US20140318542A1 - Patient monitoring and drug delivery system and method of use - Google Patents

Abstract

Disclosed is a patient monitoring and drug delivery system and associated methods for use during diagnostic, surgical or other medical procedures. The functionality of the invention enables many time consuming and laborious activities to be minimized or moved to a part in the procedure where time is not as critical. The invention is capable of increasing practice efficiency in patient care facilities through system architecture and design into two separate units. A patient unit receives input signals from patient monitoring connections and outputs the signals to a procedure unit. The procedure unit is operational during the medical procedure and controls the delivery of drugs to the patient.

Description

CROSS REFERENCE To RELATED APPLICATION
• This application is a continuation of U.S. application Ser. No. 12/911,788 filed on Oct. 26, 2010, presently allowed, which is a continuation of U.S. patent application Ser. No. 10/791,959 filed on Mar. 3, 2004, issued as U.S. Pat. No. 7,833,213 on Nov. 16, 2010, and claims the benefit and priority from U.S. provisional application Ser. No. 60/451,860, filed on Mar. 4, 2003, the contents of which are incorporated by reference herein in its entirety.
FIELD OF THE INVENTION
• The present invention relates in general to patient monitoring and drug delivery systems, and more particularly, to methods and apparatus for providing increased practice efficiency throughout medical procedures.
BACKGROUND OF THE INVENTION
• Patient monitoring systems are typically used to monitor physiological parameters of patients undergoing diagnostic or surgical procedures. A variety of patient monitoring systems have been employed for the sole purpose of monitoring a patient under the influence of analgesic or amnestic drugs that are administered during painful or anxiety-causing procedures. A monitoring system capable of accurately and reliably monitoring a patient as well as being easy to use is desired.
• Unfortunately, known monitoring system suffer from several disadvantages. Monitoring systems in the related art fall generally into two categories: high end, multi-function monitors which collect a multitude of data and are typically used in the procedure, and smaller, limited function monitors which gather only basic physiological data that are typically used in pre-procedure and recovery areas. Inefficiencies occur when the patient must be disconnected from one monitoring system and then, once in the procedure room, connected to a more robust monitoring system that will provide additional critical information during a surgical procedure. The process of connecting and disconnecting multiple physiological data acquisition probes from the patient causes practice inefficiencies by adding time consuming activities, resulting in an overall lengthier medical or surgical procedure.
• A patient care system that increases practice efficiency is needed in many patient care facilities. A patient care facility desires to maximize efficiency and perform as many cases as safely possible in a given day. Many patient care facilities find the largest obstacle to increasing practice efficiency relates to minimizing the amount of clinician time that is required in the procedure room. The number of cases a doctor may perform in a given day is limited in part to the amount of time the patient is in the procedure room. The amount of time required to complete a particular procedure is somewhat fixed and based upon the skill and experience level of the clinician. However, much can be done to improve upon clinic practice pre-procedure and post procedure.
• Typically in a pre-procedure room, a nurse or technician prepares the patient for the upcoming procedure. This preparation may include connecting monitors to the patient for the purpose of obtaining baseline data to be used in the procedure. Monitors that are commonly used include blood pressure (systolic, diastolic, and mean arterial pressure), and pulse oximetry, which measures a patient's arterial oxygen saturation and heart rate typically via an infrared diffusion sensor. Blood pressure readings are generally taken by a blood pressure cuff A nurse or technician must secure the cuff around a patients arm and use a bulb type device to pump air into the cuff Once the reading from the cuff stabilizes, the nurse or technician must manually record the data, usually handwritten on a sheet of paper, and save this information for later reference during the procedure and eventually, for the patient report. For the nurse or technician to take a pulse oximeter reading, he or she must boot up the pulse oximeter module, secure a pulse oximeter probe upon the patient and take a reading of the patient. This reading is also written down on paper to be saved for later use. Once it is determined the patient is ready for the procedure, the nurse or technician must disengage the blood pressure cuff and pulse oximetry probes from the patient, so the patient can be transported from the pre-procedure room to the procedure room.
• After the patient enters the procedure room and before the procedure may begin, several tasks are needed to prepare the patient for the procedure. The nurse or technician must reconnect both blood pressure and, pulse oximetry before the procedure can begin. In addition to blood pressure and pulse oximetry other connections such as, for example, capnography, supplemental oxygen, and electrocardiogram are required. A great deal of time is required to connect the physiological monitors to the patient and to connect the physiological monitors to the monitoring system. The nurse or technician must spend time reconnecting physiological monitors that were connected to the patient in the pre-procedure room. The time it takes to make these connections occupies valuable procedure room time, thus decreasing practice efficiency. Clearly a need exists to minimize or eliminate these monitor connections and reconnections while their patient is in the procedure room.
• Besides the time delays which may be encountered when adding sensors to the monitors, monitoring systems in the prior art leave much to be desired with respect to cable management. A large number of cables extend between the patient and the monitor. In the past there has been at least one cable for every parameter monitored. This array of cables and hoses interferes with the movement of personnel around the patient's bed. The greater the number of cables and hoses, the greater the risk that someone will accidentally disrupt one of them. In the course of a procedure, many people including nurses, technicians, and physicians must be able to move around the room and access the patient without, having to navigate around cables. This invention addresses cable management, by minimizing the number of cables between patient and monitor.
• An additional focus of this invention is the use of fast acting analgesic or amnestic drugs to decrease the length of most procedures and the time needed to recover from procedures, thus increasing practice efficiency. Current solutions for providing patient relief from pain and anxiety require the use of drugs that require a relatively long time to take peak effect and, take a relatively long time for the effect to pass from patient. Physicians must wait for drugs to take full effect for the procedure to begin. The time spent waiting for the drug to take affect is wasted time that hinders practice efficiency. This invention provides means for safely and reliably delivering fast acting drugs in an effort to increase practice efficiency.
• An additional focus of this invention is to automate several functions currently performed by clinicians to increase practice efficiency. In current practice, prior to IV drug delivery, nurses must manually purge the IV line of any air that may be trapped in the line before connecting the line to a patient. Failure to do so will result in harmful effect on the patient from air entering the patient's blood stream. The process of purging this line takes a significant amount of time and hinders practice efficiency. This invention provides means for automating the line purging process.
DESCRIPTION OF THE DRAWING
• Other objects and many of the intended advantages of the invention will be readily appreciated as they become better understood by reference to the following detailed description of embodiments of the invention considered in connection with the accompanying drawings, wherein:
• FIG. 1 is a perspective view of a one embodiment of a care system apparatus constructed in accordance with this invention, depicting a bedside or patient unit and a procedure unit.
• FIG. 2 is a perspective view of an embodiment of a care system apparatus constructed in accordance with this invention depicting a mobile patient unit.
• FIG. 3 is a perspective view of an embodiment of a care system apparatus constructed in accordance with this invention depicting the patient unit connected with various patient sensors, and other patient interfaces.
• FIG. 3-A is a perspective view of an alternate embodiment of a patient unit.
• FIG. 3-B is a perspective view of the patient unit ofFIG. 3-A connected to a procedure unit.
• FIG. 3-C is an exploded view of the patient unit ofFIG. 3-A.
• FIG. 3-D is a perspective view of the patient unit ofFIG. 3-A illustrating the cable connection and bedside connection.
• FIG. 3-E is exploded view of an alternate embodiment of the the patient unit ofFIG. 3-A.
• FIG. 4 is a perspective view of the procedure unit.
• FIG. 4-A is a flow diagram depicting the auto priming aspect of the invention.
• FIG. 4-B is a partial cut-away view of a drug cassette for use with the procedure unit.
• FIG. 4-C is a perspective view of an alternate embodiment of a drug cassette and pump module for use with the procedure unit.
• FIG. 5 is a cross-sectional view of the communication cable.
• FIG. 6 is a block diagram overview of the invention.
• FIG. 7 is an overview data-flow diagram depicting the pre-medical procedure aspect of the invention.
• FIG. 8 is an overview data-flow diagram depicting the medical procedure aspect of the invention.
• FIG. 9 is an overview data-flow diagram depicting the post-medical procedure aspect of the invention.
SUMMARY OF THE INVENTION
• The invention provides apparatuses and methods to efficiently deliver a pharmaceutical drug, for example and not limited to, a sedative, analgesic or amnestic drug, to a patient during a medical procedure as exemplarily described in U.S. patent publications US2002/0017296, US2002/0017300 and US2002/0188259.
• The functionality of the invention allows for, but is not limited to, enabling many time consuming and laborious activities to be minimized or moved to a part in the procedure where time is not as critical. To these ends, the invention is capable of physically separating through system architecture and design into two separate monitoring units which, when used as described herein, will increase practice efficiency in patient care facilities.
• In general, the invention is a micro-processor based patient monitoring system and drug delivery system having a patient unit that receives input signals from patient monitoring connections. The patient unit outputs patient parameters to a procedure unit and also includes a display screen for displaying patient parameters. The procedure unit is operational during the medical procedure and receives patient parameters from the patient unit. The procedure unit controls the delivery of drugs to the patient.
• An additional aspect of this invention is directed to the facilitation of creating a patient record of the procedure. Current techniques for creating a patient record involve manual note taking by a nurse during the course of a patients stay. This technique is time consuming and may lead to errors in record keeping. This invention provides mean for monitoring patient parameters throughout a procedure, electronically capturing data and giving the nurse or technician the option of printing a copy of this data for the purpose of record keeping.
• A further aspect of this invention is a method for monitoring a patient and delivering at least one drug during a medical procedure that comprises the steps of connecting to the patient at least one sensor for monitoring at least one physiological parameter of the patient; providing a microprocessor-based patient unit having at least one first connection point and receiving input signals from the at least one sensor through the at least one first connection point and at least one second connection point for outputting patient physiological parameters; inputting to the patient unit physical attributes of the patient; and creating a patient record.
• A further expression of the method for monitoring a patient and delivering at least one drug during a medical procedure includes connecting the at least one second connection point to a micro processor-based procedure unit; connecting a drug cassette containing a drug vial to an infusion pump; delivering the drug to the patient and performing a medical procedure; and disconnecting the at least one second connection point from the procedure unit.
• A still further expression of the method includes monitoring the at least one physiological condition of the patient; disconnecting the input signals from the at least one sensor from the at least one first connection point; and terminating the creation of the patient record.
• Other focuses of the invention are apparent from the below detailed description of preferred embodiments.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention.
• It is further understood that any one or more of the following-described embodiments, expressions of embodiments, examples, methods, etc. can be combined with any one or more of the other following-described embodiments, expressions of embodiments, examples, methods, etc.
• The system block diagram ofFIG. 6 depicts the system architecture of one embodiment of the invention. This diagram illustrates the relationships between the components of a patient care system5, which are described in more detail below.Procedure unit12 has several integrated components includingECG module36, cannula module38, battery82 andperistaltic infusion pump72.External oxygen16 and external power78 are not integrated intoprocedure unit12 however; they do have connections toprocedure unit12.Peristaltic infusion pump72 interfaces withdrug cassette64 to pump analgesic or sedative drugs. These analgesic or sedative drugs are then pumped throughIV tubing76 and into the patient. In addition to the displays incorporated intobedside unit10 andprocedure unit12, anoptional display20 is available for use by the clinician, and could display information such as, for example, patient physiological parameters and, warning alarms.Procedure unit12 may use a wireless transmitter device such as, for example, “Blue Tooth” to send signals to a wireless receiver device located onoptional display20.Communication cable14 serves as a data link betweenprocedure unit12 andbedside unit10.Bedside unit10 has a plurality of integrated devices including,NIBP module34,pulse oximeter module26,ART modules30,32, andbedside unit battery24.Bedside unit10 allows for several connections betweenbedside unit10 and the patient being monitored including but not limited to oralnasal cannula48,ECG pads50,NIBP cuff58,pulse oximeter probe60, ART earpiece55, andART handpiece57.Bedside unit10 is designed to function independent of, or connected toprocedure unit12.
• As shown inFIG. 1, patient care system5 comprises two monitoring units; abedside unit10 and aprocedure unit12. One exemplary use of patient care system5 is to monitor patient parameters and deliver sedative, analgesic and/or amnestic drugs to a conscious, non-intubated, spontaneously-ventilating patient undergoing a diagnostic or surgical procedure by a physician. This use is not exhaustive of all of the potential uses of the invention but will be used to describe the invention.
• Bedside unit10 andprocedure unit12 are connected viacommunication cable14.Communication cable14 provides means for transmitting electronic data as well as various hydraulic signals and gases between besideunit10 andprocedure unit12.Communication cable14 may be removed from bothbedside unit10 andprocedure unit12 to facilitate practice efficiency and user convenience.Bedside unit10 andprocedure unit12 are free to move independently of each other ifcommunication cable14 is not in place. This allows for mobility of each unit independent of the other; this feature is especially important in hospitals that have a great deal of medical procedures and there is little time to connect patients to monitors.Bedside unit10 andprocedure unit12 preferably accommodate an external oxygen source that is intended to provide supplemental oxygen to the patient during the course of a surgical procedure if the clinician so desires. An IV tube set76 is shown connected toprocedure unit12 and delivers sedative or amnestic drugs to a patient during a surgical procedure.
• As shown inFIG. 2, besideunit10 is compact and portable so it requires little effort to move from one room to another. In the one embodiment,bedside unit10 could mount upon either an IV pole or a bedrail; this would free the clinician from the burden of carrying the unit wherever the patient needs to be transported.Bedside unit10 is small and light enough to be held in the hand of a nurse or technician.Bedside unit10 allows the user to input information via the bedside touch screen assembly or a simple keypad22. Bedside touch screen assembly22 is a display device that is integrated into one surface ofbedside unit10, and displays patient and system parameters, and operational status of the apparatus. An exemplary bedside touch screen assembly22 is a 5.25″ resistive touch screen manufactured by MicroTech mounted upon a 5.25″ color LCD manufactured by Samsung. An attending nurse or physician may enter patient information such as, for example, patient weight and a drug dose profile intobedside unit10 by means of bedside touch screen assembly22.Bedside unit battery24 is fixedly attached to thebedside unit10 and is a standard rechargeable battery such as, for example, Panasonic model no. LC-T122PU, that is capable of supplying sufficient power to runbedside unit10 for an extended period of time. In one embodiment,bedside unit battery24 can be recharged whilebedside unit10 is connected toprocedure unit12 viacommunication cable14 or can be charged directly from an independent power source.
• As shown inFIG. 3bedside unit10 may be connected to a plurality of patient sensors and peripherals used to monitor patient vital signs and deliver supplemental oxygen to the patient. One aspect of the invention integrates drug delivery with one or more basic patient monitoring systems. These systems interface with the patient and obtain electronic feedback information regarding the patient's physiological condition. Oralnasal cannula48 delivers oxygen from an external oxygen source and collects samples of exhaled gas. Oralnasal cannula48 is removably attached to cable pass-throughconnection15. Cable pass-throughconnection15 sends the signal obtained by oralnasal cannula48 directly to a capnometer (e.g., a CardioPulmonary Technologies CO2WFA OEM) inprocedure unit12 and preferably via communication cable14 (FIG. 1). The capnometer measures the carbon dioxide levels in a patient's inhalation/exhalation stream via a carbon dioxide-sensor as well as measuring respiration rate. Also attached to the cable pass-throughconnection15 is a standard electrocardiogram (ECG)50, which monitors the electrical activity in a patient's cardiac cycle. The ECG signals are sent to theprocedure unit12 where the signals are processed.
• Also connect tobedside unit10 is a pulse oximeter probe60 (e.g., Dolphin Medical) and a non-invasive blood pressure (NIBP)cuff58.Pulse oximeter probe60 measures a patient's arterial saturation and heart rate via an infrared diffusion sensor. The data retrieved bypulse oximeter probe60 is relayed to pulse oximeter module26 (e.g., Dolphin Medical) by means ofPulse Oximeter Cable61. The non-invasive blood pressure (NIBP) cuff58 (e.g., a SunTech Medical Instruments PN 92-0011-00) measures a patient's systolic, diastolic and mean arterial blood pressure by means of an inflatable cuff and air pump (e.g., SunTech Medical), also incorporated as needed.NIBP cuff58 is removably attached toNIBP module34 located onbedside unit10.
• A patient's level of consciousness is detected by means of an Automated Response Tester System (ART). An exemplary ART system is disclosed in U.S. patent application Ser. No. 10/674,160 and filed on Sep. 29, 2003, which is incorporated by reference herein. The ART system comprises a query initiate device and a query response device. The ART system operates by obtaining the patient's attention with the query initiate device and commanding the patient to activate the query response device. The query initiate device may be any type of stimulus such as a speaker via an earpiece55, which provides an auditory command to a patient to activate the query response device. The query response device is ahandpiece57 that can take the form of, for example, a toggle or rocker switch or a depressible button or other moveable member hand held or otherwise accessible to the patient so that the member can be moved or depressed by the patient upon the patient's receiving the auditory or other instruction to respond. Alternatively, a vibrating mechanism may be incorporated into thehandpiece57 that cues the patient to activate the query response device. In one embodiment, the query initiate device is a cylindricalhandheld device57, containing a small 12V dc bi-directional motor enabling the handheld device to vibrate the patient's hand to solicit a response.
• After the query is initiated, the ART system generates signals to reflect the amount of time it took for the patient to activate the query response device in response to the query initiate device. These signals are processed by the main logic board located insidebedside unit10 and are displayed upon either bedside touch screen assembly22, procedure touch screen assembly62 (FIG. 4) or an optional monitor20 (FIG. 6). The amount of time needed for the patient to respond to the query gives the clinician an idea as to the sedation level of the patient. The ART System has two modules, thequery response module32 and the query initiatemodule30, collectively referred to as theART system modules30,32.ART system modules30,32 have all the necessary hardware to operate and connect thequery response device57 and the query initiate device55 tobedside unit10.
• In oneembodiment monitoring modules26,30,32, and34 are easily replaceable with other monitoring modules in the event of malfunction or technological advancement. These modules include all the necessary hardware to operate their respective peripherals. The above-mentioned patient modules are connected to a microprocessor-based electronic controller or computer (sometimes also referred to herein as main logic board, MLB) located within each of theprocedure unit12 andbedside unit10. The electronic controller or main logic board comprises a combination of available programmable-type microprocessors and other “chips,” memory devices and logic devices on various board(s) such as, for example, those manufactured by Texas Instruments (e.g., XK21E) and National Semiconductor (e.g., HKL72), among others.
• Oncebedside unit10 andprocedure unit12 are connected viacommunication cable14, ECG and capnography will be monitored, and supplemental oxygen will be delivered to the patient. Preferably, however, these connections are made in the pre-procedure room to increase practice efficiency. By making these connections in the pre-procedure room, less time is required in the procedure room connecting capnography, ECG and supplemental oxygen toprocedure unit12. Oralnasal cannula48 and ECG leads51 are connected directly to cable pass-throughconnection15. Cable pass-throughconnection15, located onbedside unit10, is essentially an extension ofcommunication cable14, which allows the signals from ECG leads51 and oralnasal cannula48 to bypassbedside unit10 and be transferred directly toprocedure unit12. It will be evident to those skilled in the art, however, that thebedside unit10 could be configured to accept theECG50 and oral/nasal cannula48 signals and process the signals accordingly to provide the information on screen22 and supplemental oxygen to the patient in the pre-procedure room. As more features are added to thebedside unit10, however, the portability may be limited.
• Referring now toFIG. 3-A there is shown aconsole assembly410 of the present invention in connection withprocedure unit12. In this embodiment, console assembly is a simpler version of thebedside unit10. As used herein, the term “proximal” refers to a location on theconsole assembly410 closest to the device using theconsole assembly410 and thus furthest from the patient connected to theconsole assembly410. The term “distal” refers to a location farthest from the device using theconsole assembly410 and closest to the patient.
• As illustrated inFIGS. 3A-D,console assembly410 comprises mounting412,console box420, andconsole connector cable450. Mounting412 allowsconsole assembly410 to easily mount horizontally or vertically on, for example a patient's bed rail or IV pole, and is preferably made of a rigid thermoplastic such as, for example, polycarbonate. Mounting412 is attached to the proximal end ofConsole Box420 and includes mountingposts414 thereon. Mountingposts414 help secure mounting412 on a patient's bed rail or IV pole.
• Console box420, with an outer casing preferably made of a rigid thermoplastic such as, for example, polycarbonate, includesfaceplate419 andhub421.Faceplate419 can be fixedly attached tohub421 using any attachment means including, but not limited to, glue, mechanical fasteners, screws, and ultrasonic welding.Console box420 further includesreceptacles432 therein.Receptacles432 include, but are not limited to,pulse oximeter port434,ECG monitor port436, NIBP monitorport438,ART earpiece jack440,ART handpiece port442, and oralnasal cannula port444 that includes supplemental oxygen delivery.Receptacles432 can be standard medical device connections, well known in the medical art, or custom device connections for use with medical devices custom designed to connect toconsole box420.Console box420 further includes a plurality of electrical wires422, air lines424 and oxygen delivery tubes426 therein which connect from therespective receptacle432 throughconsole box420 and to corresponding wires452, tubes454 and power lines456 inconnector cable450.
• As shown inFIG. 3-A,Console assembly410 further includes a plurality ofcables430.Cables430, which connect toreceptacles432, attach to any number of devices during a surgical procedure to monitor a patient, among other things. These devices can include, but are not limited to, an oral nasal cannula, a blood pressure cuff, ECG leads and a pulse oximeter monitor, among others.
• Connector cable450, which is covered with insulation, such as, for example mil-ene or silicon, includes a plurality of wires452, tubes454 and power lines456 that supply electrical signals, hydraulic signals, and oxygen delivery integrated into one cable and allowconsole box420 to be hardwired toprocedure unit12.Connector cable450 further includesstrain relief451 at its distal end. Strain reliefs are well known in the art and play an important role in helping to prevent flexing, which causes wires to break after prolonged use, at the connection betweenconnector cable450 andconsole box420.
• As shown inFIG. 3-E,Console box420 further includescircuit board459,microprocessor460, removableflash memory reader461,removable flash memory462,battery464, and at least onecomputer interface466.Circuit board459 can be a multi-layered printed circuit board. Copper circuit paths called traces that resemble a complicated roadmap carry signals and voltages acrosscircuit board459. Layered fabrication techniques can be used so that some layers ofcircuit board459 can carry data formicroprocessor460 andremovable flash memory462 while other layers carry voltages and ground returns without the paths short-circuiting at intersections. The insulated layers can be manufactured into one complete, complex sandwich. Chips and sockets can be soldered ontocircuit board459. Mounted tocircuit board459 ismicroprocessor460.Microprocessor460 is the computational engine of the data received byconsole box420 from the external monitors. Microprocessors are well known in the computer field and one of many suitable microprocessors such as, for example, a Pentium, a K6, a PowerPC, a Sparc, a Motorola Dragonball™, among others, may be used formicroprocessor460.Microprocessor460 can be run by a software application. The software application can be written in one of many formal programming languages, which can include, but is not limited to Java, C++, Visual Basic, and Fortran. The software application andmicroprocessor460 together create a data log of all the physiological parameters gathered from the patient viaconsole box420 andprocedure unit12.Circuit board459 also has removableflash memory reader461 electrically attached thereto. Removableflash memory reader461, which includes a slot in the outer casing ofconsole box420, more specificallyhub421, allowsremovable flash memory462 to be inserted and removed fromcircuit board459. Whenremovable flash memory462 is inserted in removableflash memory reader461,removable flash memory462 is in digital communication withmicroprocessor460,circuit board459, andcomputer interface466.Removable flash memory462 is a solid-state storage device used for easy and fast information storage of the data log generated bymicroprocessor460 running its corresponding software application.Removable flash memory462 is well known in the computer field and one of the many suitable flash memory cards such as, for example, a SmartMedia Card, a MultiMedia Card, or a CompactFlash Card along with others may be used forremovable flash memory462. The data is stored so that it may be retrieved fromremovable flash memory462 at a later time.
• Whenconsole assembly410 is removed fromprocedure unit12 or another external monitor,battery464, which can be comprise lithium ion, supplies power to the components inconsole box420 includingmicroprocessor460.Microprocessor460 along with its software application andremovable flash memory462 can digitally communicate its data throughcomputer interface466.Computer interface466 can include, but is not limited to, a standard serial port, a USB port, an IEEE1394 port, a RS232 port, or an Ethernet port.Computer interface466 sends data formatted by the software application to be printed as a patient report. In addition,removable flash memory462 can be removed fromconsole box420 and inserted in one of many compatible flash memory card readers so that the data may be downloaded on a personal computer or handheld device.
• During a surgical procedure usingconsole assembly410 of the present invention, the patient is first admitted and prepped for the procedure. During this stage, a health care clinician or surgeon connects various vital monitors such as, for example, a pulse oximeter monitor on the patient.Cables430 associated with these monitors are connected to therespective receptacle432 onconsole box420. A patient record is then initiated throughmicroprocessor460 and its software application inflash memory462 and data from the patient such as vitals fromcables430 can now be stored inflash memory462. Next, the patient is moved to the procedure room andconsole assembly410 connects toprocedure unit12 or other medical monitoring devices.Flash memory462 continues to collect data for the patient record gathering information viamicroprocessor460 fromcable430 andprocedure unit12 including, but not limited to, vital signs, drugs delivered, and other physiological parameters. After the procedure iscomplete console box420 is disconnected fromprocedure unit12, and the patient is moved to a recovery and discharge stage. During this stage,flash memory462 continues to gather data fromcable430 including, but not limited to vitals and post-op drugs. When the patient is ready for discharge,flash memory462 stops taking data and closes the patient record.
• Referring now toFIG. 4,procedure unit12 allows a physician to safely deliver drugs, such as a sedative or analgesic drug to a patient and monitor the patient during the medical procedure. Procedure touch screen assembly62 is a display device that is integrated into the surface ofprocedure unit12, which displays patient and system parameters, and operation status of the apparatus. In one embodiment, procedure touch screen assembly62 consists of a 15″ resistive touch screen manufactured by MicroTech mounted upon a 15″ color LCD manufactured by Samsung. It should be noted that procedure touch screen assembly62 is the primary display and input means, and is significantly larger than the bedside touch screen assembly22 and capable of displaying more detailed information. In addition to procedure touch screen assembly62, the user may input information intoprocedure unit12 by means of drug delivery controls80. Drug delivery controls80, such as buttons or dials, are located on one side ofprocedure unit12 and preferably, allow the clinician to change various system parameters and bypass procedure touch screen assembly62.Printer70 is integrally attached to the top ofprocedure unit12.Printer70 allows the clinician to print a patient report that includes patient data for pre-op and the procedure itself The combination of printing a patient report and the automatic data logging features decrease the amount of time and effort a nurse or technician must spend regarding patient condition during the course of a procedure.Printer70 receives data signals from a printer interface (e.g., Parallel Systems CK205HS), which is located on the main logic board.Printer70 may be a thermal printer (e.g., Advanced Printing Systems (APS) ELM 205HS).
• Memory card reader85, which includes a slot in the outer casing ofprocedure unit12, allowsflash memory card84 to be inserted and removed fromprocedure unit12.Flash memory card84 is a solid-state storage device used for easy and fast information storage of the data log generated byprocedure unit12.Flash memory card84 is well known in the computer field and one of the many suitable removable flash memory cards as for example, a SmartMedia Card, a MultiMedia Card, or a CompactFlash Card, may be used with memory card reader85. The data is stored so that it may be retrieved fromflash memory card84 at a later time. In one embodiment, memory card reader85 acceptsflash memory card84 containing software to upgrade the functionality of patient care system5.Data port88 can include, but is not limited to, a standard serial port, a USB port, a RS232 port, or an Ethernet port.Data port88 is useful to linkprocedure unit12 to an external printer to print a patient report or to transfer electronic files to a personal computer or mainframe. In an alternate embodiment,data port88 can be a wireless transmitter interacting with a wireless receiver connected to a printer or an external computer or mainframe.
• Referring also toFIGS. 4-B and4-C,procedure unit12 delivers fluid to a patient via an infusion pump, such as a peristaltic infusion pump72 (e.g., B-Braun McGaw).Peristaltic infusion pump72 is integrally attached toprocedure unit12. A peristaltic infusion pump uses peristaltic fingers to create a wavelike motion to induce fluid flow inside a flexible tube connected to a fluid reservoir.Drug cassette64 is a generally rectangular shaped structure that is placed adjacent toperistaltic infusion pump72.Drug cassette64 is preferably made of a rigid thermoplastic such as, for example, polycarbonate.Drug cassette64 has an internal cavity that housesIV tubing76, preferably made of a flexible thermoplastic such as, for example, polypropylene (e.g., Kelcourt).Drug cassette64 accurately and reliably positions exposedIV tubing76 in contact with the peristaltic fingers ofperistaltic infusion pump72. IV tube set76 attaches tofluid vial68, and the majority of the length of IV tube set76 is contained withindrug cassette64. A small portion of IV tube set76 lies external todrug cassette64 to facilitate the interaction withperistaltic pump72.IV tubing76 is coiled withindrug cassette64 and has a length to reach a patient removed from theprocedure unit12. Mounted upon one inner wall ofdrug cassette64 isfluid detection sensor302.Fluid detection sensor302 may be any one of known fluid sensors, such as the MTI-2000 Fotonic Sensor, or the Microtrak-II CCD Laser Triangulation Sensor both by MTI Instruments Inc.Fluid detection sensor302 can be fixedly attached todrug cassette64 using an attachment means including, but not limited to, glue, mechanical fasteners, screws, and ultrasonic welding. Preferably, IV tube set76 runs throughfluid detection sensor302 before exitingdrug cassette64.
• In one embodiment of a method of operation,procedure unit12 in combination withdrug cassette64 andperistaltic infusion pump72 “auto prime”IV tubing76 so the clinician does not have to take the time to manuallyprime IV tubing76.Drug cassette64 provides interlocks during the “auto prime” process to prevent the clinician from accessing theIV tubing76 and inadvertently connectIV tubing76 to the patient. After the auto prime feature is complete, however, the interlock is disabled and the user is able to access theIV tubing76, through, for example an access door, which during the auto prime feature is locked in a closed position.
• Referring also toFIG. 4-A, a nurse or clinician initiates the auto priming system by pressing a button on either bedside touch screen assembly22 or procedure touch screen assembly62, step350. Upon receiving the command to initiate the auto priming system,peristaltic pump72 activates and begins a new pump cycle,step352.Peristaltic pump72 displaces fluid fromfluid vial68 through the length of IV tube set76, step354.Fluid detection sensor302 monitors the extreme end of the IV tube set76 for the presence of fluids,step356.
• Fluid detection sensor302 continuously monitors for the presence of fluid within IV tube set76,step356. If no fluid is detected, the nurse or technician is notified by either auditory or visual alert indicating that the auto priming process is not complete,step358. After the alert stating that priming is not complete is given, the main logic board commandsperistaltic infusion pump72 to continue operating,step352. This process continues through steps352-356 untilfluid detection sensor302 detects the presence of fluid and the main logic board commandsperistaltic infusion pump72 to stop until further notice,step360. After the pump cycle ceases, the nurse or technician is notified by either a visual alert on eitherbedside unit10 orprocedure unit12, or by an auditory alert indicating the auto priming system has successfully primed the pump,step362.
• FIG. 4-C shows an alternate embodiment of the automatic priming system.Fluid detection sensor302 is integrated withperistaltic pump72 or another stable structure adjacent todrug cassette64. In this embodiment,drug cassette64 contains two exposed portions of IV tube set76, afirst portion320, and asecond portion322.First portion320 allowsperistaltic pump72 to manipulate IV tube set76 in order to pump fluid through the line.Second portion322 is placed adjacent tofluid detection sensor302. Upon detection of fluid insecond portion322,peristaltic pump72 continues to operate for a short time to ensure that no air remains in IV tube set76. This time is determined by the main logic board located insideprocedure unit12 calculating the length of IV tube set76 downstreamsecond portion322 and the speed at whichperistaltic pump72 is operating. Upon the allotted time has expired,peristaltic pump72 will cease the pump cycle and IV tube set will be fully primed.
• Referring now toFIG. 5,communication cable14 contains a plurality of centralized pneumatic tubes surrounded by a plurality of electrical wires.Oxygen conduit100 is a pneumatic tube that delivers oxygen traveling from an external oxygen source throughprocedure unit12 tobedside unit10.Oxygen conduit100 runs the length ofcommunication cable14 and terminates at oralnasal cannula48. Exhaledgas conduit102 is also a pneumatic tube that transports a patient's exhaled respiratory gases from oralnasal cannula48 through cable pass-throughconnection15 and terminates inprocedure unit12.ECG conduit104 contains a plurality of electrical wires known as ECG leads51. ECG leads51 receive electrical signals fromECG pads50 that are communicated toprocedure unit12 for data processing.NIBP conductor106 transmits processed information of a patient's blood pressure frombedside unit10 toprocedure unit12.Pulse oximeter conductor108 transmits processed information of a patient's oxygen saturation level frombedside unit10 toprocedure unit12.ART response conductor110 transmits processed information regarding a patient's response to ART stimuli frombedside unit10 toprocedure unit12.
• As shown inFIG. 7, a data flow diagram outlines the typical process of the pre-procedure room. As shown, the patient arrives in the pre-procedure room,step200. A nurse or technician mountsbedside unit10 to either the bedrail or IV pole,step201.Bedside unit10 is equipped with an IV pole clamp or a quick connect to quickly and easily mount the unit on either the bedrail or IV pole. Oncebedside unit10 is in place, the nurse or clinician may connectNIBP cuff58 andpulse oximeter probe60 to the patient,step202. These connections are made between the patient andbedside unit10.Bedside unit10 will automatically begin monitoring parameters such as, for example, diastolic and systolic blood pressure, mean arterial pressure, pulse rate, oxygenation plethysmogram, and oximetry value, steps203,204. The readings taken bybedside unit10 will be displayed for the nurse or technician on bedside touch screen assembly22. While patient parameters are being monitored, the nurse or technician is free to perform other tasks. As is customary with current practice, the nurse or technician may need to complete a pre-procedure assessment,step206. The pre-procedure assessment may include recording patient vital signs, determining any known allergies, and determining patient's previous medical history. Once the nurse or technician has completed the pre-procedure assessment,step206, the nurse or technician may start the peripheral IV by placing a catheter in the patient's arm,step207. The IV catheter is connected to the primary IV drip device such as, for example, a 500 mL bag of saline fluid. Upon completion of the above activities, the nurse or technician begins to attachECG pads50,ART handpiece57, ART earpiece55 and oralnasal cannula48 to the patient, step208. Preferably, patient care system5 has the capability to automatically detect and recognize the proper connection of the monitors when they are connected from the patient tobedside unit10.
• Once the patient is connected to the above-mentioned items, the nurse or technician may explain ART system52 to the patient. This explanation may involve the nurse or technician instructing the patient to respond to auditory stimulation from ART earpiece55 and/or tactile stimulation fromART handpiece57 by squeezingART handpiece57. If the patient fails to respond to either auditory or tactile stimulation, the intensity of the stimulation will increase until the patient responds successfully. At this point, the nurse may initiate an automated ART training,step209. Automated ART training is a program run bybedside unit10 that teaches the patient how to detect an ART stimulus and how to respond to that stimulus and sets a baseline patient response to the stimulus as disclosed in the previously referenced U.S. patent application Ser. No. 10/674,160. The nurse or technician is free to perform other patient related tasks while the patient is participating in the automated ART training.Bedside unit10 will display the automated ART training status so the nurse or technician can quickly determine if the patient is participating in the automated training. The patient must successfully complete the automated ART training to proceed, step210; if the patient fails to complete the training a nurse or other clinician must intervene and determine if the patient may continue, step210-A. If the clinician decides the user may proceed, then the patient will proceed to step211; if the clinician decides the patient is unable to continue, then the procedure will be canceled,step213. The user may customize the automated ART training to automatically repeat at specified intervals (i.e. 10 minutes) if the patient is required to wait to enter the procedure room. This will help to instill the newly learned response.
• In addition to successfully completing automated ART training, the patients parameters must be in an acceptable range,step205. The clinician may decide upon what an acceptable range is by inputting this information intobedside unit10 by means of bedside touch screen assembly22. If any one of the parameters being monitored falls outside a given range, the patient will not be permitted to undergo a procedure until a nurse or other clinician examines the patient to determine whether or not the patient may continue, step205-A. If the clinician decides the patient is able to continue, the patient will proceed to step211, if the clinician decides the patient is unable to continue, then the procedure will be cancelled,step213. Just prior to leaving the pre-procedure room for the procedure room, the nurse administers a predetermined low dose of an analgesic drug, step211 such as, for example, a 1.5 mcg/kg of Fentanyl. After the injection of the analgesic drug, the patient is ready to be moved to the procedure room,step212.
• FIG. 8 is a flow chart illustrating the implementation of the invention while the patient is in the procedure room. As shown, the patient andbedside unit10 are moved into the procedure room, step220 and is received by the physician and procedure nurse.Bedside unit10 may be connected toprocedure unit12 upon the patient entering the procedure room, step221. Upon connection, the NIBP, pulse and oximetery history from the patient will automatically up-load toprocedure unit12 displaying patient history for the last period of monitoring. In addition to NIBP and pulse oximeter history, a record verifying the patient has completed ART training will also be uploaded. Upon connection ofbedside unit10 toprocedure unit12, the small display onbedside unit10 changes immediately from a monitoring screen to a remote entry screen forprocedure unit12. Display informationform bedside unit10 is automatically transferred toprocedure unit12.
• At this point, the procedure nurse may secure oralnasal cannula48 to the patient's face,step222.Procedure unit12 may begin monitoring patient parameters such as, for example, ART, ECG, and capnography now that all connections between the patient andprocedure unit12 are complete, step223.Procedure unit12 will continue monitoring patient parameters such as, for example, NIBP, pulse, and oximetery,step224. Next the procedure nurse may place and spike a standard drug vial,step225 ontodrug cassette64.Drug cassette64 has an integrated drug vial spike that serves to puncture the rubber vial stopper as well as to allow fluid from the drug vial to enterdrug cassette64. Next the procedure nurse needs to placedrug cassette64 adjacent toperistaltic infusion pump72 making sure that the exposed portion ofIV tubing76 lines up with the peristaltic fingers, step226. Once the fluid vial anddrug cassette64 are loaded correctly, the nurse may autoprimeIV tubing76. In one embodiment, the procedure nurse would press a button located uponprocedure unit12 to initiate the autopriming,step227. Autopriming is the automatic purging of air fromIV tubing76.procedure unit12 continuously monitors the autopriming process to determine the overall success of the autopriming. Ifprocedure unit12 fails to properly purgeIV tubing76, a warning notification is made to the user so that the procedure nurse may repeat the autopriming sequence untilIV tubing76 is successfully purged,step227.
• Upon successful completion of the autopriming sequence, the procedure nurse may enter the patient weight in pounds while the physician may enter the initial drug maintenance dose rate as well as dose method; normal or rapid infusion, step229. After the patient weight and dose rate have been inputted, the physician or procedure nurse may initiate drug infusion,step230. While the drug is taking effect upon the patient, the physician may perform standard procedure related activities such as, for example, test the scope, and apply any topical anesthetic. Once the drug has taken the desired effect upon the patient, the physician and procedure nurse are free to conduct the procedure,step231. Upon completion of the procedure, the clinician may disconnect the drug delivery cassette from the catheter,step232 and disconnect the bedside unit from the procedure unit,step233. If the clinician so desires,procedure unit12 may print a record of the patient's physiological parameters fromprinter70 at this time,step234. Included on the print out of the procedure record are patient monitoring data such as, for example, NIPB, pulse oximetery, capnography, respiration rate, and heart rate. Other system events included in the print out are, ART competency, ART responsiveness during the procedure, oxygen delivery history, drug dose, monitoring intervals, drug bolus amount and time, and total drug volume delivered during the procedure. The printout includes a section where the procedure nurse may enter in notes of her own, such as, for example, additional narcotic delivered, topical spray used, Ramsey Sedation Scale, procedure start and finish time, cautery unit and settings used, cautery grounding site, dilation equipment type and size, and Aldrete Score. After printing the patient record, the patient may then be moved to the recovery room,step235.
• As shown inFIG. 9, a flow chart illustrating the implementation of the invention while the patient is in the recovery room. As shown, the patient arrives in therecovery room240 still attached tobedside unit10 after leaving the procedure room. At this point,bedside unit10 may be operating on either battery or AC power. Upon entering the room, the attending clinician may remove the ECG pads, ECG lead wires, ART handpiece, and ART earpiece from thepatient241. Depending upon clinician preference and status of the patient, the patient may require supplemental oxygen while in therecovery room242. If the patient does require supplemental oxygen, oralnasal cannula48 is left on the patients face and oxygen is accessed from an external source such as, for example, a headwall or tank. The nurse or technician would disconnect oralnasal Cannula48 frombedside unit10, plug it directly into a standard oxygen delivery extension set, and set the desired oxygen flow rate, step243. If no supplemental oxygen is required in the recovery room, the nurse or technician may remove oralnasal cannula48 from the patient244.
• The nurse or technician may now organize ECG leads51 andART handpiece57 and place nearbedside unit10 to be used on the next patient245. The nurse or technician may need to fill out additional information on the patient record246. The nurse or technician will most likely write notes describing the patient's condition during recovery and record NIBP, pulse rate and oximetery values of the patient during recovery.ECG pads50 and oralnasal cannula48 may be discarded at this point into a standard waste container located in therecovery room247. It is important to note thatbedside unit10 is still collecting data related to NIBP, pulse rate, andpulse oximetery248. The nurse or technician must determine if the patient is ready to be discharged249. Criteria for discharge vary among patient care facilities; however an Alderate score of10 is common for discharge. Other measures of discharge criteria include skin color, pain assessment, IV site intact, NIBP, pulse, respiration rate, and oximetery values all must be close to the measurement taken in pre-procedure. If the patient does not meet any of these criteria, it is recommended that the patient receiveadditional monitoring248. Once a patient is cleared for discharge, the nurse or technician disconnectsNIBP cuff58,pulse oximeter Probe60, and if not done so already, oralnasal cannula48 from thepatient250. Once all the above is completed, the patient may be discharged from the care facility251.
• The foregoing description of several expressions of embodiments and methods of the invention has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the invention to the precise forms and procedures disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be defined by the claims appended hereto.

Claims (8)

We claim:

1. A method for monitoring a patient and delivering at least one drug during a medical procedure in a medical care facility comprising the steps of:

a) connecting to the patient at least one sensor for monitoring at least one physiological parameter of the patient;

b) obtaining a first housing having a first microprocessor-based patient unit having at least one first connection point for receiving input signals from the at least one sensor and at least one second connection point for outputting patient physiological parameters;

c) connecting the at least one second connection point to a second housing having a second microprocessor-based procedure unit, and performing a medical procedure on the patient, wherein at least a portion of the medical procedure is controlled by the second microprocessor-based procedure unit.

2. The method ofclaim 1 further comprising the steps of inputting to the first microprocessor-based patient unit physical attributes of the patient.

3. The method ofclaim 1 further comprising the steps of delivering the drug to the patient and performing a medical procedure.

4. The method ofclaim 3 further comprising the step of delivering oxygen to the patient.

5. The method ofclaim 3 further comprising the step of querying the patient to determine a level of consciousness of the patient.

6. The method ofclaim 5 further comprising the step of the patient activating a response device.

7. The method ofclaim 3 further comprising the step of delivering the drug via an IV tube and priming the IV tube before delivering the drug to the patient.

8. The method ofclaim 7, wherein priming the IV tube is automatically performed by the microprocessor-based procedure unit.

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