Abstract:
User interfaces for medical perfusion systems that provide oxygenation, filtering, and recirculation of blood in connection with various medical procedures are provided. In particular, user interfaces for use with blood pumps that assist in managing alarms commonly encountered during cardiopulmonary bypass surgeries are provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims priority to U.S. Provisional Application No. 60/905,640, filed Mar. 8, 2007, the entire contents of which are incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention is directed to user interfaces for medical perfusion systems that provide oxygenation, filtering, and recirculation of blood in connection with various medical procedures. In particular, the present invention is directed to user interfaces for use with blood pumps that assist in managing alarms commonly encountered during cardiopulmonary bypass surgeries. 
       BACKGROUND 
       [0003]    Conventional perfusion systems are used to oxygenate, filter, and/or recirculate the blood of a patient during a medical procedure such as during cardiopulmonary surgeries. Such perfusion systems include a fluid conduit that removes blood from the patient during the medical procedure, a separate fluid conduit that returns blood to the patient, one or more blood pumps that pump blood through the conduits, and a plurality of sensing devices, such as flow sensors and/or level sensors associated with blood pumps. The perfusion system may also include air embolus sensors, temperature sensors, flow occluders, etc. 
         [0004]    Perfusion systems require a perfusionist operating the perfusion system to closely monitor many different parameters, and manually adjust the speeds of the various pumps in the system on a frequent basis to keep the various parameters in balance and within safe and desired limits. Alarm conditions, when they occur, require immediate, manual action by the perfusionist. Accordingly, mechanisms are needed to help the perfusionist safely, accurately, and quickly manage such alarm conditions control the perfusion system with greater safety, accuracy and speed. 
       SUMMARY 
       [0005]    The present invention provides unique user interface designs that annunciates an alarm condition, describes the nature of the alarm with indicia such as text, and provides the user with options concerning how to best manage the alarm condition. Clear visual indicators are provided to assist in managing the device and handling the alarm condition. For example, visual indicators may use the colors red and yellow to guide the user to quickly manage the machine interface during the management of alarms. 
         [0006]    In an aspect of the present invention, a method of managing an alarm condition of a perfusion system during cardiopulmonary bypass surgery is provided. The method comprises the steps of providing a user interface for the perfusion system comprising a touch screen, displaying a color coded alarm condition on the touch screen, and displaying a color coded alarm management icon on the touch screen for managing the displayed color coded alarm condition. 
         [0007]    In another aspect of the present invention, a user interface for managing an alarm condition of a perfusion system during cardiopulmonary bypass surgery is provided. The user interface comprises a touch screen, a color coded alarm condition indicator displayed on the touch screen comprising a color coded graphical portion and a color coded textual message portion for providing information related to an alarm condition, one or more color-coded alarm management icons displayed on the display screen for managing the alarm condition based on the color coded alarm condition indicator. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate several aspects of the invention and together with description of the embodiments serve to explain the principles of the invention. A brief description of the drawings is as follows: 
           [0009]      FIG. 1  is a perspective view of an exemplary pump console according to an aspect of the present invention showing a user interface and a base unit. 
           [0010]      FIG. 2  is a schematic block diagram of the pump console of  FIG. 1 . 
           [0011]      FIG. 3  is a schematic diagram of a safety module that can be used with the base unit according to an aspect of the present invention. 
           [0012]      FIG. 4  is an exemplary main screen of a user interface in accordance with the present invention. 
           [0013]      FIG. 5  is an exemplary settings screen of a user interface in accordance with the present invention. 
           [0014]      FIG. 6  illustrates a user interface in accordance with the present invention in a normal state of operation without an indication of an alert or alarm condition. 
           [0015]      FIG. 7  illustrates a user interface in accordance with the present invention showing an alert condition identified by a color coded status bar and a color coded message box and showing color coded information for managing the alert condition. 
           [0016]      FIG. 8  illustrates a user interface in accordance with the present invention showing an alarm condition identified by a color-coded status bar and a color coded message box and showing color coded information for managing the alarm condition. 
           [0017]      FIGS. 9 and 10  illustrate a user interface in accordance with the present invention showing another alarm condition identified by a color-coded status bar and a color coded message box and showing color coded information for managing the alarm condition. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]      FIG. 1  is an exemplary perspective view and  FIG. 2  is a schematic block diagram of a pump console  10  in accordance with the present invention. As shown, the pump console  10  comprises two primary components, including a base unit  12  and a user interface  14  that can communicate via communication link  13 . The pump console  10  may comprise a stand-alone centrifugal pump control system or it may comprise an add-on module to commercially available heart-lung machines or blood pumps. The base unit  12  provides functionality for controlling pump speed, monitoring flow/pressure, battery backup, and providing communications to the user interface  14 , for example. The user interface  14  includes a display  16  and user controls for operating and/or interfacing with the user interface  14 . Display  16  preferably comprises a touch display/screen or other display device that allows input to be provided to an icon displayed on the screen by touching, contacting, or otherwise identifying the icon. Components of the base unit  12  and/or user interface  14  preferably comprise microcontrollers that provide communications through an asynchronous serial interface (RS232) or suitable communications protocol. 
         [0019]    As illustrated, the base unit  12  comprises plural functional modules including a system controller module  18 , motion/pressure module  20 , flow module  22 , and safety module  24 . The safety module  24  is schematically shown in further detail in  FIG. 3  and preferably comprises a safety module bus interface  41 , system bus interface  26 , watchdog timer  28 , and motor controller servo interface  30 , which motor controller includes speed control input  39  and speed control output  37 . The safety module  24  also preferably includes interfaces to safety systems such as a bubble detector interface  32 , level sensor interface(s)  34 , and an arterial clamp interface  36 , which comprise inputs  31 ,  33 , and  35 , respectively. The bubble detector interface  32  provides an alarm to the operator when it detects the presence of bubbles or gross air in the tubing of the flow circuit. The level sensor interface(s)  34  provide an alarm or alert to the operator preferably based upon two separate level detectors placed on the patient blood reservoir. The arterial clamp interface  36  provides automated arterial line occlusion in the event of retrograde flow as determined by operator setup. 
         [0020]      FIG. 4  illustrates an exemplary main screen  38  for the user interface  14  in accordance with the present invention. In use, main screen  38 , as well as any other screen or screens of the user interface  14 , are displayed on display  16  and are preferably capable of receiving touch inputs such as with a finger or appropriate stylus. Main screen  38  is preferably configured to display information related to operating parameters such as alert and alarm status, blood flow and pump speed, line pressure, user configurable timers, safety systems (if installed), and power status, for example. 
         [0021]    An exemplary settings screen  40  of the user interface  14  is shown in  FIG. 5 . Settings screen  40  provides the capability to set parameters such as blood flow range and upper/lower alert/alarm limits, target blood flow rate with cardiac index and height/weight calculator, pressure transducer zeroing and upper/lower alert/alarm limits, three timer presets, and screen backlight intensity, for example. 
         [0022]    User interface  14  preferably comprises a system status indicator  42  positioned at the top of a desired user interface screen such as those shown in  FIGS. 3 ,  8 ,  22 ,  26 , and  27 . System status indicator  42  preferably comprises an optional color-coded status bar  44  and a color-coded system status message box  46 . The color coded status bar  44  preferably uses three colored light bars  48 ,  50 , and  52  that are associated with the operation status of the system and provide a visual cue for assessing system status when lit. Preferably first, second, and third colors such as green, yellow, and red are used for the light bars  48 ,  50 , and  52 , respectively, however any desired colors can be used. The status bar  44  and message box  46 , as shown, are preferably positioned at the top of a screen but can be positioned anywhere on a screen as desired. The intensity of the light bars  48 ,  50 , and  52  as well as any other color coded icon of the user interface can be varied to provide additional visual information such as the intensity of a condition, alert, or alarm. 
         [0023]    The user interface  14  preferably uses distinct alarm/alert sounds or audible signals to inform the user when alarm or alert conditions are present. An alarm sound preferably comprises a repeating sequence of long and short beeps. An alarm condition is more serious than an alert condition and requires a corrective action by the user. An alert sound preferably comprises a steady paced beep. 
         [0024]    In  FIG. 6 , user interface  14  is illustrated in a state of normal operation. That is, no alert or alarm conditions are active. As shown, illumination of the green light bar  48  of the system status indicator  42  indicates all systems are functioning normally and (as applicable) safety devices are enabled. In this normal state, light bars  50  and  52  are unlit or colorless. Accordingly, no action is indicated or required to keep the system functioning normally in such system state. Additionally, the system status message box  46  displays information about the highest priority alert or alarm. The user interface  14  is preferably pre-programmed so that alerts or alarms are prioritized. Preferably, the highest priority alert or alarm is displayed and when that alert or alarm is corrected the next highest alert or alarm is displayed, if any. In the normal state of operation and as illustrated in  FIG. 6 , the system status message box  46  is preferably displayed without a corresponding green color code although the system status message box  46  may be color coded if desired. That is, message box  46  can be white or grey, for example, or match the background color of other screen elements as desired. 
         [0025]    In  FIG. 7 , user interface  14  is illustrated in a state of malfunction and with an indication of an alert. An alert indicates a condition other than normal operation and that requires attention by an operator. In this case, the state of malfunction is a flow-system malfunction. An alert notification preferably includes a steady paced beep or other audible signal and illumination of the yellow light bar  50  of the system status indicator  42 , as illustrated. Light bars  48  and  52  are preferably unlit or colorless, as illustrated. Additionally, the system status message box  46  displays information about the alert and is preferably displayed with a corresponding yellow color code. The system is preferably configured so an alert or alarm condition is preferably temporarily silenced by pressing the mute button  55 , but will preferably resume after 60 seconds if the condition is not resolved or if a new alert or alarm condition occurs. The mute button  55  preferably only appears when an alert or alarm condition exists and may be color-coded if desired. 
         [0026]    The illustrated alert condition of  FIG. 7  is a flow system malfunction but any desired condition can be characterized as an alert condition. Exemplary alert conditions include those related to a low reservoir, flow rate, pressure, and clamp air pressure. An alert condition indicates a problem and typically requires a corrective action by the user. The system status message box  46  identifies the alert condition and also provides information regarding how to manage the alert condition using the words “Press Service (Wrench) Button To Acknowledge.” The alert condition can be managed by pressing the service wrench button  54 , which is also preferably color-coded, yellow with the alert condition color. Pressing the service wrench button  54  displays a log of internal system errors. An alert condition may display additional unique yellow icons to aid the user in identifying the source of the alert condition. The user interface  14  thus provides an indication of the alert condition with the yellow light bar  50  and yellow coded system status message box  46 , indication of the particular alert condition and how to manage the alert condition in the system status message box  46 , and an indication of where to manage the alert condition on the touch screen with the color coded icon (e.g., service wrench button  54 ). Any combination of colors, color intensity, sounds, and text can be used in accordance with the present invention to identify an alert condition. 
         [0027]    In  FIG. 8 , user interface  14  is illustrated in a state of alarm and with an indication of such alarm. An alarm condition is more serious than an alert condition and requires an immediate corrective action by the user. Exemplary alarm conditions relate to communications errors, bubbles in the flow circuit, and motor or pump failure. An alarm notification preferably includes a repeating sequence of long and short beeps and illumination of the red light bar  52  of the system status indicator  42 , as illustrated. Light bars  48  and  50  are preferably unlit or colorless, as illustrated. Additionally, the system status message box  46  displays information about the alarm and is preferably displayed with a corresponding red color code. The illustrated alarm of  FIG. 8  is related to detection of a bubble in the flow circuit, but any desired condition of the perfusion system can be characterized as an alarm condition. Accordingly the system status message box  46  identifies the condition and also provides information regarding how to manage the alarm with the words “Press Bubble Detector Button To Acknowledge.” The alarm condition can be managed by pressing the service bubble detector button  56 , which is also preferably color coded red with the alarm color. An alarm may display additional unique red icons to aid the user in identifying the source of the alarm condition. Accordingly, like the alert condition described above relative to  FIG. 7 , the user interface  14  provides an indication of the alarm with the red light bar  52  and red coded system status message box  46 , indication of the particular condition and how to manage the condition in the system status message box  46 , and an indication of where to manage the condition on the touch screen with the color coded icon. Any combination of colors, color intensity, sounds, and text can be used in accordance with the present invention to identify an alarm condition. 
         [0028]    In  FIGS. 9 and 10  another exemplary feature of the user interface  14  is illustrated.  FIG. 9  shows user interface  14  in a state of alarm and with an indication of such alarm provided by illumination of the red light bar  52  of the system status indicator  42 . In accordance with the present invention, the system status message box  46  displays information about the alarm and is preferably displayed with a corresponding red color code. In particular, the illustrated alarm of  FIG. 26  is related to the state of a clamp system and indicates that the clamp is closed. Accordingly, the system status message box  46  identifies the condition and also provides information regarding how to manage the alarm by pressing the open clamp button  58  which is also preferably color coded red with the alarm color. Also illustrated is a clamp status button  60  color-coded red and which is used to configure the clamp system. In  FIG. 10 , a submenu  62  of the open clamp button  58  is shown which is activated and displayed when the open clamp button  58  is pushed and which can be used to provide verification of the action of opening the clamp by selecting a confirm button  64  or a cancel button  66 . 
         [0029]    The present invention has now been described with reference to several embodiments thereof. The entire disclosure of any patent or patent application identified herein is hereby incorporated by reference. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein, but only by the structures described by the language of the claims and the equivalents of those structures.