Abstract:
The present invention comprises a printer system integral with a sedation and analgesia system having the capability to display data at spaced intervals, such as, for example, every five minutes, where the data in the previous five minutes is averaged in order to minimize the spurious impact of artifacts on the printed record. The present invention further comprises a printer system integral with a sedation and analgesia system that, upon request, prints a detailed, real time graphical display of critical parameters regarding a patient&#39;s physiology. The printer may be used with a brief memory from which an operator may request information that may have already exited an associated visual output device.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims priority under 35 U.S.C. §119(e) from U.S. Provisional Patent Application Serial No. 60/357,635, filed Feb. 20, 2002 and incorporated herein by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates in general to printers and, more particularly, to printers associated with sedation and analgesia systems.  
         BACKGROUND OF THE INVENTION  
         [0003]    In response to, among other things, market conditions and popularity amongst cost-conscious patients, out-of-hospital procedures continue to experience rapid growth. For various reasons, clinicians such as, for example, in office, ambulatory center, dental, non-hospital and hospital settings sometimes administer or supervise the delivery of sedation and analgesia without the services of trained anesthesia providers. This development has led the American Society of Anesthesiologists to issue guidelines for the delivery of sedation and analgesia by non-anesthesiologists. Because the non-hospital setting is in general not as well equipped and staffed as hospitals, malfunctions and complications (such as unintended over-medication leading to loss of consciousness and airway reflexes) may lead to severe outcomes.  
           [0004]    A sedation and analgesia system is described in commonly assigned and co-pending U.S. patent application Ser. No. 09/324,759, filed Jun. 3, 1999. This system safely provides patients undergoing painful, uncomfortable or otherwise frightening (anxiety inspiring) medical or surgical procedures with sedative, analgesic, and/or amnestic drugs in a way that reduces the risk of overmedication, in both non-hospital and hospital settings.  
           [0005]    In accordance with quality assurance practices that comprise current standards of care, and to comply with the Joint Commission Accreditation of Hospitals Organization (JCAHO) standards, many systems have been developed to print pertinent information relating to drug administration and patient physiology during a medical procedure. Many medical monitors produce frequent and significant artifactual data. When patient records are manually maintained by trained healthcare providers, this artifactual data is intelligently filtered, and thus, does not distort the medical record. However, many devices employed to automate the creation of a patient&#39;s medical record utilize print algorithms that may misrepresent the patient&#39;s true condition. Because the patient record is a critical medico-legal document, unsophisticated automated record keeping devices have not generally been well accepted by clinicians due to the possibility that machine error, software error, patient monitor error, or other error is recorded though not reflective of true patient condition. This concern that artifacts may be taken as fact has led many clinicians to discourage, or to simply abandon, the use of such devices.  
           [0006]    Other medical devices have been developed that output data via a user interface such as, for example, a computer monitor or LCD screen. These devices allow a physician or nurse to see data as it occurs in real time in order to make informed and educated decisions regarding patient care. Many of these devices lack a means of capturing information displayed on the monitor and require the displayed data to be quickly analyzed before it is continuously replaced with new incoming data. During medical procedures, a clinician may be alerted by others to the display of a potential problem on the monitor, only to view the monitor after the display indicating the potential anomaly has been overwritten by newer data. Unfortunately, once the display indicating a potential anomalous event has been overwritten, the clinician may be unable to evaluate the event in order to determine its etiology and possible significance.  
           [0007]    The concerns regarding printers that indiscriminately record all data, including artifacts, make it difficult for hospitals to comply with JCAHO standards. These standards include, for example, recording test results relevant to the management of the patient&#39;s condition, all operative and other invasive procedures performed, progress notes made by the medical staff and other authorized individuals, clinical observations, the patient&#39;s response to care, every medication ordered or prescribed for an inpatient, every medication dispensed to an ambulatory patient or an inpatient on discharge, and every dose of medication administered. If the clinician has opted not to use a printer for the aforementioned reasons, this information will have to be scribed by a nurse or attendant during a procedure, even if the attendant&#39;s time might be better allocated to direct patient care activities. The requirement that an assistant scribe the information adds a further task to be performed by the medical or surgical team resulting in an overly multi-tasked team or the requirement for additional personnel. An overly tasked team may be prone to errors resulting in irreparable damage, and the addition of personnel raises the cost of medical care. Furthermore, manual transcription may be prone to human error, especially if critical numbers reflecting patient status are inadvertently transposed or incorrectly entered.  
           [0008]    Other devices provide data printouts, but may not give a clinician enough information with which to make an informed decision as to the significance of the data printout. These devices may print out information related, for example, to an ECG illustrating an anomalous patient episode. From this information alone, it may be difficult for the clinician to determine the importance and/or clinical relevance of the event, and whether to take potentially costly steps to remedy the possible problem, or disregard a potentially life threatening event as an anomalous patient episode. Although these devices may comply, for example, with regulations for office-based anesthesia, they may not fully meet the needs of the patient and clinician.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention comprises a printer system integral with a sedation and analgesia system having the capability to display data at spaced intervals, such as, for example, every five minutes, where the data in the previous five minutes is averaged in order to minimize the spurious impact of artifacts on the printed record. By providing a truer overall picture of the patient&#39;s condition, this printer system facilitates acceptance and use of the printer compared to machines that indiscriminately record artifacts if the latter happen to coincide with the printing interval. The printer system allows the automated entry of data integral with a sedation and analgesia system in fields of a user interface selected as important in complying with JCAHO standards in order to free up personnel to focus on the actual procedure. The user interface for the printer system has means for efficiently and conveniently entering user input into the resulting printout to make notations that document or provide additional information to clarify patient conditions, automated recordation of erroneous data, manual administration of drugs, or for any other suitable reason.  
           [0010]    The present invention further comprises a printer system integral with a sedation and analgesia system that, upon request, prints a detailed, real time graphical display of critical parameters regarding a patient&#39;s physiology. The printer may be used with a brief memory, such as, for example, 15 seconds, in which an operator may request information that has exited the visual output device, for example, in the last 15 seconds. After such a request is made, the printer system provides the requester with a printout that contains several critical monitored patient parameters in order to accurately assess the significance of illustrated data. The printer may be turned on or off depending on the needs of the physician. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    [0011]FIG. 1 is an overall conceptual schematic block diagram of the apparatus in accordance with the present invention;  
         [0012]    [0012]FIG. 2 is a more detailed schematic block diagram of the printer system in accordance with the present invention;  
         [0013]    [0013]FIG. 3 is a view of an example of an interface prompt in accordance with the present invention;  
         [0014]    [0014]FIG. 4 is a view of an example of a second interface prompt in accordance with the present invention;  
         [0015]    [0015]FIG. 5 is a view of an example of a STAT printout prompt in accordance with the present invention;  
         [0016]    [0016]FIG. 6 is a view of an example of a graph printout in accordance with the present invention;  
         [0017]    [0017]FIG. 7 is a view of an example of a data printout in accordance with the present invention; and  
         [0018]    [0018]FIG. 8 is a flow chart illustrating a method in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0019]    [0019]FIG. 1 illustrates a flow chart depicting one embodiment of the present invention comprising a sedation and analgesia system  22  having user interface  12 , such as that described in commonly assigned and co-pending U.S. patent application Ser. No. 10/285,689 filed Nov. 1, 2002, controller  14 , peripherals  15 , power supply  16 , external communications  10 , printer system  11 , patient interface  17 , and drug delivery  19  where sedation and analgesia system  22  is operated by user  13  in order to provide sedation and/or analgesia to patient  18 . An example of sedation and analgesia system  22  is described in commonly assigned and co-pending U.S. patent application Ser. No. 09/324,759, filed Jun. 3, 1999 and incorporated herein by reference.  
         [0020]    The sedation and analgesia system of application Ser. No. 09/324,759 includes a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient, a drug delivery controller supplying one or more drugs to the patient, a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition, and an electronic controller interconnected between the patient health monitor, the drug delivery controller, and the memory device storing the safety data set; wherein said electronic controller receives said signals and in response manages the application of the drugs in accord with the safety data set.  
         [0021]    [0021]FIG. 2 illustrates a flow chart depicting one embodiment of printer system  11 , in cooperation with controller  14  and user interface  12 , where user interface  12  is operated by user  13 . User  13  inputs data into user interface  12  via hard buttons, soft buttons, touch sensitive buttons, a voice recognition system, or by other suitable means of data entry such as, among other things, bar code readers. User interface  12  transfers the user-entered data to controller  14  where the information is gathered into a program designed in a language such as, for example, C or C++, functioning in an operating system such as, for example, QNX. Commands are sent from controller  14  to printer controller card  23  via port  26 . Port  26  may be a parallel port, a serial port, USB, SCSI, FireWire, flexible port or other suitable means of transferring data. Printer controller card  23  is, in one embodiment, a CHARTKARD, manufactured by Parallel Systems Corporation, however printer controller card  23  may be any interface circuit suitable for transferring data from controller  14  to printer  24 . A further embodiment of the present invention comprises printer system  11  having programming in place of the presence of a printer controller board. Printer controller card  23  functions to convert data received from controller  14  into commands transmittable to printer  23 . Printer controller card  23  may be connected to printer  24  via port  25  which may be a parallel port, a serial port, a flexible port, a wireless port or by other suitable means of transferring data. Printer  24  is, in one embodiment of the present invention, a thermal micro printer, made by Seiko, however the present invention also contemplates the use of other printers suitable for use with printer system  11 . A further embodiment of the present invention comprises a detachable printer (not shown), where the detachable printer may be affixed to sedation and analgesia system  22 , or placed in any desirable position adjacent sedation and analgesia system  22 . An even further embodiment of the present invention comprises a remote printer (not shown), where the remote printer may be adapted to receive wireless commands in the form of transmission waves from sedation and analgesia system  22 , where the remote printer is adapted to function without direct connection to sedation and analgesia system  22 .  
         [0022]    [0022]FIG. 3 illustrates one embodiment of an interface prompt  27  of user interface  12  having on button  28  to activate printer  24 , off button  29  to deactivate printer  24 , cancel button  30  to return to the main user interface prompt (not shown), off button  32  to shut down one or more sub-systems of sedation and analgesia system  22 , auto button  33  to automatically commence printing in a default mode, and OK button  31  to prompt further information regarding printing. FIG. 3 shows these buttons as related to an Automated Responsiveness Test (ART) sub-system, but the buttons may be related to corresponding controls of other sub-systems of sedation and analgesia system  22 . As illustrated, interface prompt  27  may be used to turn on or off other features of sedation and analgesia system  22  such as, for example, NIBP or supplemental oxygen. The buttons  28 ,  29 ,  30 ,  31 ,  32 ,  33  may be soft buttons, hard buttons, touch sensitive, responsive to verbal commands, or may be activated in other ways commonly known in the art. The presence of the on button  28  and off button  29  give the clinician the option of activating or deactivating the printer  24  at any time during the medical procedure, or the option of disabling the printer  24  for the duration of the procedure. This option is consistent with the “clinician knows best” philosophy giving the user  13  ultimate control as to what features of sedation and analgesia system  22  are necessary for a given procedure. In one embodiment of the present invention, activating OK button  31  prompts second interface prompt  34  illustrated in FIG. 4.  
         [0023]    [0023]FIG. 4 illustrates one embodiment of second interface prompt  34  consistent with the present invention having interval buttons  35 , cancel button  36 , and OK button  37 . Buttons  35 ,  36 ,  37  may be soft buttons, hard buttons, touch sensitive, responsive to verbal commands, or may be activated in other ways commonly known in the art. Interval buttons  35  function to print readings based on the average information retained in the sedation and analgesia system  22  memory over the period specified. For example, the selection of interval button  35  denoting a five minute time period will function to print out information desired by the clinician such as, for example, information used in meeting JCAHO standards, as an average of the variables requested by the clinician over the previous five minute period. Averaging the data received from the patient interface  17  (FIG. 1) over a set period of time allows the clinician to record data necessary to meet JCAHO standards while at the same time diminishing the impact of artifacts due to monitoring errors unrelated to the patient&#39;s true condition. Interval buttons  35  may offer the clinician a range of time periods from which to choose and may be changed at any time during the medical procedure depending on the needs of the particular application. A further embodiment of the present invention comprises the use of an LED screen (not shown) into which a time recording interval may be input via a keyboard, up/down selector, or by other suitable means. Second interface prompt  34  further comprises OK button  37  to accept the activated interval button  35 , and a cancel button  36  to return to the previous prompt or main interface prompt.  
         [0024]    [0024]FIG. 5 illustrates a STAT prompt  38  having data button  39 , graphs button  40 , cancel button  41 , and OK button  42 . Buttons  39 ,  40 ,  41 ,  42  may be soft buttons, hard buttons, touch sensitive, responsive to verbal commands, or may be activated in other ways commonly known in the art. STAT prompt  38  may be selectable on the main user interface (not shown) at all times, may be activated by initiating a STAT command on another prompt, or may follow further printer prompts such as, for example, second interface prompt  34 . In one embodiment of the present invention, STAT prompt  38  functions to provide a clinician with the ability to print out a 15 second (or some other suitable time) medical history depicting data received from the patient interface  17  in graph form if graphs button  40  is selected and in data form if data button  39  is selected. STAT prompt  38  provides the clinician, nurse, or other operator with the ability to print data containing anomalies that may require further examination. The STAT prompt  38  system used in cooperation with second interface prompt  34  allows for JCAHO data to be recorded that minimizes the impact of artifacts, yet at the same time provides the clinician ultimate control in printing out the aforementioned artifacts to determine if they have any relevance to the medical procedure at hand. Details of STAT graph printout  43  (FIG. 6) will be further discussed below. The present invention further comprises STAT prompt  38  having a variable time function, where the clinician may select a specific amount of time elapsed to print such as, for example, the last 10 seconds, 5 seconds, or any other desirable time period. A further embodiment comprises the ability to print the STAT printout  43  during the entire procedure depending on the needs of the clinician.  
         [0025]    [0025]FIG. 6 illustrates one embodiment of STAT graph printout  43  in accordance with the present invention in the form of graphs  44 , (in situations where graphs button  40  was pressed on STAT prompt  38 ) where the graphs  44  display the recent history of critical patient parameters. FIG. 6 illustrates graphs  44  comprising ECG graph  45 , pulse oximetry graph  46 , and carbon dioxide analysis graph  47 , where graphs  44  illustrate real time data in one-to-one relationship with one another in order to provide a fast and efficient means of comparing data from one graph  44  with information from another. Comparative data gives the clinician the opportunity to determine whether an anomaly may be significant due to its relation to a number of other measurements of physical parameters. This system provides the operator with “orthogonal redundancy”, or a system of multiple checks and balances related to a single measured parameter in order to evaluate information in the context of interrelated data. Further embodiments of STAT printout  43  comprise the inclusion of data numbers from which the graph is constructed, graphs relating to parameters such as, for example, drug effect site concentration and/or blood pressure, time axes, concentration axes, input physician orders, and/or other data beneficial in characterizing a medical event. A further embodiment of the present invention comprises the exclusion of one or more graphs  44  illustrated in FIG. 6.  
         [0026]    [0026]FIG. 7 illustrates one embodiment of interval data (numerical) printout  48  in accordance with the present invention having STAT data printout  49 . In one embodiment of the present invention interval data printout  48  is initiated by interface prompt  27  and second interface prompt  34  and functions to print data related to JCAHO standards such as, for example, patient name input  50 , date input  51 , time readings  52 , parameter readings  53 , data headings  54 , and notes input  55 . As illustrated in FIG. 7, data related to selected parameters may be printed every five minutes as seen at 8:00 and 8:05 in order to record data that averages data recorded over the print, for example, five minute interval. Averaging this data minimizes the significance of artifacts, as previously discussed, while complying with JCAHO standards. STAT data printout  49  may be activated by the clinician at any time during the procedure and provides a “Current” reading of desired parameters over a given time interval that may be displayed as an average for a shortened period such as, for example, 15 seconds, or may be a real time spot check printout. This data may be used independent of, or in cooperation with, the STAT graph printout  43  in order to characterize data. In one embodiment of the present invention final data printout  56  provides the clinician with an overall mean for data acquired during the procedure. Time readings  52  may be established by the operator via second interface prompt  34  and inputting the desired time interval. Parameter readings  53  and data headings  54  may be entered or removed by the clinician in order to include or exclude data relevant or irrelevant to the medical application, respectively. Notes input  55  allows for the operator to input data relevant to the procedure that may not be captured by the pre-selected data parameters. Data may be entered such as, for example, drug administration, patient response data from, for example, the automated responsiveness test disclosed in commonly assigned and co-pending U.S. patent application Ser. No. 10/329,763 filed Dec. 27, 2002, or factors helpful in meeting JCAHO standards. It will be obvious to one of ordinary skill in the art that any parameter relevant to a medical procedure may be incorporated into interval data printout  48  and that any such feature may be included or omitted from the interval data printout  48  at the discretion of the clinician.  
         [0027]    [0027]FIG. 8 illustrates a flow chart depicting a method of printing data monitored by a sedation and analgesia system comprising the steps of acquiring data from physiological monitors and sub-systems  100 , transferring data to controller  14  of a sedation and analgesia system  200 , processing data by controller  14  of a sedation and analgesia system  300 , transferring processed data to a printer system  400 , and printing data  500 . Acquiring data from physiological monitors and sub-systems step  100  comprises acquiring data from patient interface  17  (FIG. 1), power supply  16 , peripherals  15 , user interface  12 , external communications  10 , printer system  11 , drug delivery  19 , or other features connectable to software controlled controller  14 .  
         [0028]    Transferring data to controller  14  of a sedation and analgesia system step  200  comprises the transfer of data to controller  14  of sedation and analgesia system  22  via parallel port, serial port, USB. SCSI, Firewire, A/D converter, flexible port, wireless output, or by other suitable means of transferring data.  
         [0029]    Processing data by controller  14  of a sedation and analgesia system step  300  comprises the processing of data by software controlled controller  14  of a sedation and analgesia system  22  by utilizing programs inherent or incorporated into software controlled controller  14  desirable for use with a particular medical application such as, for example, printer specifications, data heading  54 , and/or time readings  52 .  
         [0030]    Transferring processed data to a printer system step  400  comprises transferring data to printer system  11 , where data may be transferred via parallel port, serial port, USB port, Firewire, SCSI, flexible port, or by other suitable transference means.  
         [0031]    Printing data step  500  comprises printing a hard copy of data from a printer  24 , where the printout from printer  24  may be interval data printout  48 , STAT data printout  49 , STAT graph printout  43 , or other printout desirable for a medical procedure.