EP0620940A1 - Plan de configuration de pompe de perfusion utiisant des memoires eeprom - Google Patents

Plan de configuration de pompe de perfusion utiisant des memoires eeprom

Info

Publication number
EP0620940A1
EP0620940A1 EP93914317A EP93914317A EP0620940A1 EP 0620940 A1 EP0620940 A1 EP 0620940A1 EP 93914317 A EP93914317 A EP 93914317A EP 93914317 A EP93914317 A EP 93914317A EP 0620940 A1 EP0620940 A1 EP 0620940A1
Authority
EP
European Patent Office
Prior art keywords
pump
memory
assembly
microprocessor
mode
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP93914317A
Other languages
German (de)
English (en)
Other versions
EP0620940A4 (fr
Inventor
John Gillespie, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of EP0620940A1 publication Critical patent/EP0620940A1/fr
Publication of EP0620940A4 publication Critical patent/EP0620940A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

Definitions

  • This invention pertains to a microprocessor-controlled infusion pump which is field programmable to a desired configuration, said configuration being stored in a non-volatile memory.
  • the user can configure or customize the infusion pump to conform to his standard usage protocol.
  • Microprocessor-controlled infusion pumps have become widely accepted and used in hospitals for the delivery of a variety of medications. These types of devices are particularly useful for post ⁇ operative pain management wherein a pain relieving medication is administered to the patient at a small infusion rate. These types of devices are especially useful for Patient Controlled Analgesia (PCA) procedures wherein within certain time constraints, a patient may request and receive an additional pain relieving dose.
  • PCA Patient Controlled Analgesia
  • a user can select a constant infusion rate, as well as parameters to define a patient requestable dose. Based on the information programmed into the pump by the doctor, the pump can automatically administer pain medication at the patient's push-button request. The patient is only permitted to receive a dose after a certain amount of time has passed since the last dose.
  • Another approach that is used is to present the user with lists of programming options, or menus. At each juncture in the programming where a choice must be made, the user must select a choice from a list.
  • Another solution is to use some sort of device or switch to customize the operation of the pump for its typical usage.
  • a good example of this is Bard's patented Smart Label system for its InfusO.R. tm pump wherein different magnetically coded labels on the front of the pump allow users to customize their pump for a specific drug.
  • the same pump also has a slide switch that allows users to select the brand of syringe they will be using with the pump.
  • Yet another solution would be to use some sort of cartridge or cassette that can be inserted into the pump to provide the information required to customize the pump.
  • This sort of system achieves the goal of a flexible customizable pump, nevertheless, such a system may add significantly to the cost of the product.
  • Each of these two solutions also adds costly accessories (the labels, cartridges or cassettes) to the pump which could be misplaced. Misplacing one of these accessories could result in needless down-time for a potentially very expensive piece of equipment.
  • programmable infusion pumps are advantageous because a single pump can be programmed by a health practitioner, a pharmacist, or nurse, in accordance with standard protocol set up by hospitals, to perform a large number of functions.
  • a single pump can be set up to perform the functions, and replace a variety of pumps dedicated for specific functions. This advantageously reduces expenses to hospitals related to both the cost of acquiring medical equipment and inventory control.
  • a pump motor controlled by a microprocessor delivers the contents of the bag through a tube.
  • the operational parameters are entered through the keypad in response to prompts from the LCD panel, during an initializing program as set forth in the flow chart 100 of Figure 1.
  • the first step, step 102, of this program requires is a request for a security code. A person may not alter the pump parameters without this code.
  • a security code is entered at the factory and may be changed by using a special sequence of commands. This code is stored in a special static RAM of the pump powered by its own battery.
  • step 102 the security code is requested and compared to the code in the static RAM. If the code is correct, the program moves onto step 10 .
  • step 104 the volume of the bag is entered for example in mi's.
  • step 106 the pump is primed.
  • step 108 the concentration of the medicine in the bag is entered.
  • a special subroutine is run to allow the operator to select the concentration in either mis, or mgs. Thereafter, all parameters are selected and displayed in the selected units.
  • step 110 the PCA dose, the amount of medicine to be administered upon a patient request, is set.
  • step 112 the minimum delay between PCA doses is set (normally in minutes) .
  • step 114 the basal rate is set.
  • step 116 the total hourly limit is set. The hourly limit consists of the total basal rate plus the PCA doses that can be delivered in a given hour.
  • step 118 the initial loading dose or bolus dose is set.
  • the pump is capable of performing in several different modes including (a) PCA only wherein a drug is administered only in response to a request from a patient, (b) basal only, wherein the patient receives the drug continuously at a preselected rate and may not request an additional dosage and (c) PCA and basal wherein the patient receives the drug continuously at a preselected rate, however if he so desires, he may request additional PCA doses.
  • PCA PCA only wherein a drug is administered only in response to a request from a patient
  • basal only wherein the patient receives the drug continuously at a preselected rate and may not request an additional dosage
  • PCA and basal wherein the patient receives the drug continuously at a preselected rate
  • Yet a further objective is to provide a pump with separate non-volatile memory means for storing configuration information whereby the pump need not be reconfigured every time it loses power.
  • This invention consists of a an infusion pump assembly and a technique by which capabilities can be added to an infusion pump without making programming the pump for each use more complicated, and without adding any sort of cartridge.
  • Infusion pumps designed using this invention are exceedingly flexible, capable of performing a wide riety of different drug infusion therapies.
  • Ye'. _hey are as easy and safe to use as if they were designed for a specific protocol and regimen.
  • This pump assembly includes an electrically alterable non-volatile memory device connected to a central processing unit (CPU) .
  • the CPU can read the contents of this memory and these contents may be changed under control of the pump assembly software. If there is no software request for the change of this memory, the contents are maintained indefinitely.
  • This non-volatile memory is preferably of the variety known as EEPROM or
  • EEPROM Electrically Erasable and Programmable Read Only Memory.
  • This EEPROM is typically contained in an integrated circuit package located on a printed circuit board inside the pump assembly housing. However, it may also be contained inside of a microprocessor or microcontroller used in the pump assembly. EEPROM is preferred for the non-volatile memory component since it does not require any sort of battery backup to maintain its contents.
  • the term non-volatile memory in this instance, is intended to indicate that the memory's contents are maintained independent of the status of the system's primary power source. In the case of a battery operated infusion pump, the non-volatile memory's contends are maintained whether or not a primary battery is inserted or removed.
  • Alternate configurations could include secondary-battery backup of a Static RAM (Random Access Memory) .
  • the techniques required for implementing this invention are incorporated into the software that controls the pump, and would have several parts: i) Configuration Access Protectiony ii) The Pump Configuration Selection Routines iii) The Default Configuration iv) The Configuration Reading Routines v) The Configuration Interpretation Routines vi) The Configuration Writing Routines vii) Configuration Safety Routines
  • a user who uses the pump assembly in only one particular configuration does not necessarily need to be made aware of how the configuration of the pump assembly is changed.
  • a hospital's biomedical engineering department may be made responsible for setting and verifying proper pump configuration and the nurses in a particular hospital unit may always use the pumps with one particular configuration.
  • a hospital's protocol may even require that the configuration only be carried out by authorized personnel.
  • routines are provided that restrict access to the configuration changing routines.
  • this routine requires a special sequence of key presses that must be used to access the configuration changing routine.
  • the sequence of key presses is such that it does not occur during normal operation of the pump assembly.
  • the sequence may include holding down several keys simultaneously and/or pressing several keys in a particular order, optionally with a time limit.
  • the CPU When the pump is first turned on, the CPU reads in the selected configuration.
  • the software routines that perform this task access the non ⁇ volatile memory component, and then read its contents. These contents contain coded information corresponding to a desired configuration of the pump. This information would be decoded by the Configuration Interpretation Routines.
  • the CPU accesses the non-volatile memory component and writes coded information to it that specifies the configuration. This information remains there until the next time the Configuration Selection Routines are activated. The coded information is read back using the Configuration Reading Routines.
  • routines verify proper operation of the configuration circuit and the software routines that use it.
  • error checking information would be written also. When the configuration information is read back this error checking information would be used to ensure that no failures have occurred in the circuit or the software routines.
  • the configuration information may also be subject to a "reasonableness" check. This would simply involve making sure that the configuration selected is possible.
  • a typical implementation of the error checking information scheme involves writing the coded configuration information to the non-volatile memory component along with the two's complement of the information. A checksum could also be written for further verification.
  • a typical implementation of the reasonableness check scheme involves ensuring that configuration selections fall within selectable bounds. For example, if a device was configured so that a maximum dose volume is selected, that maximum dose volume setting is verified to ensure that if falls within the range of possible maximum dose volumes.
  • FIG. 2 shows a block diagram of a pump assembly constructed in accordance with this invention
  • Figure 3 shows a flow chart for a program for the pump assembly of Figure 2 for selecting its mode of operation
  • Figure 4 shows a flow chart for a program for setting up the pump assembly of Figure 2 after a specific mode has been configured.
  • an infusion pump assembly 10 constructed in accordance with this invention includes a pump 12 connected to a bag, syringe, or other drug container means 14 by a tube 16.
  • the pump 12 is used to dispense a drug from bag 14 to a patient through a tube 18.
  • Tube 18 may be an IV tube used to feed the drug to a patient intravenously, it may be connected to an epidural catheter, and so on.
  • the pump 12 is operated by a microprocessor 20 through a pump control interface 22.
  • the power supply 36 provides this power selectively from a standard AC line, one or more rechargeable batteries, or one or more disposable batteries. Details of this power supply may be found in U.S. application S.N. 778,557 filed October 18, 1991, entitled INFUSION PUMPS WITH BATTERY BACK-UP and commonly assigned with the present application. All these components may be disposed in a common housing 40.
  • the basic programming of the microprocessor 20 is located in the standard ROM 32. If no changes are made in the configuration of the microprocessor 20, the program follows the steps initializing program or state outlined in Figure l. ROM 32 also contains initial parameters for the operation of the pump set in the factory. These parameters are provided as default values in case a clinician fails to set these parameters correctly, or as a means of providing guide values if the EEPROM 34 fails and needs to be replaced or reprogrammed.
  • this pump may be first reconfigured in a mode selection state to a mode compatible with the hospital protocol, and/or for a designated usage. For example, a hospital may decide to use a particular pump in a basal only mode. In order to configure the pumps to this mode, first the microprocessor is entered into a pump configuration subroutine 16
  • step 160 the bolus limit is set for the initial dosage required to bring the level of the prescribed drug in the patient to a desired value.
  • the parameters and limits selected in steps 152-160 are stored.
  • these parameters and limits are stored in EEPROM 34 as discussed above.
  • the pump assembly 10 is not reconfigured, it operates in accordance with the program flow chart of Figure 1. However, once the pump assembly 10 has been reconfigured, its original program is modified so that it operates in the selected mode. Of course, the pump must still be set up for operation during a set up stage. However, as illustrated below, since the mode and limits of the pump have been already selected, the set up of the pump system of Figure 2 is easier to learn and less confusing than the set up of Figure 1.
  • step 152 the clinician has selected the BASAL mode
  • the pump system 10 is set up as shown in Figure 4 using the following steps. As soon as the pump system is energized, the contents of the EEPROM 34 are loaded into the RAM
  • step 202 a security code is requested. This step is still required to prevent tampering.
  • the security code may be stored now in the EEPROM 34.
  • step 204 the volume of drug in bag 14 is specified.
  • step 206 the pump is primed to remove air bubbles from the system.
  • step 208 the concentration of the drug 15 consisting of a mode-selection sequence state. This may be accomplished for example by pressing several keys on key pad 26 in a preselected order. Preferably, the keys and order are selected to avoid a sequence which would occur under normal operation of the pump.
  • the icr processor 20 shows prompts on display 24 necessary for reconfiguring the pump assembly.
  • the factory preset value of the pertinent parameter is shown on display 24. More specifically, as shown in Figure 3, after the proper mode selection sequence of keys have been activated (step 150) , the desired mode of operation is requested in step 152. For example, during this step, the clinician indicates whether the pump is to operate in a PCA ONLY, BASAL ONLY or PCA and BASAL mode. In the next step 154 the clinician is requested to enter the concentration or units of measurement to be used. Once this selection is made the microprocessor will display all devices of units (i.e. ml, mg, meg, etc) .
  • step 156 the clinician is requested to enter the limits for the basal administration. That is, the clinician is asked to set the maximum limit for the continuous administration rate of the drug. If the PCA ONLY mode is selected in step 152 then step 156 is skipped.
  • step 158 the clinician is asked for the limits of the PCA administration, i.e. the PCA dosage and the PCA delay (the minimum time period between allowable PCA dosages) . If the BASAL ONLY mode is selected in step 152 then step 158 is skipped. in the bag is requested in the preset units. In step 214 the basal rate is set. Finally in step 218 the bolus is set.
  • the initializing pre ram has been broken up into two stages: a presetting stage during which the pump is configured to a particular mode, and operational limits are selected, and a setup stage during which the actual operational parameters are selected.
  • the pump assembly is set up so that persons having higher levels of security and technical expertise can select the pump mode while persons requiring less skills can set up the pump assembly.
  • the novel features of this invention include: i) The use of a non-volatile memory device with associated software routines for the purpose of customizing the user interface of a complex drug infusion device. Included in this would be the use of a default configuration and user selectable alternate configurations. Pumps using this invention would be unique in that once they are programmed according to a particular user group's standard protocols, they would act as if they were a device designed specifically for that application or protocol. This would greatly enhance the user- friendliness of the device, and would minimize the risk of programming errors. ii) Another novel feature of this invention is that it will allow the design of drug infusion pumps that are multi-purpose.
  • PCA Patient Controlled Analgesia
  • intermittent antibiotic administration For example, in the past a hospital would have to purchase separate devices for chemotherapy administration, Patient Controlled Analgesia (PCA) administration, or intermittent antibiotic administration. With the introduction of this configuration capability, a single pump will be capable of being configured in a chemotherapy mode, a PCA mode or an intermittent mode. This would have been less desirable in the past due to the great complexity of the user interface that would have been required.
  • this invention can be used to enhance patient safety by allowing each hospital to program limits on each prescription item. These prescription limits could be tailored to the way each hospital uses its pumps. Programmable prescription limits would also enhance the flexibility of the device since the limits could be changed to adapt to new drug dosing regimens as they are developed.
  • patient safety will be enhanced because the the pump can be configured to operate only in a specific mode. For example, continuous infusion could be disabled by configuration to prevent accidental programming of an unwanted continuous infusion.
  • This invention is a vast improvement over the standard practice of using a complex user interface to program infusion pumps.
  • the simplifications of user-interface attained by the use of this invention will enhance the desirability of infusion pumps by providing devices that are much easier to use than those available today.
  • the pumps designed using this technique will also be safer since the customized user interfaces will reduce the risk of programming errors.
  • This approach is also of much lower cost than such other approaches as mechanical switches, "smart” labels, or insertable cartridges or cassettes. This approach also uses much less space inside the device than these other approaches. This is important since the devices involved are usually small and portable. Finally, this approach will typically consume less power than these approaches since the configuration circuit would only be activated briefly at power up and a similar amount of time if and when it is updated. This is important since these devices are typically battery operated.

Abstract

On peut configurer une pompe (10) de perfusion programmable afin qu'elle fonctionne dans l'un d'une pluralité de modes de fonctionnement (c'est-à-dire BASAL, PCA, BASAL et PCA, etc.). La pompe (10) est dotée d'une mémoire (34) effaçable de préférence non rémanente, destinée à conserver des informations désignant un des modes. L'utilisateur final peut installer la pompe (10) facilement et rapidement pour le mode désigné, puisque les autres modes non désignés sont rendus invisibles.
EP19930914317 1992-05-26 1993-05-21 Plan de configuration de pompe de perfusion utiisant des memoires eeprom. Withdrawn EP0620940A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US88851892A 1992-05-26 1992-05-26
US888518 1992-05-26
PCT/US1993/005232 WO1993024893A1 (fr) 1992-05-26 1993-05-21 Plan de configuration de pompe de perfusion utiisant des memoires eeprom

Publications (2)

Publication Number Publication Date
EP0620940A1 true EP0620940A1 (fr) 1994-10-26
EP0620940A4 EP0620940A4 (fr) 1994-12-07

Family

ID=25393319

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19930914317 Withdrawn EP0620940A4 (fr) 1992-05-26 1993-05-21 Plan de configuration de pompe de perfusion utiisant des memoires eeprom.

Country Status (5)

Country Link
EP (1) EP0620940A4 (fr)
JP (1) JPH06509265A (fr)
AU (1) AU660826B2 (fr)
CA (1) CA2113905A1 (fr)
WO (1) WO1993024893A1 (fr)

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US5609575A (en) * 1994-04-11 1997-03-11 Graseby Medical Limited Infusion pump and method with dose-rate calculation
US7074205B1 (en) 1995-03-13 2006-07-11 Cardinal Health 303, Inc. Method and apparatus for power connection in a modular patient care system
US7384410B2 (en) 1995-03-13 2008-06-10 Cardinal Health 303, Inc. System and method for managing patient care
US5782805A (en) * 1996-04-10 1998-07-21 Meinzer; Randolph Medical infusion pump
US20060009734A1 (en) * 2004-07-07 2006-01-12 Martin James F Dosage control for drug delivery system

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EP0503670A2 (fr) * 1991-03-14 1992-09-16 Sharp Kabushiki Kaisha Pompe d'infusion intraveineuse peristaltique capable d'afficher le nom de l'application sélectionnée

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Title
See also references of WO9324893A1 *

Also Published As

Publication number Publication date
WO1993024893A1 (fr) 1993-12-09
AU660826B2 (en) 1995-07-06
CA2113905A1 (fr) 1993-12-09
EP0620940A4 (fr) 1994-12-07
AU4402393A (en) 1993-12-30
JPH06509265A (ja) 1994-10-20

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