is programmed (for instance by loading a program in the memory which then is executed by the CPU) for carrying out the following steps.
First the control system defines on screen 31 an operating region 32, where a number of working displays can be displayed, and a navigation region 33, where a number of navigation keys can be displayed (see
The operating region 32 of the embodiment in
The navigation region of the non-limitative embodiments shown is in the bottom part of the screen and contains a plurality of navigation keys 35.
Of course the relative positions of regions 32, 33 and 34 could be differently arranged without departing from the scope of the invention. The control system displays in the operating region a plurality of working displays 36, each including one or more indicia, such as touch buttons or touch icons 37, which can be selected to access particular submenus and/or for selecting a parameter or a group of parameters for successive modification of the value(s) thereof.
In practice, the medical apparatus can be in different operating modes, for instance by way of non-limiting example idle mode, setup mode, priming mode, treatment (or dialysis) mode, and rinse-back mode. The status region 34 identifies in a band 34a information relating mode, while the operating region is accessible to the user for entering commands or for modifying settings of one or more parameters (see
The control system is programmed to associate to each of said number of navigation keys 35 a corresponding working display 36 so that each working display is selectable and displayable in the operating region upon selection of the corresponding navigation key. In other words the control system links the navigation key to one corresponding working display and therefore loads from a memory and displays on the operating region of the screen the working display associated to the navigation key selected by the user. Moreover the control system organizes a plurality of navigation keys and corresponding working displays according to a multi-level hierarchical organization where one root is present an where, upon selection of the navigation keys, it is possible for the user to access the several branches and sub-branches deriving from the root.
In this hierarchical organization the following relations are defined:
The control system is, in use, programmed to display in the navigation region at least the following keys:
The control system of the embodiment shown is in detail programmed to manage navigation based on the following rules (other embodiments could adopt only part of the following rules):
A possible way of working of a control system in accordance with the invention in response to actions of the user on a key is described in below table referring to
In order to move from the screen of
As shown in the figures, the keys 38 selected by the user are visually differentiated compared to the other keys in the navigation region and selection of said keys determines, in the operating region, displaying of at least the working display 36 associated to the selected key.
As already mentioned, the control system comprises a microprocessor based control unit, which is programmed to display the selected key in a manner visually differentiated compared to the sibling keys, the son-keys and to the ancestors-keys. Moreover both the sibling and the son-keys are displayed in a manner visually differentiated compared to the ancestor-keys.
Furthermore, the control unit is programmed to keep track of the group of ancestors-keys that need to be selected to allow access to and display of the selected key; the control system displays said group of ancestor-keys during the key display step.
Referring again to
To further enhance an immediate and intuitive perception by the user during the keys display step, the control unit is programmed to display the group of ancestor-keys and the group of son-keys (or of sibling keys if the selected key has no son-keys) in opposite and adjacent positions relative to the selected key, as again visible in
Again referring to the embodiment of the enclosed figures, it is shown that the control system is programmed to associate to each of said keys a number of variable properties including: a key background 35a, a key shape 35b, and a key identifier 35c (this latter is not necessarily always present).
In detail, during the keys display step the control system is programmed to display the key background 35a in a first condition, to indicate a selected key, to display the key background 35a in at least a second condition visually differentiated from the first condition, to indicate son-keys or sibling keys. The control system can also display the key background 35a in a third condition visually differentiated from the first and second conditions, to indicate ancestor-keys. The key background conditions can be differentiated by the colour/tone of the key or of a portion of the key, or by appropriate texturing and or rendering of the key or of a portion of the key. In the enclosed embodiment three different colours or tones (depending as to whether the screen allows use of colours or not) have been used: one for identifying the selected key, one for the son-keys and one for any ancestor keys. Sibling keys background is the same as son-keys background.
Notice that in principle a fourth background (colour/tone or texturing or rendering) could be used to differentiate son keys and sibling keys. This has not been adopted in the enclosed embodiment since if a selected key has son-keys, then any possible sibling key of the selected key is not displayed.
Moreover, during the keys display step, the control unit is programmed to vary also the key shape 35b depending upon the circumstances: ancestor-keys are displayed in a first shape and son-keys in a second shape visually differentiated from the first shape. Furthermore the control unit is programmed to configure the selected key according to said first shape, if the selected key has selectable son-keys (see
As shown in the embodiments of the attached figures, each key is tab-shaped: in such a case, the first shape is a first parallelogram and the second shape a second parallelogram. This second parallelogram has two parallel sides, both parallel to two corresponding parallel sides of the first parallelogram, and two sides oriented transversally relative to corresponding two parallel sides of the first parallelogram. Basically the parallelogram shaped tabs can have two shapes, which are different for the inclination of two of their four sides.
Once again, the keys shape namely the inclination of the tabs in the shown embodiments is used to help identify the tab hierarchy. If the selected tab has son-keys, it and all tabs representing higher levels in the hierarchy are inclined according to the same angle. Levels lower than the selected tab have inclination that is the mirror image of the selected tab. If a tab has no children, its inclination does not change when it is selected.
Of course keys shaped according to two different shapes could be obtained by modifying the length of one or both the dimensions of tabs, or in other equivalent manner if non-tab shaped keys are being used. For instance tabs or keys having asymmetric shape could serve for the purpose of differentiating two series of keys/tabs.
Finally the control unit is programmed to display a key identifier 35c, which can be one in the group comprising an icon, a wording, or an alphanumeric representation, and wherein during the keys-display step the key identifier is displayed on the key surface for describing the function of or the information contained in the working display associated to each respective key.
A further feature of the present invention provides for the control system being programmed for identifying if one or more of the keys, which are displayed together with the selected key, i.e. son-keys if any or sibling keys, present on their turn respective son-keys. Notice that son-keys of son-keys (or of sibling keys) of a selected key are hidden when displaying the selected key in the navigation region. However, the control system is programmed to display a sublevel-indicium 35d on each son-key (or sibling key) having respective son-keys; in this way a user can have a perception not only of the number of son-keys or sibling keys selectable after having selected a certain key but also an information as to whether the son keys (or the sibling keys) have respective son-keys one level below (see
In practice, referring for instance to
The control system detects selection of one son-key and transforms the selected son-key into a newly selected key, while transforming the previously selected key into an ancestor-key (see
According to a possible embodiment the screen is a touch screen including said operating and said navigation regions; in this case the control unit allows selection of a key by detecting a touching of the corresponding area delimited by the key in the navigation region. Other techniques for key selection could be possible, for instance adopting a mouse or a stick cooperating with a pointer on screen.
As mentioned, when one key is selected at least one of said working displays is invoked on screen showing one or more indicia for identifying a parameter a user intends to modify. In
The control system is programmed for detecting touching of indicium 37. Touching of the indicium signifies selection of the indicium, identifies the parameter a user intends to modify (for instance in
Alternatively to what above described the setting of a new value can be done as follows. The parameter is selected by a touching of indicium 37 on the active working display, and then in response to said touching, at least two set buttons and an enter key are activated on the touch screen working display (these keys could also be always available and active if enough room is available on the working display); then the user interface is controlled so that setting a of a new parametric value corresponding to the treatment parameter is obtained by touching one or more times the mentioned buttons (which can be shaped as arrow keys or + and − keys) and by detecting the touching of said enter key for signifying setting has been completed.
Referring to the embodiments shown, the interface 30 is associated to the extracorporeal blood treatment apparatus 1 and the parameters that can be selected and modified are one or more selected in the group comprising:
Temperature of the dialysis liquid,
Conductivity of the dialysis liquid,
Electrolytes concentration of the dialysis liquid,
Flow rate of the dialysis liquid,
Flow rate of the spent dialysate,
Flow rate of the blood in the in one of said tubing,
Ultrafiltration rate through the semipermeable membrane,
Net weight loss rate,
Treatment time,
Weight loss,
Anticoagulant delivery rate and mode,
Infusion rate of substitution solution,
Infusion volume of substitution solution.
Given the number of parameters involved in the machine setup and configuration, the user interface and the navigation concept of the invention result in a great enhancement in term of easy, quick and reliable data entry.
According to another aspect of the invention, which could be combined to the above features but also constitute a separate and independent concept, the plurality of parameters which can be set by the user through the user interface include a sub-group of parameters which are displayed as follows. This subgroup of parameters include one or more of the following parameters: treatment time, total weight loss (target loss in
Moreover, in case the indicium is related to one of parameters of said sub-group, the touch sensitive area of the button includes one or more of the following display regions:
In this way the user selects the parameter by touching the button, modifies the set value for the parameter, and has on the surface of the same button both visualization of the setting and of the current real value for the same parameter. This enhances usability as the operator has both displays in the region of his/her maximum attention, i.e. the touch sensitive area, which requires the touch to start the parameter value modification sequence. Moreover since, the two values are contemporaneously and closely displayed the user has immediate feedback as to whether the machine reacts or not to the new setting with no need of any other navigation through the interface screens.
The invention also concerns a software program comprising instructions which, when executed by the main control system of the apparatus 1 or of the user interface, programs the control system to execute the steps which have been already disclosed in the chapter ‘user interface’ and therefore not herein repeated.
More in particular the software program is able to program the control system associated to a user interface either of the above medical apparatus 1 or associated to a treatment apparatus of other nature so that the control system of the user interface or of the apparatus is programmed for executing the following main steps:
Of course the software program can program the apparatus or the user interface control system to also execute each one of the other steps already described in the chapter ‘user interface’ and not here below repeated.
The software program can be stored in any adequate support and then sold separately from the medical apparatus 1. In practice the software program could be stored on a magnetic recording support (for instance an hard disk, a cassette, a floppy disk, etcetera), or on an optical recording support (DVD or CD or other), on an electrical or electromagnetic carrier signal (if for instance the program is sent via a network), or on a computer readable memory (ROM, EPROM, RAM), or other convenient support memory device and then associated to the machine control system which running the program stored on said support is then programmed to render available a user interface having the features above described.
Finally it forms part of the invention the method for setting up a medical apparatus of the type including at least a user interface with a screen (for instance a touch screen) for enabling setting of a plurality of parameters pertinent to operation of said apparatus or pertinent to a process to be performed by said apparatus.
The method of the invention comprises the following steps:
To render the navigation intuitive and to give an immediate and clear perception of the navigation in the multilevel environment, during the keys display step the selected key is displayed in a manner visually differentiated compared to the son-keys and to the ancestors-keys and the son-keys are displayed in a manner visually differentiated compared to the ancestors-keys.
According to an aspect of the invention, the method provides for a step of keeping track of the group of ancestors-keys to be previously selected to then allow display of the selected key. This group of ancestor-keys is displayed during the key display step in a position adjacent to the selected key. In detail, the closer the level of the ancestor key to the level of the selected key, the closer said ancestor key is displayed to the selected key. To further enhance usability ancestor-keys 40,41 and son-keys 139 are displayed in opposite and adjacent positions relative to the selected key.
According to a further aspect of the invention the method provides for associating to each of said keys a number of variable properties including: a key background 35a, a key shape 35b, and a key identifier 35c.
In detail, during the keys display step the method provides for displaying the key background 35a in a first condition, to indicate a selected key, for displaying the key background 35a in at least a second condition visually differentiated from the first condition, to indicate son-keys, and for displaying the key background 35a in a third condition visually differentiated from the first and second conditions, to indicate ancestor-keys. The key background conditions can be differentiated by the colour of the key or of a portion of the key, or by appropriate texturing and or rendering of the key or of a portion of the key. In the enclosed embodiment three different colours have been used to identify a selected key, a son key and an ancestor key respectively.
Moreover, during the keys display step, the key shape 35b can also be changed depending upon the circumstances: ancestor-keys are displayed in a first shape and son-keys in a second shape visually differentiated from the first shape. Moreover the selected key can be configured according to the first shape, if the selected key has selectable son-keys, or according to said second shape, if the selected key has no selectable son-keys. The method provides for presence of sibling navigation keys: sibling keys are keys at the same level of the selected key in the hierarchical organization of the user interface. In the embodiment of the invention of the attached figures sibling keys are displayed only if the selected key has no son-keys. Said sibling keys are displayed in said second shape and with the same background colour of the son-keys. As shown in the embodiments of the attached figures and as mentioned when describing the user interface product, each key is tab-shaped: in such a case, the first shape is a first parallelogram and the second shape a second parallelogram. This second parallelogram has two parallel sides, both parallel to two corresponding parallel sides of the first parallelogram, and two sides oriented transversally relative to corresponding two parallel sides of the first parallelogram.
Basically the parallelogram shaped tabs can have two shapes, which are different for the inclination of two of their four sides. Of course keys shaped according to two different shapes could be obtained by modifying the length of one or both the dimensions of tabs, or in other equivalent manners if non-tab shaped keys are being used.
Finally a key identifier 35c, for instance an icon, a wording, or an alphanumeric representation, can be displayed on the key surface for describing the function of or the information contained in the working display associated to each respective key.
A further feature of the present invention provides for identifying if one or more of said son-keys or sibling keys present on their turn respective son-keys. In the hierarchical organization son keys of son keys (or of sibling keys) are hidden when displaying the selected key in the navigation region. However, the control system is programmed to display an indicium, herein defined as indicium 35d, on each son-key or sibling key having second level son-keys so that a user can have a perception not only of the number and type keys selectable after having selected a certain key but also an information as to whether these keys have respective son-keys below (see
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB2005/002516 | 8/25/2005 | WO | 00 | 2/21/2008 |
