Modular patient monitor

[0001] 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.

[0002] 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 (SpO₂), as a pulse rate (PR) and as a pulse waveform (plethysmograph or “pleth”).

[0003] 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.

[0004] Expansion modules provide blood pressure BP, blood glucose, ECG, CO₂, 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.

[0005] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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, EtCO₂ 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.

[0027] FIGS. 2A-B illustrate a handheld monitor 200, which provides pulse oximetry parameters including oxygen saturation (SpO₂), 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_vO₂, 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.

[0028] 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 SpO₂, NIBP (non-invasive blood pressure), EtCO₂ (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.

[0029] 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.

[0030] 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.

[0031] 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, EtCO₂, 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038]

TABLE 1
PARAMETER SETTINGS
	SpO2 high & low limit
	Pulse Rate high & low limit
	Pulse Tone volume
	MetHb high and low limit
	HbCO high & low limit
	ICI high and low limit
	tHb high and low limit
	EtCO2 high and low limit
	ARR high and low limit
	Temp high and low limit
	Glucose high and low limit
	Audible alarm volume

[0039] 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.

[0040] 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.

[0041]

	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)

[0042] 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.

[0043] 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.

[0044] 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.

[0045] In an embodiment, the handheld monitor 810 incorporates blood parameter measurement technologies including HbCO, HbMet, SpO₂ and Hbt, and the shuttle station 830 incorporates non-blood parameters, such as intelligent cuff inflation (ICI), end-tidal CO₂ (EtCO₂), acoustic respiration rate (ARR), patient body temperature (Temp) and ECG, to name a few. In an alternative embodiment, parameters such as SpO₂, ARR and ECG that clinicians need during in-house transports or patient ambulation are loaded into the handheld 810.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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).

[0051] 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.

[0052] 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.