Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application relates to and claims the benefit of prior U.S. Provisional Application No. 60/846,471, filed Sep. 22, 2006, entitled Modular Patient Monitor, incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     Pulse oximetry is a widely accepted continuous and non-invasive method of measuring the level of arterial oxygen saturation in blood. A typical pulse oximetry system has a sensor, a patient monitor and a patient cable. The sensor is placed on a patient fleshy tissue site, usually on the fingertip for adults and the hand or foot for neonates and connected to the patient monitor via the patient cable. The sensor provides a sensor signal detected from the patient tissue site to the patient monitor. The patient monitor displays the calculated data as a percentage value for arterial oxygen saturation (SpO 2 ), as a pulse rate (PR) and as a pulse waveform (plethysmograph or “pleth”). 
     SUMMARY OF THE INVENTION 
     A modular patient monitor provides a multipurpose, scalable solution for various patient monitoring applications. In an embodiment, a modular patient monitor utilizes multiple wavelength optical sensor and acoustic sensor technologies to provide blood constituent monitoring and acoustic respiration monitoring (ARM) at its core, including pulse oximetry parameters and additional blood parameter measurements such as carboxyhemoglobin (HbCO) and methemoglobin (HbMet). Pulse oximetry monitors and sensors are described in U.S. Pat. No. 5,782,757 entitled Low Noise Optical Probes and U.S. Pat. No. 5,632,272 entitled Signal Processing Apparatus, both incorporated by reference herein. Advanced blood parameter monitors and sensors providing blood parameter measurements in addition to pulse oximetry are described in U.S. patent application Ser. No. 11/367,013, filed Mar. 1, 2006 entitled Multiple Wavelength Sensor Emitters and U.S. patent application Ser. No. 11/367,014, filed Mar. 1, 2006 entitled Non-Invasive Multi-Parameter Monitor, both incorporated by reference herein. Acoustic respiration sensors and monitors are described in U.S. Pat. No. 6,661,161 entitled Piezoelectric Biological Sound Monitor with Printed Circuit Board and U.S. patent application Ser. No. 11/547,570 filed Oct. 6, 2006 entitled Non-Invasive Monitoring of Respiration Rate, Heart Rate and Apnea, both incorporated by reference herein. 
     Expansion modules provide blood pressure BP, blood glucose, ECG, CO 2 , depth of sedation and cerebral oximetry to name a few. The modular patient monitor is advantageously scalable in features and cost from a base unit to a high-end unit with the ability to measure multiple parameters from a variety of sensors. In an embodiment, the modular patient monitor incorporates advanced communication features that allow interfacing with other patient monitors and medical devices. 
     The modular patient monitor is adapted for use in hospital, sub-acute and general floor standalone, multi-parameter measurement applications by physicians, respiratory therapists, registered nurses and other trained clinical caregivers. It can be used in the hospital to interface with central monitoring and remote alarm systems. It also can be used to obtain routine vital signs and advanced diagnostic clinical information and as an in-house transport system with flexibility and portability for patient ambulation. Further uses for the modular patient monitor are clinical research and other data collection. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A-E  are top, side, front, right and back views of a modular patient monitor; 
         FIGS. 2A-B  are front and perspective views of a handheld monitor; 
         FIG. 3  is a docking station multiple parameter display; 
         FIG. 4  is an illustration of a modular patient monitor having 90 degree rotation with corresponding display rotation; 
         FIGS. 5A-C  are top, front and side views of a monitor cartridge; 
         FIGS. 6A-E  are top, side, front, right and back views of another modular patient monitor embodiment having alternative cartridge embodiments; 
         FIGS. 7A-C  are top, front and side views of an alternative cartridge embodiment; 
         FIGS. 8A-E  are a front and various back views of yet another modular patient monitor embodiment having a shuttle, including a display and control; a docked shuttle; a docked shuttle with an undocked handheld; an undocked shuttle; and a shuttle having a handheld; 
         FIG. 9  is a modular patient monitor side view of a further modular patient monitor embodiment having a shuttle without a docking handheld; 
         FIGS. 10A-C  are side views and a back view, respectively, of an additional modular patient monitor embodiment having dual dockable handhelds; 
         FIGS. 11A-C  are illustrations of a tablet-configured handheld monitor; 
         FIGS. 12A-D  are front perspective, top, front and side views of an alternative handheld embodiment; 
         FIGS. 13A-B  are front perspective views of an alternative handheld embodiment plugged into, and removed from, a charger; 
         FIG. 14  is a perspective view of upgrade and legacy handhelds installable into a legacy docking station directly or via a docking station adapter; 
         FIGS. 15A-B  are closed and opened views, respectively, of a notebook-style modular patient monitor embodiment having a foldable display; and 
         FIG. 16  is a perspective view of a flat panel display docking station. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIGS. 1A-E  illustrate a modular patient monitor embodiment  100  having a two-piece modular configuration, a handheld  200  unit and a configurable docking station  101 . The handheld  200  docks into a handheld port  110  of the docking station  101 , providing the modular patient monitor  100  with two-in-one functionality. In particular, the handheld  200  provides a specific set of clinically relevant parameters. The docking station  101  supports various parameters that are configured to specific hospital environments and/or patient populations including general floor, OR, ICU, ER, NICU, to name a few. Further, the docking station  101  has module ports  120  that accept plug-in expansion modules  500  for additional parameters and technologies. The handheld  200  docked into the docking station  101  allows access to all available parameters providing maximum connectivity, functionality and a larger color display  300 . The modular patient monitor  100  provides standalone multi-parameter applications, and the handheld  200  is detachable to provide portability for patient ambulation and in-house transport. 
     As shown in  FIGS. 1A-E , the docking station  101  has a dashboard  130 , with a trim knob  140  and buttons  150  so as to support system navigation and data entry. The trim knob  140  is a primary means for system navigation and data entry with an option of a keyboard and mouse as a secondary means. 
     The docking station  101  also has a power supply module  160  and connectivity ports  170 . The handheld  200  mechanically attaches to and electrically connects to the docking station  101  when docked, such that the two devices function as one unit and both the handheld display  210  and the docking station display  300  provide user information. In an embodiment, the handheld  200  docks on a docking station side such that the handheld display  200  is visible from that side of the docking station  101  ( FIG. 1D ). In addition, the docking station  101  has one or more module slots  120  that accommodate external modules  400 , as described with respect to  FIGS. 4A-C , below. 
     Also shown in  FIGS. 1A-E , controls of the docking station  101  take precedence over those of the handheld  200  when docked. However, the handheld buttons  220  also work for back up purposes. In an embodiment, buttons  150 ,  220  on the docking station dashboard  130  and on the handheld  200  provide for alarm suspend/silence and mode/enter. The trim knob  140  is the primary method to toggle thru screen menus on the dashboard  130 . The procedure includes next, up, down or across page navigation, parameter selection and entry, data entry, alarm limit selection and selection of probe-off detection sensitivity. As a secondary control method, the modular patient monitor  100  has a port for an external keyboard for patient context entry and to navigate the menu. In an embodiment, the docking station  150  has a touch screen. In an embodiment, the modular patient monitor  100  has a bar code scanner module adapted to automatically enter patient context data. 
     The modular patient monitor  100  includes an integral handle for ease of carrying and dead space for storage for items such as sensors, reusable cables, ICI cable and cuff, EtCO 2  hardware and tubing, temperature disposables, acoustic respiratory sensors, power cords and other accessories such as ECG leads, BP cuffs, temperature probes and respiration tapes to name a few. The monitor  100  can operate on AC power or battery power. The modular patient monitor  100  stands upright on a flat surface and allows for flexible mounting such as to an anesthesia machine, bedside table and computer on wheels. 
       FIGS. 2A-B  illustrate a handheld monitor  200 , which provides pulse oximetry parameters including oxygen saturation (SpO 2 ), pulse rate (PR), perfusion index (PI), signal quality (SiQ) and a pulse waveform (pleth), among others. In an embodiment, the handheld  200  also provides measurements of other blood constituent parameters that can be derived from a multiple wavelength optical sensor, such as carboxyhemoglobin (HbCO) and methemoglobin (HbMet). The handheld  200  has a color display  210 , user interface buttons  220 , an optical sensor port  230  and speaker  240 . The handheld  200  also has external I/O such as a bar code reader and bedside printer connectivity. The handheld  200  also has a flexible architecture, power and memory headroom to display additional parameters, such as Sp v O 2 , blood glucose, lactate to name a few, derived from other noninvasive sensors such as acoustic, fetal oximetry, blood pressure and ECG sensors to name a few. In an embodiment, the handheld unit  200  has an active matrix (TFT) color display  210 , an optional wireless module, an optional interactive touch-screen with on-screen keyboard and a high quality audio system. In another embodiment, the handheld  200  is a Radical or Radical-7™ available from Masimo Corporation, Irvine Calif., which provides Masimo SET® and Masimo Rainbow™ parameters. A color LCD screen handheld user interface is described in U.S. Provisional Patent Application No. 60/846,472 titled Patient Monitor User Interface, filed Sep. 22, 2006 and U.S. Pat. No.  —   —   —   —   — _ titled Patient Monitor User Interface, filed Sep. 24, 2007, both applications incorporated by reference herein. 
       FIG. 3  illustrates a modular patient monitor color display  300 . The modular patient monitor display  300  auto-scales its presentation of parameter information based upon the parameters that are active. Fewer parameters result in the display  300  of larger digits and more waveform cycles. In an embodiment, the display  300  has a main menu screen showing date and time  302 , patient data  304 , battery life and alarm indicators  306  and all enabled parameters  308 . Date and time  302  can be enabled or disabled. The display  300  may also have dynamic bar graphs or indicators to show perfusion index and signal quality. Waveforms are displayed for SpO 2 , NIBP (non-invasive blood pressure), EtCO 2  (end-tidal carbon dioxide) and ECG (electrocardiogram) if enabled. Trend waveforms are displayed for parameters that are less dynamic, such as HbCO and HbMet. Further, the display  300  has individual text displays for alarms, alarm suspend, sensor off or no sensor, battery condition, sensitivity, trauma mode, AC power, printer function, recording function, connectivity messages and menus to name a few. Pulse search is indicated by blinking dashes in the pulse and parameter displays. In an embodiment, the color display  300  is an 11.1″ LCD with allowance for the use of a 10.4″ LCD within the standard mechanical design for the 11.1″ display. The docking station  101  also supports any external VGA display. 
     An exemplar color print illustration of the color display  300  is disclosed in U.S. Provisional Application No. 60/846,471 entitled Modular Patient Monitor, cited above. In particular, each of the displayed parameters are variously presented in one of a off-white to white shade, lime green to green shade, crimson to red shade, generally turquoise shade, generally chartreuse shade, yellow to gold shade, generally blue and generally purple shade, to name a few. 
       FIG. 4  illustrates a modular patient monitor  100  having a vertical orientation  401  and a horizontal orientation  403 . In the vertical orientation  401 , the display  300  presents data in a vertical format, such as shown in  FIG. 3 , above. In the horizontal orientation  403 , the display  300  presents data in a horizontal format, so that the data appears upright with respect to the viewer. That is, the display  300  automatically switches format according to the patient monitor  100  orientation. A patient monitor having a rotatable display format is described in U.S. Pat. No. 6,770,028 entitled Dual Mode Pulse Oximeter and incorporated by reference herein. 
       FIGS. 5A-C  illustrate an expansion module  500 , which the docking station  101  ( FIGS. 1A-E ) accepts for additional parameters and technologies, such as ICI-NIBP, glucose monitoring, ECG, EtCO 2 , conscious sedation monitoring, cerebral oximetry, anesthetic agent monitoring, lactate, patient body temperature and assay cartridges, to name a few. The expansion module  500  has an indicator  510  indicating parameters to be provided. In one embodiment, the expansion module  500  provides two parameters to the docking station, which is adapted to accept two modules  500  for four additional parameters. In an embodiment, an ECG module is used to provide an R-wave trigger for ICI-NIBP. 
     As shown in  FIGS. 1A-E , the modular patient monitor  100  includes various connectivity ports  170  such as Ethernet, USB, RS-232, RS-423, nurse call, external VGA and I/O ports for a keyboard and a bar code reader to name a few. As an option, the modular patient monitor  100  has on-board and bedside recorder capability. The modular patient monitor  100  also supports multiple wireless and hardwired communication platforms, web server technology that allows remote viewing of data as well as limited bi-directional control of module functionality and an optional wireless connectivity standards base technology, such as IEEE 802.11x. The wireless option is provided in the handheld  200  and the docking station  101 . A wireless module supports the downloading and temporary storage of upgrade software from a remote central server to a destination docking station or a specific module. In an embodiment, the modular patient monitor  100  supports patient context management, specifically the ability to upload or alternatively enter patient unique identification. The modular patient monitor  100  also connects both wired and wirelessly to other patient monitors. 
     The modular patient monitor  100  may be logged onto via the Internet so as to download raw waveforms and stored trending data for both customer service purposes and for data mining to enhance algorithms and so as to be uploaded with firmware updates. The modular patient monitor  100  may also incorporate removable storage media for the same purpose. In an embodiment, removable storage media functions as a black box, which is a diagnostic tool to retrieve device use information. In particular, the black box can record values displayed, raw waveforms including sounds, and buttons touched by the end user. A patient monitor with removable storage media is described in U.S. patent Ser. No. 10/983,048 entitled Pulse Oximetry Data Capture System filed Nov. 5, 2004 and incorporated by reference herein. 
     The modular patient monitor  100  may also have an audio module slot (not shown) accommodating an external audio system and wireless headphone module. In an embodiment, the docking station  101  audio system is configured to reproduce respiratory sounds from an ARR (acoustic respiratory rate) sensor. 
     In an embodiment, the modular patient monitor  100  has a redundant speaker system for alarms. The modular patient monitor  100  may also include alarms for all parameters and a parameter fusion alarm that involves analysis of multiple parameters in parallel. A user can select custom default alarm parameters for adult, pediatric and neonatal patients. A patient monitor having redundant alarm speakers is described in U.S. patent application Ser. No. 11/546,927 entitled Robust Alarm System, filed Oct. 12, 2006 and incorporated by reference herein. 
     An alarm condition exists for low battery, sensor-off patient, defective sensor, ambient light, parameter limit exceeded and defective speakers, as examples. Audible alarm volume is adjustable and when muted, a visual indicator is illuminated. In an embodiment, the volume is adjustable in at least of four discrete steps. The parameter display flashes to indicate which values are exceeding alarm limits, the parameter is enlarged automatically, and numerics are displayed in either RED or with a RED background. The audible alarm is silence-able with a default alarm silence period for up to two minutes. This delay can be user configurable. Separate from sleep mode, the audible alarms are permanently mutable via a password-protected sub-menu. The visual alarm indicator still flashes to indicate an alarm condition. A visual indicator on the dashboard indicates an alarm silence condition, such as blinking for temporary silence and solid for muted. An alarm speaker is mounted so as not to be susceptible to muffling from a bed surface, attached external monitor surface or other type of flat resting surface. Redundant and smart alarm annunciation is also provided. 
     The user accesses the setup menu via a front dashboard knob  140  and mode/enter button  150 . TABLE 1 shows user settable parameters. The user can override default settings on a patient-by-patient basis via setup menus. 
     
       
         
               
             
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 PARAMETER SETTINGS 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 SpO 2  high &amp; low limit 
               
               
                   
                 Pulse Rate high &amp; low limit 
               
               
                   
                 Pulse Tone volume 
               
               
                   
                 MetHb high and low limit 
               
               
                   
                 HbCO high &amp; low limit 
               
               
                   
                 ICI high and low limit 
               
               
                   
                 tHb high and low limit 
               
               
                   
                 EtCO 2  high and low limit 
               
               
                   
                 ARR high and low limit 
               
               
                   
                 Temp high and low limit 
               
               
                   
                 Glucose high and low limit 
               
               
                   
                 Audible alarm volume 
               
               
                   
                   
               
             
          
         
       
     
     Default settings are stored in non-volatile memory (NVM). There is a factory, hospital and user default setting which may be automatically based on patient recognition. The user can choose any of the three at any time. The user may over-write hospital and user default settings with their own preferences via a password protected “save as default” setup menu function. All parameters return to hospital default settings after a power cycle. 
     In one embodiment, the default settings are as shown in TABLE 2, stored in NVM. These settings are also over-written into NVM as a result of a factory reset or return to factory defaults function from within the setup menus. 
     
       
         
               
               
               
             
           
               
                   
                 TABLE 2 
               
               
                   
                   
               
               
                   
                 PARAMETER 
                 FACTORY DEFAULT 
               
               
                   
                   
               
             
             
               
                   
                 SpO2 high limit 
                 Off 
               
               
                   
                 SpO2 low limit 
                 90 
               
               
                   
                 Pulse Rate high limit 
                 140  
               
               
                   
                 Pulse Rate low limit 
                 40 
               
               
                   
                 Alarm Volume 
                 2 (of 4) 
               
               
                   
                 Pulse tone volume 
                 2 (of 4) 
               
               
                   
                 MetHb high limit 
                  5% 
               
               
                   
                 MetHb low limit 
                 Off 
               
               
                   
                 HbCO high limit 
                 10% 
               
               
                   
                 HbCO low limit 
                 Off 
               
               
                   
                 LCD brightness 
                 3 (of 5) 
               
               
                   
                   
               
             
          
         
       
     
       FIGS. 6A-E  illustrate another modular patient monitor  600  embodiment having a docking station  601 , a handheld monitor  602  and parameter cartridges  700 . Each cartridge  700  provides one parameter to the docking station  601 , which accepts four cartridges  700  for a total of four additional parameters. Further, the patient monitor  600  also has a cord management channel  630 , an oral temperature probe  660  and probe covers  670  located on the docking station  601 . The docking station  601  has a trim knob  652  and control buttons  654  on a front stand  653  so as to support system navigation and data entry. The docking station  601  also has a color display  605 , a thermal printer  620 , an alarm indicator light bar  651 , a thermal printer paper door  657  and a handle  659 , a sensor holder  655 , connectivity ports  680  and a power supply module  690 .  FIGS. 7A-C  illustrate a parameter cartridge  700  having an indicator  710  indicating the parameter or technology provided. 
       FIGS. 8A-D  illustrate a three-piece modular patient monitor  800  including a handheld monitor  810 , a shuttle station  830  and a docking station  850 . The docking station  850  has a shuttle port  855  that allows the shuttle station  830  to dock. The shuttle station  830  has a handheld port  835  that allows the handheld monitor  810  to dock. Accordingly, the modular patient monitor  800  has three-in-one functionality including a handheld  810 , a handheld  810  docked into a shuttle station  830  as a handheld/shuttle  840  and a handheld/shuttle  840  docked into a docking station  850 . When docked, the three modules of handheld  810 , shuttle  830  and docking station  850  function as one unit. 
     As shown in  FIGS. 8A-D , the handheld module  810  functions independently from the shuttle  830  and docking station  850  and is used as an ultra-light weight transport device with its own battery power. The handheld  810  docked into the shuttle module  830  functions independently of the docking station  850  and expands the handheld parameter capability to the ability to measure all parameters available. The docking station  850 , in turn, provides the shuttle  830  or handheld/shuttle  840  with connectivity ports  852 , a power supply module  854 , a large color display  856 , wireless and hardwired communications platforms, a web server and an optional printer. As such, the docking station  850  charges the handheld  810  and shuttle  830 , provides a larger screen and controls, such as a trim knob, allows wireless, hardwired and Internet communications and provides connectivity to various external devices.  FIG. 8E  illustrates another modular patient monitor embodiment  805  having a shuttle  870  with plug-in modules  860  for expanded parameter functionality. 
     In an embodiment, the handheld monitor  810  incorporates blood parameter measurement technologies including HbCO, HbMet, SpO 2  and Hbt, and the shuttle station  830  incorporates non-blood parameters, such as intelligent cuff inflation (ICI), end-tidal CO 2  (EtCO 2 ), acoustic respiration rate (ARR), patient body temperature (Temp) and ECG, to name a few. In an alternative embodiment, parameters such as SpO 2 , ARR and ECG that clinicians need during in-house transports or patient ambulation are loaded into the handheld  810 . 
       FIG. 9  illustrates a two-piece modular patient monitor  900  having a shuttle  930  and a docking station  950  without a corresponding handheld. In an embodiment, the shuttle  930  has plug-in modules  960  for added parameter functions. 
       FIGS. 10A-C  illustrate yet another modular patient monitor  1000  embodiment having dual removable handhelds  1010  and a docking station  1050  without a corresponding shuttle. For example, the handhelds  1010  may include one blood parameter monitor and one non-blood parameter monitor. 
       FIGS. 11A-C  illustrate a handheld tablet monitor  1100  having a display  1110 , a trim knob  1120  and control buttons  1130 . An electroluminescent lamp  1140  on the front panel provides a thin uniform lighting with low power consumption. A temperature probe  1150  is attached to the monitor  1100 . The tablet monitor  1100  connects to a multiple parameter sensor through a patient cable  1160 .  FIGS. 12-13  illustrate a handheld monitor  1200  configured to plug into a compact holder/battery charger  1300 . The handheld monitor  1200  is adapted to plug into the compact charger  1300 . 
       FIG. 14  illustrates a modular patient monitor  1400  embodiment having various handheld monitors  1410 , a docking station adapter  1430  and a legacy docking station  1450 . The handheld monitors  1410  can include legacy handhelds  1411  and upgrade handhelds  1412 . The docking station adapter  1430  is configured for the legacy docking station  1450  so that both legacy handhelds  1411  and upgrade handhelds  1412  can dock into the legacy docking station  1450  directly or via the docking station adapter  1430 . 
       FIGS. 15A-B  illustrate a “notebook” modular patient monitor  1500  embodiment having a foldable lid  1510 , a fixed body  1530  and a foldable docking station  1550 . The fixed body  1530  houses patient monitor electronics and provides external device connectivity at a back end (not visible). The lid  1510  has a notebook display  1551 , such as a color LCD. The docking station  1550  has a port  1551  that removably connects, both mechanically and electrically, a corresponding handheld monitor  1590 , such as the handheld embodiments described above. In a closed position ( FIG. 15A ), the notebook monitor  1500  can be carried via an optional handle or simply in hand or under an arm. In an open position ( FIG. 15B ), the notebook monitor is operational, connecting to patient sensors via the handheld  1590  or a sensor connector (not shown) on the back end of the notebook. In the open position, the docking station  1550  can stay in a stowed or folded position (not shown) so that the handheld screen  1591  faces upward. Alternatively, in the open position, the docking station  1550  is unfolded as shown ( FIG. 15B ) so that the handheld display  1591  can be easily viewed from the front of the notebook in conjunction with the notebook display  1511  in the lid  1510 . In an embodiment, the notebook  1500  can have a conventional keyboard and touch pad, have conventional monitor controls, incorporate a conventional computer and peripherals or a combination of the above. As shown, the notebook display  1511  faces inward, so that the display  1511  is protected in the folded position. In another embodiment, the display  1511  faces outward (not shown). 
       FIG. 16  illustrates a flat panel modular patient monitor embodiment  1600  having a flat panel body  1610  housing a flat panel display  1611  and a handheld port  1620 . The handheld port  1620  removably accepts a handheld monitor  1690  having a handheld display  1691 , such as the handheld monitors described above. The flat panel monitor  1600  can be free-standing on a table top, wall-mounted or mounted on or integrated within a patient bed, as a few examples. The flat panel monitor  1600  can be simply a docking and display device or can provide built-in patient monitoring functions and parameters not available to the handheld  1690 . 
     A modular patient monitor has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of the claims that follow. One of ordinary skill in art will appreciate many variations and modifications.

Technology Category: 1