US20140095485A1 - Processing program data for medical pumps - Google Patents

Abstract

An apparatus for maintaining a library of program data for medical pumps, the apparatus comprising: memory loaded with a database, the database including a plurality of program data records and a plurality of data key records, each program data record containing a set of program data items, at least some of the program data items included in the database for controlling operation of a medical pump, each data key record containing a data key and each data key identifying one of the data program records; a database management system programmed to link a data key to a set of program data; and a scanner in data communication with the database management system, the database management system being further programmed to receive a code scanned by the scanner, save the code in a data key record, and link the code to a set of program data, the code being a data key.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 09/920,467 filed Aug. 1, 2001, which in turn is a continuation-in-part of U.S. patent application Ser. No. 09/631,000 filed on Aug. 2, 2000, which are hereby incorporated by reference.
TECHNICAL FIELD
• The present application relates to pumps for infusing fluids into a patient, and more particularly to processing data for programming pumps.
BACKGROUND
• There are a variety of different techniques and devices for infusing fluids, such as drugs or nutritional supplements, into a patient. One type of device that is used is an ambulatory drug pump. Such pumps are structured to pump an agent into a patient from a reservoir such as a cassette that attaches to the pump or an I.V. bag. Such a pump is versatile. They can be used for bed-ridden patients in a hospital or nursing home or they can be used for patients that are mobile and have a need to move freely.
• Additionally, these pumps are programmable so that they can deliver different types of agents and administer different types of therapies. For example, the pumps can be programmed to deliver nutritional supplements for a parenteral nutritional therapy, drugs for a chemotherapy therapy, pain-relief medication for a pain-control therapy for patient controlled analgesia program, and antibiotics for treating infections.
• These pumps may need to be programmed with a variety of program data before each use. Such program data might include delivery schedules and routines; data about the patient such as age, weight, or special medical conditions; and data about the agent such as dose and type of drug.
• A difficulty with these systems is that only one item of program data can be entered into the pump at a time—and then usually through a keyboard on the pump. Some systems allow the program data to be entered into the pump via a computer. But even these systems require the caregiver to load only one data item at a time into the pump. Programming the pump in this manner can require both a significant amount of time and caregiver training. Furthermore, many therapies and drugs require different pumps to be repeatedly programmed with the same sets of program data. This process is very time consuming and inefficient. Given the rising cost of health care, efficiency and increased automation are very important.
SUMMARY
• One aspect of the present invention is a method for creating a library of pump data on a computer having a database. The pump data is organized into sets of program data. Each set of program data is available for batch downloading to a medical pump and includes data items for controlling operation of the medical pump. The method comprises: entering a plurality of data items into a database on the computer, the plurality of data items forming a set of program data, at least some of the data items establishing parameters for controlling operation of a medical pump; and assigning at least one data key to the set of program data, the data key identifying the set of program data.
• An alternative aspect of the invention is an apparatus for maintaining a library of program data for medical pumps. The apparatus comprises memory loaded with a database. The database includes a plurality of program data records and a plurality of data key records. Each program data record contains a set of program data items, and at least some of the program data items included in the database are for controlling operation of a medical pump. Each data key record contains a data key and each data key identifies one of the data program records. A database management system is programmed to link a data key to a set of program data.
• Yet another alternative aspect of the invention is directed to an apparatus for batch programming a medical pump. The apparatus comprises memory loaded with a database. The database includes a plurality of program data records and a plurality of data key records. Each program data record contains a set of program data items, and at least some of the program data items included in the database are for controlling operation of a medical pump. Each data key record contains a data key and each data key identifies one of the data program records. A data output is configured for data communication with a programmable medical pump, and a processor is in electrical communication with the memory and the data output. The processor is configured to retrieve a set of program data from the database and batch download the set of program data to the medical pump.
• Still another aspect of the present invention is a method for batch programming a medical pump. The method comprises selecting a set of program data, the set of program data including data items for controlling operation of a medical pump; and batch downloading the set of program data to the medical pump, wherein the set of program data is downloaded to the medical pump without intervening action by a user after the first data item is downloaded to the computer.
DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates one possible environment in which the present invention can be embodied.
• FIG. 2 is a block diagram illustrating architecture for the computer shown inFIG. 1.
• FIG. 3 is a block diagram illustrating architecture for the pump shown inFIG. 1.
• FIGS. 4-6 illustrate a memory map for the pump shown inFIG. 3.
• FIGS. 7A-7C is a flow chart illustrating operations executed by the computer and pump shown inFIGS. 2 and 3.
• FIG. 8 illustrates the information management system shown inFIG. 1.
• FIG. 9 illustrates one possible user interface for use with the information management system described herein.
DETAILED DESCRIPTION
• A preferred embodiment of the invention will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to the preferred embodiment does not limit the scope of the invention, which is limited only by the scope of the claims attached hereto.
• In general terms, the present invention is directed to processing program data for a medical pump. The program data is stored in a database and includes a set of program data and a data key for referencing each set of program data. The set of program data includes data for programming the pump. Examples of the type of data that it can include includes parameters about the patient such as age and weight, delivery schedules, dose requirements, parameters limiting the size and frequency of a bolus the patient can self administer, and the like.
• In one aspect of the invention, a caregiver generates a database that includes sets of program data and data keys that identify each set of program data. In another aspect of the invention, the caregiver can then select a data key and load the program data associated with that key into the pump, thereby programming the pump without having to individually reenter each data item into the pump. Examples of data keys that can be used to identify sets of program data include patient names, drug names, or therapy names. Although particular aspects of the invention are discussed above, one skilled in the art will realize that many other aspects of the present invention are disclosed throughout this disclosure.
• The following discussion is intended to provide a brief, general description of a suitable computing environment in which the invention may be implemented. Although not required, the invention will be described in the general context of computer-executable instructions being executed by a computer.
• Additionally, the logical operations of the various embodiments of the invention described herein are implemented as: (1) a sequence of computer implemented steps running on a computing system; and/or (2) interconnected machine modules within the computing system. Modules represent functions executed by program code such as the code found in a dynamic-link library (DLL). The implementation used is a matter of choice dependent on the performance requirements of the pump and the computing systems with which it interfaces. Accordingly, the logical operations making up the embodiments of the invention described herein are referred to alternatively as operations, steps, or modules.
• FIG. 1 illustrates one possible computing environment in which the present invention can be embodied. Although one particular type of networking environment and computing platform is illustrated, one skilled in the art will realize that the invention can be embodied using any type of networking environment and computing platform. The invention can even be embodied on an individual, non-networked computer. In essence, the invention can be embodied using any type of computing platform and configuration that includes memory for storing a database and an interface for a programmable pump. Examples include a desk-top computer such as an IBM PC-compatible computer, a work station, a portable computer, a hand-held computer, or any other type of computer.
• A client/server network system generally shown as100, comprises anetwork server102 and a plurality ofcomputers104 such as desktop personal computers linked to a client/server network108. Thenetwork server102 and theindividual computers104 include an operating system and memory. As explained in more detail below, memory on theserver102 is loaded with aninformation management system106 having data keys and program data.
• Additionally, the client/server network108 can have any type of configuration. For example, the client/server network connections can be a local area network (LAN) using topologies such as Ethernet or token-ring, a wide area network (WAN), the Internet, or an Intranet. Additionally, the client/server network108 can be linked to theInternet116 via arouter114 andserver102.
• At least one of thecomputers104 connected to the client/server network108 is configured to be connected to amedical pump110 such as the Prizm® pump, which is commercially available from Sims Deltec, Inc. of St. Paul, Minn. The interface between thepump110 and thecomputer104 is serial and complies with theRS232 communication standard, although other communication protocols and interface configurations can be used. Furthermore, the communication link can be a physical cable, a radio frequency (RF) link, or an infrared (IR) link.
• At least one of thecomputers104 is also in communication with ascanner112. In one possible embodiment, thescanner112 is hand-held so that it can be easily used to scan barcodes physical objects such as I.V. bags, medicine packages, patient wristbands, and the like. Again, the communication link between the112 scanner and thecomputer104 complies with theRS232 communication standard. The communication link between thescanner112 and thecomputer104 can be a physical link, an RF link, or an IR link.
• Other embodiments use a scanner that shares an input with the computer keyboard. Such a scanner includes firmware or other programming that converts a scanned bar code to key strokes and inputs them into the computer. Yet other embodiments use a scanner other than a hand-held scanner.
• In yet another possible embodiment,computer104 is in communication with acommunication link113, which is for interfacing between thecomputer104 and a hand-held computer. Examples of such a communication link include a cradle and an infrared port.
• FIG. 2 illustrates one possible computer architecture and environment that can be used by computers to embody the present invention.Computer104 is a conventional personal computer and includes aprocessor unit202, a system memory204, and asystem bus206 that couples various system components including the system memory204 to theprocessor unit202. Thesystem bus206 may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus and a local bus using any of a variety of bus architectures. The system memory includes read only memory (ROM)208 and random access memory (RAM)210. A basic input/output system212 (BIOS), which contains basic routines that help transfer information between elements within thepersonal computer200, is stored inROM208.
• The memory also includes an operating system, application programs, program modules, and program data. The operating system is a program that controls and allocates usage of the computer's hardware services. The application program includes a kernel for managing memory, manages peripheral devices, launches applications, and allocates resources. Application programs are programs designed to assist the performance of specific tasks other than operation of the computer itself. The program modules includes utilities and other programs that are designed to perform specific tasks such as testing data, system diagnostics, communication protocols, and the like.
• Thecomputer104 further includes ahard disk drive212 for reading from and writing to a hard disk, amagnetic disk drive214 for reading from or writing to a removablemagnetic disk216, and anoptical disk drive218 for reading from or writing to a removableoptical disk219 such as a CD ROM, DVD, or other optical media. Thehard disk drive212,magnetic disk drive214, andoptical disk drive218 are connected to thesystem bus206 by a harddisk drive interface220, a magnetic disk drive interface222, and anoptical drive interface224, respectively. The drives and their associated computer-readable media provide nonvolatile storage of computer readable instructions, data structures, programs, and other data for thecomputer104.
• Although the exemplary environment described herein employs a hard disk, the removablemagnetic disk216, removableoptical disk219, and other types of computer-readable media capable of storing data can be used in the exemplary system. Examples of these other types of computer-readable mediums that can be used in the exemplary operating environment include magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, random access memories (RAMs), and read only memories (ROMs).
• A number of program modules may be stored on thehard disk212,magnetic disk216,optical disk219,ROM208 orRAM210, including anoperating system226, one ormore application programs228,other program modules230, andprogram data232. A user may enter commands and information into thecomputer104 through input devices such as a keyboard234 andmouse236 or other pointing device. Examples of other input devices may include a microphone, joystick, and scanner. These and other input devices are often connected to theprocessing unit202 through aserial port interface240 that is coupled to thesystem bus206. As discussed above, this interface can be a physical connection, RF, or IR. These input devices also may be connected by other interfaces, such as a parallel port or a universal serial bus (USB).
• Theserial port interface240 also provides a port for thecommunication link113, which is used to synchronize or otherwise communicate with a hand-held computer. As with the other devices, thecommunication link113 can interface with thecomputer104 using other interfaces such as a parallel port or a USB.
• Output devices are also connected to thesystem bus206 via an interface or driver. Examples of an output device include a monitor242 or other type of display device is also connected to thesystem bus206 via an interface, such as a video adapter244. In addition to the monitor242, personal computers typically include other peripheral output devices (not shown), such as speakers and printers. Another example of an output device is themedical pump112, as described herein, and a hand-held computer (not shown) that synchronizes with thecomputer104. Some devices such as themedical pump112 and hand-held computer can serve as both input and output devices.
• Additionally, the term hand-held computer is used broadly to mean any type of portable computing platform that can interface with the computer. Examples include hand-held computers, palm-held computers, and personal digital assistants (PDAs) executing the Windows CE™, Pocket PC™ or Palm™ operating systems. An example of such a palm-held computer is the Symbol PPT 2700 Series Pocket PCs, which includes an integrated scanner and has wireless LAN connectivity. The Symbol PPT 2700 is available from Symbol Technologies, Inc. or Holtsville, N.Y.
• As discussed above, thecomputer104 may operate in a networked environment using logical connections to one or more remote computers, such as aremote computer246. Theremote computer246 may be another personal computer, a server, a router, a network PC, a peer device or other common network node, and typically includes many or all of the elements described above relative to thecomputer104. The network connections include a local area network (LAN)248 and a wide area network (WAN)250. Such networking environments are commonplace in offices, enterprise-wide computer networks, intranets, and the Internet.
• When used in a LAN networking environment, thecomputer104 is connected to thelocal network248 through a network interface oradapter252. When used in a WAN networking environment, thecomputer104 typically includes a modem or other means (e.g., router114) for establishing communications over thewide area network250, such as theInternet116. Themodem254 is connected to thesystem bus206 via theserial port interface240. In a networked environment, program modules depicted relative to thepersonal computer200, or portions thereof, may be stored in the remote memory storage device. It will be appreciated that the network connections shown are exemplary, and other means of establishing a communications link between the computers may be used.
• One skilled in the art will recognize that the computer architecture illustrated inFIG. 2, on architectures similar thereto, can be used for theserver102 and for mobile computing platforms. Additionally, this architecture is exemplary only and thecomputers104,server102, and hand-held computers can be implemented using different architectures.
• FIGS. 3-6 illustrate one possible architecture for themedical pump110. Although a specific architecture is disclosed herein, one skilled in the art will realize that the present invention can be embodied with any type of programmable pump and that many different pump architectures are possible. In addition to the description set forth herein, additional information about programmable medical pumps and related technologies is set forth in U.S. Pat. No. 5,935,099, issued on Aug. 10, 1999, the disclosure of which is hereby incorporated by reference.
• FIG. 3 is a schematic of one possible control system300 for thepump110. Control system300 controls operation ofpump110, and includes amicroprocessor302 and amemory system304 programmable with program data for controlling operation ofpump mechanism306 and the other features ofpump110.
• Memory system304 stores various programs and program data related to the operation ofpump110, and is coupled tomicroprocessor302, which in turn runs the desired operating programs that control operation ofpump mechanism306.Memory system304 can include several different types of memory including aflash memory unit308, electrically erasable programmable read only memory (EEPROM)310, and a static random access memory (RAM)312. The program to permit communication with devices external to pump110 is stored inmemory system304.
• Access tomicroprocessor302 is provided throughcommunications port314. As discussed above,communications port314 is a standard RS232 communications port, although other communication protocols and links are possible (e.g., RF and IR). Information programmed intomemory system304 instructs information to be transmitted or received viacommunications port314. This feature allows information being received viacommunications port314 from an external device to controlpump110. This feature also allows for the downloading of any or all information frommemory system304 to an external device.
• Control system300 also includeskeyboard316 or other operator input structure for providing information tomicroprocessor302. When a key is pressed onkeyboard316, the key sends a signal tomicroprocessor302 indicative of the key being pressed.Microprocessor302 responds to the signal received in the desired manner. Other such input structures may include knobs, buttons, or other like structures for performing pump functions, such as starting, stopping, andpriming pump110.
• Display318 of control system300 includes structure for displaying information to the patient or caregiver. In one possible embodiment, thedisplay318 is a liquid crystal display (“LCD”) having a 4-line×21-character alpha/numeric display capable of creating 5×7 pixel characters. Display signals sent frommicroprocessor302 permit display of information related to the operation ofpump110.
• Pump110 also may be provided with a variety of sensors, switches, or other devices (hereinafter “sensors”). The type of sensors provided depends on the type of pump and its intended use. An example of such sensors includesocclusion detectors320 and322 for detecting occlusions in tubing used to infuse fluid from a reservoir to a patient. Further examples of desirable sensors forpump110 include acassette latch sensor324 for indicating whether a latch that latches the cassette to the control module on thepump110 is open or closed, acassette lock sensor326 for indicating whether the latch is locked, anair sensor328 for detecting air in tubing, and acassette identification sensor330. The sensors typically send a suitable electrical signal tomicroprocessor302 indicative of the condition sensed.Microprocessor302 andmemory304 are appropriately programmed to receive and process such signals.
• Pump110 also may be equipped withalarm332, such as a visual alarm (e.g., L.E.D.'s) and/or an audible alarm (e.g., beeper), which is activated by the sensing of one of the conditions mentioned above, or other conditions.Alarm332 may be activated as a result of other triggering events, such as error conditions with respect to the power supply or pump hardware. Alarm signals sent frommicroprocessor302 permit activation ofalarm332.
• In addition,external communication sensor334 senses when a communications cable connection or powered external serial device connection is made with respect to pump110 atcommunications port314. An appropriate signal is generated byexternal communication sensor334 and sent toprocessor302 indicative of the connection and/or the lack of connection with the communications cable or other connection device. In one possible embodiment, when a connection is detected, themicroprocessor302 will generate a flag that is communicated to thecomputer104 and indicative of a data communication. The flag serves as a handshake that hails the computer. The pump also enters into a connect mode, which is explained in more detail later.
• Optionally,external communication sensor334 can sense when a remote dose cord is attached, or when a remote data-gathering device (e.g., temperature sensor, blood pressure monitor, EKG monitor, or respiratory monitor) is attached. The remote dose cord also can be used by the patient as an event marker for storage inpump memory304. For example, the patient can use the remote dose cord to note a nauseous condition.
• The various sensors, switches, and devices that form or interface with thepump110 generate and/or receive an appropriate signal or signals during communication withmicroprocessor302 during operation ofpump110.Microprocessor302 is electrically interconnected through anappropriate interface bus336 with all of the various sensors, switches, and other devices ofpump112.Microprocessor302 responds to input signals by generating appropriate control output signals in accordance with the program control logic stored in memory. Onemicroprocessor302 that may be used in connection withpump110 is an MC68HC11E9 high-density complimentary metal-oxide semiconductor (HCMOS) high performance microcontroller unit (MCU) by Motorola. Such processor includes 512 bytes of electrically erasable programmable read only memory (EEPROM), and 512 bytes of random access memory (RAM). Other types of central processing units or programmable circuitry, such as a microcomputer can be used in place of themicroprocessor302.
• FIG. 4 illustrates how theflash memory308 is partitioned. Specifically, theflash memory240 includes seven program slots400a-400gfor storing a boot system program, four application programs, a terminal utility program, and a testing utility program. The application programs include a PCA application, which is for delivering drugs such as pain relief medication; an intermittent application, which is for intermittent delivery of drugs such as antibiotics; TPN application program, which is for administering fluids such as nutrients; and a continuous application program, which is for continuous administration of drugs such as chemotherapy medication.
• Physically, theflash memory308 is divided into sixteen banks. Each application program occupies three banks, each utility slot occupies one bank and the boot system occupies one bank. Additionally, theflash memory308 includes acore bank402. Although the programs stored in the flash memory are separate entities, they all share thecore bank402. Thecore bank402 is used to store pump drivers, a serial communication protocol, and a portion of the pump kernel. The code stored in the core bank is shared by all of the programs.
• Each application program, such as the PCA application, includes an application template, application-specific code, a pump kernel, a serial communication protocol, and pump drivers. The application program controls thepump110 after being launched by the boot system and performs additional self-tests. The pump application program then begins a review sequence during which various screens are generated and displayed showing the current values of selected application parameters.
• Additionally, in several possible embodiments, thepump110 displays on thedisplay318 the name of the application program with which the pump is currently programmed. In one possible embodiment, thepump110 might display the name of the application program as long as thepump110 is programmed with the application program. In another possible embodiment, thepump110 displays the name of the application program for a predetermined period of time when the application program is booted and then does not display the name of the program after the predetermined period of time lapses. Yet another possible embodiment, thepump110 will display the name of the application program upon receiving a command input through the keyboard234 or from other type of input. Additionally, each application program is the final arbiter of what data can and cannot be downloaded from theinformation management system106. In one possible embodiment, accordingly, each application program contains code for testing the data to determine whether it is valid data and is not corrupt.
• Although aflash memory318 loaded with four separate application programs is disclosed herein, other embodiments are possible. For example, theflash memory318 can be loaded with only a single application program or any number of other application programs. In another example, thepump110 can include memory of a type other than flash memory for storing an application program.
• Upon launching an application program, thepump110 will automatically stop thepump110 so that it is not in the normal pumping mode and thepump mechanism306 does not pump fluid. The caregiver can then program delivery parameters that control how thepump110 delivers fluid after it is restarted by pressing the START/STOP key. In yet another possible embodiment, thepump110 does not stop running when thepump110 is being programmed with new or updated delivery parameters. In yet another possible embodiment, the caregiver can selectively stop or disable thepump110 when it is being programmed with new delivery parameters.
• While thepump110 is running, it is in the normal pumping mode. Thepump110 will deliver fluid and keep track of delivery with status parameters while in the normal pumping mode. In one possible embodiment, none of the application parameters are changeable while thepump110 is in the normal pumping mode.
• The pump application template is a portion of the application program that provides consistency among the various pump application programs. It defines all standard application items, and the user interface structure that each application must follow to create custom application items. Standard application items define the characteristics of each application and can be supplanted with or added to by the application-specific program. The basic tasks performed by the pump application template include:
• 1. providing all standard menus and help screens, which are available for any specific pump application to use;
• 2. providing all standard application features, which are available for any specific pump application to use;
• 3. providing all standard application delivery, status, and configuration parameters, which are available for any specific pump application to use; and
• 4. providing all standard application alarms, which are available for any specific pump application to use.
• The application-specific code is a portion of application program that provides custom application items that are particular to the specific application. The application-specific code is used to customize the pump's110 behavior and can be programmed only while thepump110 is stopped. Custom application items may either replace or supplement the standard items provided by the pump application template. Basic tasks performed by a specific pump application include:
• 1. providing all custom menus and help screens to the kernel, including a start up menu to the kernel that lists the name and/or number of the specific pump applications;
• 2. providing all custom application features;
• 3. providing all custom application delivery, status, and configuration parameters to the kernel; and
• 4. providing all custom application alarms.
• Additionally, each application program is an event driven system. The pump drivers provide all hardware interfaces, and the pump kernel provides support services that include an event scheduling and a dispatching system. The serial communication protocol provides serial communication services with peripherals that are connected to thecommunications port314.
• A terminal utility is formed from the terminal code, the drivers, the kernel, and the serial communication protocol. The terminal controls the external modem and one of the applications running in thepump110 via the remote serial connection while program data is being downloaded to thememory system304.
• A testing utility is formed from the testing code, the drivers, the kernel, and the serial communication protocol. The testing utility is a stand-alone program that performs various tests on the pump hardware during closed-loop testing.
• FIG. 5 illustrates the basic configuration of theRAM312, which has four memory banks, Banks 0-3500a-500d. Bank 0500ais dedicated to a scratch memory.Bank 1500bhas four sets of addresses dedicated to configuration parameters for one of the application programs, a set of addresses dedicated to configuration of the application template, a set of addresses dedicated to the delivery status and parameters of the launch application, and a set of addresses dedicated to kernel data.Bank 2500cis dedicated to a history log.Bank 3500dis primarily dedicated to the history log. However, a set of addresses inBank 3500dis dedicated to kernel data.
• The scratch memory serves as a second layer of buffer that provides protection if there is an error in the data being downloaded or if there is a power failure while data is being written to theRAM312. During the write process, destination addresses will be designated to receive the data. However, data is first saved in the scratch memory. After the data is saved in the scratch memory, the application program analyses it to determine whether it has an errors or is otherwise corrupt. If the data is acceptable and does not contain any errors that are detected by the application program, it will be saved to the destination addresses. In one embodiment, data is written to and read from the scratch memory in blocks using an error-checking scheme or algorithm such as cyclic redundancy code (“CRC”).
• A first flag will be set while data is being written to the scratch memory. A second flag is set after the write process is complete at which time it is written from the scratch memory to the destination addresses. Because theRAM312 is a static RAM, either the first or second flag will be saved if thepump110 has a power failure.
• When power is returned to thepump110, the flag will be read. If the first flag is set, thepump110 either can disregard the data in the scratch memory or can complete the process of saving data to the scratch memory. If the second flag is set when power is returned to thepump110, thepump110 either can rewrite all of the data from the scratch memory to the destination address or can merely complete the write process from the scratch memory to the destination addresses.
• An advantage of using the scratch memory in this manner is that the integrity of the data is maintained while being written to the RAM, which will help minimize the risk of a pump failure, faulty information being stored in the history log, or faulty program data being downloaded from theinformation management system106 to thepump110.
• The scratch memory is also used for system diagnostics during power up. The boot program will initially test the scratch memory, which is Bank 0500a. Data fromBank 1500bis then transferred to the scratch memory so that thepump110 can run diagnostics on that bank. A similar procedure is followed withbanks 2 and 3500cand500d.
• The four sets of addresses inBank 1500bfor application configuration parameters are used to store persistent data, i.e., parameters that typically remain constant when a particular application program is being used. An example of such data might include the maximum and minimum flow rates or the maximum or minimum concentration settings.
• A set of addresses for the application template configuration includes the data that is common between application programs. An application might include the lock level setting or a flag that activates the automatic lock level feature. Addresses for the delivery status and parameter of the launch program are used to store data that is not persistent, including various settings for the launch program. Examples of such data include the delivery rate and dosage. The history log is used to track various historical events such as a change in the delivery rate or when apump110 is powered up with time and date stamps.
• FIG. 6 illustrates the configuration of theEEPROM310, which is less volatile than theRAM312. Thus, theEEPROM310 is used to store data that is more sensitive than the data stored in theRAM312. Examples of such data include various look-up tables, manufacturer parameters such as the pump serial number, odometers that record data such as hours of use and amount of drug delivered, and an error log to record system faults and nonrecoverable errors. TheEEPROM310 has sets of addresses dedicated to application configuration parameters, application template configuration parameters, launch application delivery and status parameters, kernel data, error log, and manufacturing parameters.
• Although the description set forth herein is directed to an exemplary embodiment of apump110, one skilled in the art will realize that the present invention can be embodied using many different types of programmable medical pumps. In fact, one possible embodiment includes an interface for communication between thepump110 and thecomputer104. The interface permits a single computer and itsinformation management system106 to interface with a variety of different programmable pumps, even pumps having different data structures and architectures.
• The interface program will determine the type ofpump110 that is connected to thecomputer104 and then facilitate data communication between thepump110 and the database management system that handles requests for database actions. The interface program can convert data between the format required by the pump and the format required by the database.
• Referring toFIG. 8, theinformation management system106 includes a database management system (DBMS)800 and adatabase802.
• TheDBMS800 provides an interface between thedatabase802 and users of thedatabase802, including both the caregiver and thepump110 itself. TheDBMS800 includesutilities804 such as test utilities for performing diagnostics and system tests; communication protocols for providing communication between theinformation management system106 and the pump's application programs; a diplomat, which will be described in more detail below, that tests the compatibility between the pump's programs and theinformation management system106 before exchanging data. Thedatabase802 includes adata storage area806 and adatabase engine808 for linking theDBMS800 with data in thedata storage area806.
• Theinformation management system106 can be programmed using any data manipulation language, including a structured query language (SQL). Additionally, any number of commercially available database application programs can be used to develop the pump management system. An example of a commercially available application program includes dBASE™, which is commercially available from dBASE, Inc. of Vestal, N.Y. Another database that can be used is Microsoft Access™, which is commercially available from Microsoft Corporation of Redmond, Wash.
• Many possible embodiments and data structures for data in thedata storage area806 are possible. For example, the data can be structured using arrays, records, or linked lists. In one possible embodiment, thedatabase802 is a relational database that is formed with two data tables810 and812.
• The first data table810 contains a plurality ofrecords814 relating to data keys. Each data key identifies a set of program data that can be down loaded into a medical pump and includes three fields. The first field identifies the type of data key. In one possible embodiment they types of keys that are available include the name of a therapy, the name of a drug, and the name of a patient. The second field is the actual name of the data key that is meaningful to a caregiver (e.g., a patient's name). The third field is a unique identification formed from a string of characters.
• The second data table812 similarly includes a plurality of data records816. Eachrecord816 is linked to at least one of the data keys of the first data table810 and includes program data that sets parameters for the pump's110 application program to run. The program data includes application configuration parameters and can include both persistent and non-persistent data. In one possible embodiment, each record includes data fields for persistent data such as a serial number; time and date parameters; programming unit parameters; concentration parameters; custom concentrations parameters, which is a list of concentration values for mg and mcg and their enabled state; continuous rate parameter; delivery limit parameter; delivery time parameter; demand dose amount parameter; dose counters clear flag, which clears the counters that track the number of times a bolus is request; demand dose lockout parameter, which sets the time minimum interval between bolus; given clear flag, which clears various odometers; reservoir volume parameter; air detector required parameter; air detector activated parameter; auto lock parameter, which is a parameter establishing a lockout feature for the pump keyboard; beep enable parameter; clinician bolus code parameter, which is a code or password that allows a caregiver to administer a bolus according to parameters set up for the caregiver as opposed to the patient; date format parameter; epidural mode parameter; lock code parameter; lock level parameter; main display and power source status display parameters, which allow the caregiver to customize the information displayed on the pump display; custom data feature settings, including a list of features of the reported loop and their enabled status; maximum rate parameter, which is the maximum rate that the pump mechanism will deliver fluid; new patient marker parameter, which sets up the pump for new patient (e.g., clears patient event logs); pm interval parameter, which is a preventative maintenance interval; reservoir volume alert parameter; titration limit parameter; upstream sensor enable parameter; and custom text strings, which are character strings displayed on the pump display.
• One skilled in the art will recognize that other possible embodiments of theInformation Management System106 and thedatabase802 are possible. For example, the program data can include any data that is related to the pump's110 application programs or that is generally used in operation of thepump110.
• In yet another possible embodiment, the database includes program code for operation of the pump. In this embodiment, thedatabase802 could include an entire application program, or components of an application program such as an application template, application-specific code, a pump kernel, communication protocol, or various pump drivers. In this embodiment, theinformation management system106 could automatically download and launch the pump's110 application program rather than having a caregiver manually load and launch the application program. Theinformation management system106 could also automatically scan thememory system304 in thepump110 to ensure that thepump110 is programmed with all of the relative software upgrades and download any upgrades that are not yet loaded onto thepump110. The database can include other software or code that is not directly associated with the pump's110 application program.
• In yet another embodiment, the program data includes a flag or other information identifying an application program that thepump110 should execute. When the program data is downloaded, thepump110 detects this flag and automatically launches the predetermined application program from theflash memory308.
• FIGS. 7A-7C illustrate one possible set of procedural steps followed when using amedical pump110 andinformation management system106 as described herein. Initially a caregiver launches the desired application program, operation700, that is loaded in theflash memory308 of themedical pump110. Execution of the application program is then stoppedoperation702, and the caregiver connects the communication cable from thecomputer104 to theserial communication port314 of themedical pump110,operation704. Atoperations706 and708, the pump kernel sets a disable flag if execution of the application program is stopped.
• If theexternal communication sensor334 detects the communication cable atoperation710, the pump kernel sends a signal to theinformation management system106 that is loaded on thecomputer104,operation712. This action hails the computer. Thepump110 also enters into connect mode, and in one possible embodiment, the application program is taken out of run mode so that they pumpmechanism306 is disabled. In one possible embodiment, the diplomat utility of theDBMS800 receives the disabled flag and enters communication with the pump's110 application program. In an alternative embodiment, the diplomat utility enters into communication with a test utility loaded on themedical pump110. This alternative embodiment might be used if the batch download process described herein will download program code to thepump110 as well as program data. Atoperations714 and716, the diplomat utility in theDBMS800 receives information about the version of application program loaded on thepump110 and determines whether theinformation management system106 is compatible with the pump's110 application software. Similarly, the test utility on thepump110 receives information about theinformation management system106, and determines whether it can interface with theinformation management system106. If either of the diplomat utility ofDBMS800 or the pump's110 test utility determines that there is no compatibility, the utility detecting the incompatibility will generate an error,operation716, and no program data will be communicated between thedatabase802 of theinformation management system106 and thepump110.
• Referring toFIG. 7B, if theinformation management system106 and the pump's110 application program are compatible, theDBMS800 generates a user interface, prompting the caregiver to choose between downloading program data to apump110 or uploading program data from apump110 into thedatabase802, operation720. There are a variety of scenarios in which a caregiver might choose whether to upload or download program data.
• For example, the caregiver might choose to download data to thepump110 to use preexisting data that is already stored in thedatabase802. This procedure saves the caregiver time because he or she will not have to individually program each data item. The caregiver might choose to upload data from apump110 to clone a pump's programming for future use with that same pump or with other pumps. The caregiver might also choose to upload data if it is necessary to modify some of the program data. Uploading the data allows the caregiver to edit the data using the keyboard234 andmouse236 on thecomputer104, which can be more efficient than indexing through each of the program data items using the keyboard on thepump110. Although one can create a record in thedatabase802 by cloning an existing pump, the caregiver can also create a record by entering data into thedatabase802 using the keyboard234 andmouse236 on thecomputer104.
• If the caregiver chooses to download data from thedatabase802 of theinformation management system106 to thepump110, he or she will select the type of data key to be used in retrieval of the desired set of program data and then enter the data key,operations722 and724. In one possible embodiment, there are three types of data keys that the user can select and use—the patient, therapy, or drug. The caregiver can enter the data in several formats. For example, one possible embodiment allows the caregiver to enter the name of the data key in prose (e.g., “John Doe” for a patient, “morphine” for a drug). In another embodiment, the caregiver enters an I. D. for the data key. The I.D. is an alpha/numeric character string and can be entered using the computer keyboard234. Alternatively, thecomputer104 might include ascanner112 and related utilities. The drug, patient, or therapy might have an I.D. embodied in a bar code that the caregiver scans. A utility or some other program module then communicates the scanned I.D. to theDBMS800, which retrieves the set of program data associated with the data key. The program data is retrieved from the second table812 of thedatabase802.
• In yet another possible embodiment, the caregiver will have the patient's hospital record on the screen. The hospital record may include personal data about the patient such as age, weight, and the like. The user interface displaying the client record includes a pump program button that the user activates to begin the process of programming apump110 with the delivery parameters. During the programming process, the data personal to the patient such as weight and age are automatically retrieved from the client record database and downloaded to thepump110 together with the program data.
• As discussed above, thecomputer104 receives information about the version of the application program loaded in the pump110 (operations714 and716). In this embodiment, thecomputer104 determines the program data that is compatible with the application program, retrieves the data from thedatabase802 using a data key and combines the program data with any personal data from the patient that is required to complete programming of thepump110. In one possible embodiment, if there are different records or sets of program data that can be used with the application program (e.g. pain relief for an adult and pain relief for a child), thecomputer104 will prompt the caregiver to select the appropriate record of program data.
• Alternatively, the user interface includes buttons corresponding to the various program data that can be downloaded into thepump110. The caregiver then clicks on the desired button, which is associated with a data key and initiates the process of programming the pump with program data. In still another possible embodiment, thecomputer104 generates the program data and then downloads it to the pump rather than retrieving it from thedatabase104. In this embodiment, the caregiver activates a button on the user interface of thecomputer104 that is displaying the patient record.Computer104 then executes a plurality of rules that examines personal data about the patient and generates the program data for downloading to thepump110.
• There are several possible ways in which thecomputer104 can determine the type of application program for which it is generating program data. For example, thecomputer104 can include rules to examine the patient record and determine why they are being treated at the hospital. If the record indicates the patient is receiving chemotherapy, the rules will direct thecomputer104 to create program data to deliver chemotherapy drugs to the patient. Similarly, if the patient is in for surgery, the computer can generate program data for delivering pain medication to the patient. If there are two or more possible uses for thepump110, the computer might generate a screen giving the caregiver options for what type of application the pump is being programmed. In this embodiment, thecomputer104, also might select and download the program code to thepump110 as well as the program data.
• In another example, thecomputer104 receives information about the application program loaded in the pump, including the identity of the version of the application program, duringoperation714 and716 as discussed above. Thecomputer104 then knows the type of program data that it must generate and proceeds to generate and download the program data. In yet another possible example, the user interface displaying the patient record includes a plurality of buttons, one for each type of application program that can be loaded onto thepump110. When a caregiver desires to program a pump, they activate the button and the computer generates the program data.
• Thecomputer104 can do several different things with the program data that it generates. For example, it can erase the program data after it is downloaded to thepump110. Alternatively, thecomputer104 can store the program data in thedatabase802 or in some other database or memory. The data record storing the saved program data can be linked to a data key such as a patient I.D. that identifies the patient for easy reference in the future, although any data key or file name can be used to identify the record of program data.
• Atoperations726 and728, the caregiver can edit the program data received from thedatabase802. The caregiver might edit the data for a variety of reasons. For example, the caregiver might edit dose requirements based on the patient weight or amount of pain the patient is experiencing. One possible embodiment of a user interface900 that is displayed on the monitor242 of thecomputer104 for adjusting the delivery protocol is illustrated inFIG. 9. Examples of data that can be adjusted or set include: time and date parameters902; programmingunit parameters904;concentration parameters906; continuous rate parameter908; delivery limit parameter910; demand dose amount parameter912; demand dose lockout parameter914; reservoirvolume alert parameter916; air detector activated parameter918; epidural mode parameter920; and lock level parameter922. The program data can be edited by using standard data entry techniques such as entering data into afield924 via a keyboard234, clicking onbuttons926 to index a preset value up or down, clicking a button928 to access a pull-down menu of possible data that can be entered in the corresponding field, and clicking on abox930 to set or disable a flag or similar marker.
• Atoperation730, the caregiver determines whether to save the edited data. If the caregiver chooses to save the edited data, he or she must decide,operation731, whether to overwrite the existing set of program data or save the data as a new set of program data. If the caregiver chooses to overwrite the existing program data, he or she will activate a save button on the user interface andoperation744 will store the edited program data by overwriting the set of program data that was originally retrieved from thedatabase802. If the caregiver chooses to save the edited program data as a new record and preserve the program data originally retrieved from thedatabase802, he or she will enter a new data key,operation742, and then activate a button on the interface to instruct theDBMS800 to save the new data key in the first data table810 and to save the edited set of program data as a new record in the second data table812 and to link the new record to the new data key.
• Atoperation732 the application program of the pump program manager determines whether the pump sent a disable flag to the computer. If the disable flag was received,operation734 downloads the program data to thepump110 using the scratch memory as described above. In one possible embodiment, the data key is also downloaded to the pump so that the program data can be easily identified.
• In one possible embodiment, however, the type of edited program data that can be downloaded to thepump110 is limited if thepump110 is not disabled and the pump is still in the run mode (i.e., thepump mechanism306 is still running). In such an embodiment, for example, the only modified program data that can be downloaded to thepump110 is data defining the delivery rate for the fluid, bolus amount, time between boluses, and volume delivered limit. In such an embodiment, if the disable flag is not set, the application program compares the program data that is being edited to a list of permissible data changes, operation736. If any of the requested data changes are not found in the list of permissible data changes, the application program rejects the data that was downloaded from theinformation management system106 and sends a rejected-data signal to theDBMS800. In one possible, embodiment the information management system automatically attempts to re-download the data to thepump110. In an alternative embodiment, the information management system generates an error that is displayed on the monitor242. If all of the data changes are found in the list of permissible data changes, and there are not other errors in the data that are detected by the application program, the pump will accept the data and transfer the data from the scratch memory to its destination addresses.
• If the caregiver chooses to upload program data from thepump110 to theinformation management system106, the caregiver activates an upload data button on the user interface of theinformation management system106 on thecomputer104. Atoperation746, the program data is uploaded from thepump110 to theinformation management system106. Atoperations748 theDBMS800 determines whether the program data was originally retrieved from thedatabase802. In one possible embodiment, if the program data was originally loaded on thepump110 from thedatabase802 of theinformation management system106, the data key that identifies the program data is also uploaded from thepump110 to theinformation management system106. If the program data was originally programmed on thepump110 and not previously downloaded from thedatabase802 of theinformation management system106, theDBMS800 prompts the user to select a type of data key, operation750, and to enter a 10 data key, operation752.
• Atoperation754, the caregiver then chooses whether to edit the program data that was uploaded form thepump110. If the caregiver chooses to modify the program data,operation728 is executed as described above. If the caregiver chooses to not modify the program data,operation742 is executed as described above.
• In one possible embodiment, when data including the program data is downloaded to thepump110 atoperation734, theDBMS800 maintains the program data inRAM210 regardless of whether the program data is saved in thedatabase802 atoperation744. After the data is downloaded to thepump110,operation734, thepump110 returns the program data to theDBMS800, which compares the returned program data to the program data temporarily stored inRAM210. At operations758-764, if program data returned from thepump110 and the program data temporarily stored inRAM210 match, a utility executed by thecomputer104 generates a message on the computer display242 stating thepump110 was successfully programmed operation762. The caregiver then disconnects thepump110 from the computer atoperation764. If the program data returned by thepump110 does not match the program data temporarily stored inRAM210, atoperation766 theDBMS800 generates an error and communicates the error to thepump110. If thepump110 receives this error, the application program will not accept the data downloaded from the information management system.
• As one skilled in the art will appreciate, there are many possible alternative embodiments to the systems, hardware platforms, and programs disclosed herein. The operations described above can be executed in different order, can include operations that are not described herein, and can exclude operations that are described herein.
• Furthermore, the invention described herein can be used in a variety of different environments and in a variety of different applications. For example, the system can be used in a hospital, nursing home, clinic, or any other environment. The system also can be used across more than one facility. For example, a pharmacist might create a set of program data and then download it into thedatabase802. A caregiver can then access that set program data for programming and management of thepumps110. Similarly, access to thedatabase802 can be through a standalone computer, through a computer directly linked to alocal network108, or through a computer remotely linked through a wide area network such as theInternet116.
• In yet another embodiment, the program data can be loaded into a hand-held computing platform such as the Symbol PPT 2700 Series Pocket PC as described above. The hand-held computer has a local database that can be synchronized with thedatabase802 of theinformation management system106. In one possible embodiment, the hand-held computer is loaded with all program data required for programming apump110 and can include program data for several different application programs and for several different therapies. Thus for example, the hand-held computer might be loaded with the delivery parameters for delivering pain medication to a typical adult (e.g. PCA Standard) and another for delivering pain medication to a child (PCA Pediatric). These programs might include different program data such as different delivery rates and different bolus limits. When programming the caregiver can then select the appropriate set or record of program data, establish a communication link between thepump110 and the hand-held computer, and download the program data. In another possible embodiment, the PDA can also be used to link with thepump110 and upload information for generating reports such as alarms and dose counters.
• In addition to being loaded with standard program data for a given application program, the hand-held computer also could be loaded with the program code and with data that is personal to a patient such as age and weight. The personal data might be downloaded to the hand-held computer from the client-records database of the clinic or hospital when making rounds or visiting patients, the caregiver can then select the patient whose pump is being programmed and the hand-held computer will download this personal data into the pump as well as other program data.
• In an alternative embodiment, the hand-held computer is loaded with the patient records for patients that are currently being treated at the clinic, hospital, or by the caregiver to which the hand-held is assigned. The hand-held generates the program data similar to the manner in which thecomputer104 can selectively generate the program data using rules as described above. The hand-held computer downloads the program data and/or the program code to thepump110. Additionally, in one embodiment, the hand-held stores the newly generated program data and synchronizes it to thecomputer104 for storage as described above. Alternatively, the hand-held computer erases the program data after it is downloaded to thepump110.
• In still another possible embodiment, a user interface is generated on the display of the hand-held computer that allows the caregiver to adjust the program data and to enter personal data about the patient such as age and weight.
• Additionally, the hand-held computer may include a scanner that allows it to scan a bar code on a drug package such as an I.V. bag or a patient I.D. one a wristband. The related program data is then retrieved from a database locally stored on the hand-held computer and is downloaded to thepump110. Alternatively, the caregiver can upload data, including the program data and data key, from thepump110 to the hand-held computer. The data can then be locally stored in the hand-held computer. The database local on the hand-held computer can be synchronized with thedatabase802 on theinformation management system106.
• In addition to the embodiment described herein, the hand-held computer can include a wireless radio that allows it to communicate with the server or other computer through radio frequency (RF) communication and without a direct physical link. An example of such a wireless hand-held computer is the Palm VII™, which is commercially available from 3COM Corporation of Santa Clara, Calif. In this embodiment, the wireless hand-held computer can communicate in real time with the server, which allows it to always have access to the most current program data and program code.
• Similarly, the wireless hand-held may also have real time access to the client record database so that it has access to personal data about the patient. In this embodiment, the wireless hand-held computer may be programmed to access a client record and generate program data to download to thepump110. Alternatively, the wireless hand-held can send a signal to thecomputer104, which initiates generation of the program data by thecomputer104 and communicates the generated program data back to the wireless hand-held computer. The wireless hand-held also can access program code to download to thepump110. Any program data that the wireless held-held computer generates can be uploaded to thecomputer104 either through a wireless connection or through a physical communication link.
• Although the certain descriptions have been made about functions performed by thecomputer104 and certain communication with thecomputer104, it is to be understood that these functions can be performed by, and communications made with, theserver102 or any other computing device.
• The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Those skilled in the art will readily recognize various modifications and changes that may be made to the present invention without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the present invention, which is set forth in the following claims.

Claims (24)

1-20. (canceled)

21. An apparatus for programming a medical pump, comprising:

memory storing a database, the database including a plurality of sets of program data, at least some of the program data for controlling operation of a medical pump;

a data output configured for data communication with a programmable medical pump; and

a processor in electrical communication with the memory and the data output, the processor configured to:

communicate with the medical pump to determine at least one characteristic of the medical pump;

determine a set of program data in the database that is compatible with the medical pump based on the at least one characteristic;

retrieve the set of program data from the database; and

download the set of program data to the medical pump.

22. The apparatus ofclaim 21, wherein the at least one characteristic is a type of the medical pump.

23. The apparatus ofclaim 21, wherein the at least one characteristic is a data structure of the medical pump.

24. The apparatus ofclaim 21, wherein the at least one characteristic is a data format required by the medical pump for data downloaded to the medical pump.

25. The apparatus ofclaim 21, wherein the processor is further configured to convert the set of program data into a format required by the medical pump.

26. The apparatus ofclaim 21, wherein at least some of the program data is individualized, patient-specific parameters for controlling operation of the medical pump for a specific patient.

27. The apparatus ofclaim 21, wherein the data output is configured for data communication with a plurality of different types of medical pumps and the processor is capable of downloading compatible program data to the plurality of different types of medical pumps.

28. The apparatus ofclaim 27, wherein at least some of the plurality of different types of medical pumps require program data to be received in at least one different format from other types of the plurality of types of medical pumps.

29. The apparatus ofclaim 21, wherein the processor is adapted to communicate with the medical pump through a wireless connection.

30. A method of programming a medical pump, comprising:

establishing a communications link between a processor having access to a database and a medical pump, the database including a plurality of sets of program data, at least some of the program data for controlling operation of the medical pump;

determining at least one characteristic of the medical pump;

determining a set of program data in the database that is compatible with the medical pump based on the at least one characteristic;

retrieving the set of program data from the database; and

downloading the set of program data to the medical pump.

31. The method ofclaim 30, wherein the at least one characteristic is a type of the medical pump.

32. The method ofclaim 30, wherein the at least one characteristic is a data structure of the medical pump.

33. The method ofclaim 30, wherein the at least one characteristic is a data format required by the medical pump for data downloaded to the medical pump.

34. The method ofclaim 30, further comprising converting the set of program data into a format required by the medical pump.

35. The method ofclaim 30, wherein at least some of the program data is individualized, patient-specific parameters for controlling operation of the medical pump for a specific patient.

36. The method ofclaim 30, wherein the processor is configured to establish a communications link with a plurality of different types of medical pumps and the processor is capable of downloading compatible program data to the plurality of different types of medical pumps.

37. The method ofclaim 36, wherein at least some of the plurality of different types of medical pumps require program data to be received in at least one different format from other types of the plurality of types of medical pumps.

38. The method ofclaim 30, wherein establishing a communications link between a processor having access to a database and a medical pump establishes a wireless connection between the processor and the medical pump.

39. An apparatus for programming a medical pump, comprising:

an electronic database containing a plurality of sets of program data, at least some of the program data for controlling operation of a medical pump;

a database management system having access to the database and including a user interface; and

a processor in electrical communication with the database management system, the processor configured to:

establish communication with the medical pump;

determine at least one characteristic of the medical pump;

access the database to determine a set of program data in the database that is compatible with the medical pump based on the at least one characteristic;

retrieve the set of program data from the database; and

download the set of program data to the medical pump.

40. The apparatus ofclaim 39, wherein the at least one characteristic is selected from the group consisting of: a type of the medical pump, a data structure of the medical pump and a data format required by the medical pump for data downloaded to the medical pump.

41. The apparatus ofclaim 39, wherein the processor is further configured to convert the set of program data into a format required by the medical pump.

42. The apparatus ofclaim 39, wherein at least some of the program data is individualized, patient-specific parameters for controlling operation of the medical pump for a specific patient.

43. The apparatus ofclaim 39, wherein the processor is adapted to communicate with the medical pump through a wireless connection.

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