EP0671959B1 - Apparatus for preparing intravenous anesthesia infusions - Google Patents

Apparatus for preparing intravenous anesthesia infusions Download PDF

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Publication number
EP0671959B1
EP0671959B1 EP93900905A EP93900905A EP0671959B1 EP 0671959 B1 EP0671959 B1 EP 0671959B1 EP 93900905 A EP93900905 A EP 93900905A EP 93900905 A EP93900905 A EP 93900905A EP 0671959 B1 EP0671959 B1 EP 0671959B1
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EP
European Patent Office
Prior art keywords
drug
infusion
rate
concentration
mix
Prior art date
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Expired - Lifetime
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EP93900905A
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German (de)
English (en)
French (fr)
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EP0671959A1 (en
EP0671959A4 (da
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Edward Teeple, Jr.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions

Definitions

  • the present invention relates to a method and apparatus for preparing solutions of drugs for continuous infusion to a patient, and especially to an improved, cost effective and reliable method and apparatus for use by qualified physicians in which the amount of drug required is determined on the basis of a standardized infusion rate.
  • intravenous agents can be used in the treatment of medical patients, such as general anesthesia or an inhalational anesthetic supplements; neuromuscular blockers and paralysis drugs; cardioresuscitative drugs for critical care applications; and many others.
  • anesthesiologists often employ one or more drugs for continuous infusion techniques.
  • this practice may be cumbersome and difficult because of the large number of variables involved and the difficulty of remembering each important factor involved in administering one or a combination of drugs.
  • practitioners often choose to administer one or two agents only and memorize the requirements related to those specific agents and-or standardize a drug mix and vary the delivery rate for each patient, all in hopes of reducing the possibility of error.
  • This equation includes five “unknowns” (the “C” comprising two variables: the numerator (weight in mg) and the denominator (volume in ml)), requiring that a series of calculations be performed each time a drug mix is prepared and used. These intricate calculations make application of the infusion techniques laborious, and increase the risk of human error. The pressures of providing critical health care, coupled with the long and late hours worked by care providers, make desirable any method that reduces the potential for error.
  • US-A-4,853,521 discloses a system for verifying and recording drug administration to a patient, including computerized system to run delivery.
  • US-A-4,058,120 discloses a vaporizer carousel for anesthesia machine.
  • US-A-4,246,894 and 4,334,526 disclose a method and system for administering a dissociative unconscious type of anesthesia.
  • US-A-5,015,781 discloses an Anesthetic compound and method of preparation.
  • US-A-4,917,670 discloses a continuous spinal anesthesia administering apparatus and method.
  • US-A-4,825,860 discloses a device for supplying anesthetic dispensing systems.
  • US-A-4,053,604 discloses a method for improving anesthesia mixtures and compositions.
  • US-A-5 040 699 discloses a method and apparatus for providing anesthesia according to the preambles of claims 1 and 8 respectively.
  • Infusion pumps are also well-known, although the expense of these devices can be prohibitive in many clinical settings. See “Infusion Pumps,” Milestones in Anesthesia, pp.2-3.
  • the present invention generally refers to a method and apparatus for preparing a drug solution for continuous infusion which is capable of executing the following steps: establishing a standardized dosage rate; establishing a standardized rate of infusion; and determining the required concentration of the drug on the basis of the weight of the patient, the standardized dosage rate and the standardized rate of infusion.
  • these steps are repeated for a number of drugs at incremental weights to establish a reference table of required concentrations.
  • the concentrations are preferably determined on a per unit milliliter basis to enable easy determination of the amount of the drug to be added to the infusion bag.
  • the standardized dosage rate is preferably the maximum maintenance infusion rate established for that drug.
  • Anesthesia as prepared according to the present invention is induced according to standard anesthetic techniques.
  • An appropriate loading dose is administered to induce anesthesia; following induction, the maintenance infusion is started and maintained.
  • Anesthetic requirements vary, according to the operative procedure to be performed, the health and condition of the patient, the length of the procedure, and numerous other factors. (See Table 1.)
  • a standardized infusion rate of 30 ml ⁇ hr -1 is used as a standard to deliver a high (or "maximum") infusion dosage. If the continuous infusion drug is intended to be a supplemental anesthetic agent, the infusion rate should be decreased accordingly.
  • Figure 1 shows that at 30 ml ⁇ hr -1 , all drugs are being delivered at the high rate. Figure 1 eases the interpretation of low to high rates for ten relevant anesthesia drugs.
  • the method and apparatus of the present invention offers a number of benefits over other methods of mixing anesthesia.
  • Prior methods require physicians to calculate the doses they are giving according to a cumbersome formula. Because patients has different body weights, drug solution flow rates will necessarily vary accordingly. It thus becomes very difficult during clinical use to be recalculating how much drug the patient is receiving all the time.
  • the use of this method due to its standard delivery of the maximum rate (generally 30 ml-hr) makes dosage interpretation much easier for the physician and much safer for the patient.
  • the use of the present method allows the use of simple, less expensive infusion pumps that are already commonly used if not already available in the clinical setting. Hence, there are also significant cost benefits to the application of the method of the present invention in the operating room or virtually any clinical setting.
  • Anesthesia and other drugs to be administered according to the present invention may be prepared from vials with premeasured doses, for patients within a specified weight range to eliminate mixing steps that would otherwise be necessary, thereby reducing the risk of human error.
  • the present method is also useful for administering a broad range of drugs, including muscle relaxants, sedatives and analgesics.
  • This infusion method can again be used both in the operating room and in the intensive care unit pharmacy, outpatient medical and dental facilities, or any number of clinical situations.
  • the present method is applicable to a variety of types of drugs, including, but not limited to, anesthetics, muscle relaxants, sedatives, analgesics and cardioresuscitative drugs.
  • the method of the present invention offers a number of benefits over prior methods of mixing such drugs.
  • the present method because of standardization of the dosage rate, makes interpretation much easier for the physician and much safer for the patient.
  • the present method also allows the use of simpler and much less expensive infusion pumps that are already easily available in the clinical setting. The method is equally useful in the operating room, intensive care unit, or elsewhere in the hospital environment.
  • Premeasured vials of drug concentrate may be bar coded or otherwise encoded with a machine readable data set (drug type, freshness date, concentration, volume, etc.) so as to insure that the proper drug mix is achieved, reducing if not eliminating the possibility for human error.
  • the present method also allows greater flexibility in selection of an agent to use for a continuous infusion anesthetic or analgesic. Physicians relieved of the difficulties of prior methods of preparing anesthetics will be encouraged to widen the number of and types of drugs they use for continuous infusions. Physicians are thus able to use the best combinations of drugs with reduced risk of inappropriate dosing.
  • MIR Maintenance Infusion Rates
  • D will equal MIR-High level for each agent.
  • Body Weight (B.W.)
  • Body weight is a fixed value for each individual patient. In the table used here, a column of values will be created for each 10 kg increase in weight.
  • the constant 0.06 corrects for unit of measurement differences between the dosage and the infusion rate (ml-hr).
  • rate of infusion can be any selected value. However, to simplify and standardize the infusion rates for all the intravenous agents, the rate will be set at 30 ml ⁇ hr -1 . (1) This standardization of the high-MIR dosage with a rate of delivery will make the application of all intravenous infusion anesthetics consistent.
  • the concentration of the infusion mixture is given in mg-ml. This term will be referred to hence forth as the Concentration Multiplier (C*).
  • C* Concentration Multiplier
  • Table 2 is generated. Selection of, 1) the desired intravenous agent by row, and 2) the kg weight of the patient by column, allows the practitioner to choose C*.
  • C* equals the number of mg per ml of dilute in the infusion bag. This mixture will deliver the MIR high if the infusion pump is set to deliver 30 ml per hour.
  • the actual loading dose will be determined by the clinician based on the clinical status of the individual patient.
  • Anesthesia will be induced according to standard anesthetic technique.
  • the appropriate loading dose will be given to induce anesthesia.
  • the maintenance infusion will be started.
  • the infusion rate of 30 ml ⁇ hr -1 is selected to deliver the high MIR recommended in White's article. If the continuous infusion drug is intended to be a supplemental anesthetic agent, the infusion rate should be decreased accordingly.
  • Figure 4 shows the high-low delivery rates which reflect the values given in White (Table 4). Keeping the flow rates within the checkered area will deliver the recommended dosage levels. Figure 4 allows the practitioner to visually evaluate where the infusion falls in the rank of the selected high-low maintenance infusion rates.
  • the MIR should be serially lowered to maintain the lowest tolerable infusion rate. This will allow for quicker patient wake up at the end of the procedure.
  • the loading dose determination is as follows:
  • the selected loading dose will be given as an immediate intravenous premedication or as part of the anesthetic induction.
  • continuous infusion of Fentanyl will be started at 15 ml-hr. (See Figure 4.)
  • the infusion rate will be titrated to effect using the guidelines suggested in Figure 4 of White.
  • Figure 1 shows a sample computer screen output and-or final mixed bag label listing the mixing determination.
  • the computer is programmed according to the method outlined above, so that upon input by the user of the requisite data under the method, the program executes the steps of dosage determination for the operator.
  • the results of the dosage determination may preferably be printed out an adhesive-backed label for manual or automatic attachment to the final mixed bag.
  • Figure 2 shows the layout for a computerized mix controller 20 for preparing drug mixes.
  • the computerized mix controller is capable of performing the mixing determination, and then mixing drugs from drug matrix 24 through supply lines 21 (controlled by multiport drug concentration valve 22) and diluent from vessel 25 (controlled by diluent valve 26) so as to mix the infusion bag 27 for the practitioner.
  • Computer 23 is preprogrammed according to the method of the present invention so that upon input by the user of the requisite variables, and execution of the appropriate command, the device completes the steps of dosage determination, infusion bag mixing and labeling (as output by automatic label maker 28) for the operator.
  • Computer 23 may also be equipped with an alarm capable of alerting the operator of system malfunction, insufficient quantities of diluent or drug concentrate, program error and/or improper data entry.
  • the results of the dosage determination are printed out by label maker 28 for attachment to the final mixed bag.
  • the computerized mix controller is equipped with a flow meter-valve system so that upon input of the appropriate command, the necessary diluent dispensed into the supply bag.
  • the necessary drug concentrates are thereafter dispensed from individual vessels into the supply bag, again using a valve, flow meter or carousel and valve setup.
  • this bag may be manually or automatically sealed, and an adhesive-backed label with the final mix information may be manually or automatically affixed to the bag.
  • the apparatus of the present invention permits a single device to prepare infusion bags at a rapid rate for an entire medical complex or even multiple facilities.
  • a hand held, lap-top or desktop computer may be used by the practitioner at each patient infusion site, or again at a centralized location.
  • the drug concentrates may most desirably be stored in a temperature-controlled environment prior to use; the infusion bag may after mixing likewise be maintained in this controlled environment.
  • the computer program is also desirably equipped with a shelf-life monitoring function; when the shelf-life of a drug expires, the operator may be notified, or a fresh drug concentrate vial may automatically be moved into place, and the expired vial automatically disposed of.
  • a bar code reader system may be used to monitor expiration date, and to monitor that the correct drug concentrate has been loaded into the automatic mix controller.
  • Figure 3 shows a device 30 for preparing drug mixes.
  • Drug concentrate vials 31, 32 and 33 are inserted into receptacles 35, 36 and 37.
  • Computer terminal 38 is preprogrammed according to the method of the present invention so that upon input by the user of the requisite variables, and execution of the appropriate command, the device completes the steps of dosage determination and infusion bag mixing for the operator. The results of the dosage determination may again be printed out for attachment to the final mixed bag.
  • a fluid connector 40 on each drug concentrate vial permits the drug from each vial to be measure by a valve or flow meter and thereafter pumped or drained through supply line 46 into mixed bag 47.
  • a bar code reader 41 monitors the drug type and expiration date of the drug in each drug concentrate vial, as indicated by bar code 42 on each vial. If an incorrect drug concentrate has been loaded into the automatic mix controller 48, or the drug is no longer fresh, an alarm may sound, and-or the device may automatically disable to prevent an incorrect or stale drug from being dispensed.
  • Diluent supply 45 provides the required diluent for the final mixed bag 47.
  • Label maker 49 may manually or automatically apply an adhesive-backed data label to the final mixed bag.
  • the computer is preprogrammed according to the method of the present invention so that upon input by the user of the requisite variables, and execution of the appropriate command, the device completes the steps of dosage determination and infusion bag mixing for the operator.
  • the results of the dosage determination (including all information displayed on the screen shown in Figure 1) may again be printed out for attachment to the final mixed bag.
  • the method and apparatus of the present invention standardizes and simplifies use of continuous intravenous infusion anesthesia and analgesia. Institutions that would rigorously apply the suggested mixes would standardize all infusion rates for all the listed drugs.
  • total dose Most practitioners are more comfortable evaluating drug usage under the "total dose” concept. Using this concept, the C* (see Table 2) selected (mg-ml) times (total ml's given) will equal total dose. This can perhaps best be visualized by the similar vaporizer/percent delivery concept.
  • a desirable method and important advancement in the pharmaceutical delivery industry included in the present invention is the use of premeasured (and standardized) vials of anesthetic drugs, with bar coded data labels. These vials should desirably coincide with the parameters set forth in Table 1. This allows standardized and easier mixing of the drugs for the practitioner. This would again increase safety due to the fact that the drug amounts would be determined by the manufacturer.
  • an apparatus computer, or the like
  • that apparatus may be coupled with a printer to output a label to be attached to the anesthesia bag.
  • an automated mixing system to prepare the drug solutions using the premixed vials or similar method of calibrating the required volumes/weights of drugs and dilute to be used in a drug delivery bag.
  • the method of the present invention can be tailored according to the described formulations to meet specific desired performance characteristics for a wide variety of intravenous drug applications.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nutrition Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
EP93900905A 1991-12-06 1992-12-07 Apparatus for preparing intravenous anesthesia infusions Expired - Lifetime EP0671959B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US80296391A 1991-12-06 1991-12-06
PCT/US1992/010521 WO1993010851A1 (en) 1991-12-06 1992-12-07 Method, apparatus for preparing and administering intravenous anesthesia infusions

Publications (3)

Publication Number Publication Date
EP0671959A1 EP0671959A1 (en) 1995-09-20
EP0671959A4 EP0671959A4 (da) 1995-10-25
EP0671959B1 true EP0671959B1 (en) 2002-04-24

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EP93900905A Expired - Lifetime EP0671959B1 (en) 1991-12-06 1992-12-07 Apparatus for preparing intravenous anesthesia infusions

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EP (1) EP0671959B1 (da)
AT (1) ATE216610T1 (da)
AU (1) AU3241393A (da)
CA (1) CA2126556C (da)
DE (1) DE69232578D1 (da)
DK (1) DK0671959T3 (da)
ES (1) ES2173091T3 (da)
PT (1) PT671959E (da)
WO (1) WO1993010851A1 (da)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5807316A (en) * 1991-12-06 1998-09-15 Teeple, Jr.; Edward Method and apparatus for preparing and administering intravenous anesthesia infusions
US8095379B2 (en) * 2003-12-30 2012-01-10 Cerner Innovation, Inc. System and method for preemptive determination of the potential for an atypical clinical event related to the administering of medication
US20220379024A1 (en) * 2019-11-08 2022-12-01 Bristol-Myers Squibb Company System for interrogating serially-connected drug modules in a combinatorial drug delivery device

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3800794A (en) * 1970-12-30 1974-04-02 Ivac Corp Method and apparatus for fluid flow control
US4155362A (en) * 1976-01-26 1979-05-22 Baxter Travenol Laboratories, Inc. Method and apparatus for metered infusion of fluids
US4128145A (en) * 1977-08-31 1978-12-05 Lambert Brake Corporation Combination failsafe brake and one-way clutch
US4335835A (en) * 1978-12-26 1982-06-22 Anatros Corporation Device for the intravenous or enteric infusion of liquids into the human body at a predetermined constant rate
US4740198A (en) * 1981-10-09 1988-04-26 Alza Corporation Method of administering intravenous drug using rate-controlled dosage form
US4715850A (en) * 1984-12-06 1987-12-29 Controlled Release Technologies, Inc. Therapeutic agent delivery system and method
US4822339A (en) * 1984-12-06 1989-04-18 Controlled Release Technologies, Inc. Therapeutic agent delivery system and method
US4822344A (en) * 1986-12-05 1989-04-18 Sta-Set Corp. Apparatus for controlling fluid flow rate
US5041086A (en) * 1987-12-04 1991-08-20 Pacesetter Infusion, Ltd. Clinical configuration of multimode medication infusion system
US4853521A (en) * 1987-12-28 1989-08-01 Claeys Ronald W System for verifying and recording drug administration to a patient
US4917670A (en) * 1988-03-22 1990-04-17 Hurley Ronald J Continuous spinal anesthesia administering apparatus and method
US4969871A (en) * 1989-02-15 1990-11-13 Alza Corporation Intravenous system for delivering a beneficial agent
US5040699A (en) * 1989-05-15 1991-08-20 Gangemi Ronald J Fluid compounding method and apparatus
US5116316A (en) * 1991-02-25 1992-05-26 Baxter International Inc. Automatic in-line reconstitution system

Also Published As

Publication number Publication date
WO1993010851A1 (en) 1993-06-10
ATE216610T1 (de) 2002-05-15
DK0671959T3 (da) 2002-06-17
AU3241393A (en) 1993-06-28
ES2173091T3 (es) 2002-10-16
EP0671959A1 (en) 1995-09-20
DE69232578D1 (de) 2002-05-29
PT671959E (pt) 2002-08-30
EP0671959A4 (da) 1995-10-25
CA2126556A1 (en) 1993-06-10
CA2126556C (en) 2000-01-11

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