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US20060009734A1 - Dosage control for drug delivery system - Google Patents

Dosage control for drug delivery system Download PDF

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Publication number
US20060009734A1
US20060009734A1 US10/886,255 US88625504A US2006009734A1 US 20060009734 A1 US20060009734 A1 US 20060009734A1 US 88625504 A US88625504 A US 88625504A US 2006009734 A1 US2006009734 A1 US 2006009734A1
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Prior art keywords
loading dose
maintenance rate
patient
drug
level
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Abandoned
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US10/886,255
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English (en)
Inventor
James Martin
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to US10/886,255 priority Critical patent/US20060009734A1/en
Assigned to ETHICON ENDO-SURGERY, INC. reassignment ETHICON ENDO-SURGERY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MARTIN, JAMES F.
Priority to PCT/US2005/020149 priority patent/WO2006016952A2/fr
Priority to NZ601704A priority patent/NZ601704A/xx
Priority to CA2572994A priority patent/CA2572994C/fr
Priority to MX2007000351A priority patent/MX2007000351A/es
Priority to KR1020077003001A priority patent/KR101298508B1/ko
Priority to CN200580027258XA priority patent/CN101001662B/zh
Priority to BRPI0511447-0A priority patent/BRPI0511447A/pt
Priority to AU2005272122A priority patent/AU2005272122B2/en
Priority to JP2007520311A priority patent/JP4980214B2/ja
Priority to EP05757429A priority patent/EP1781367A4/fr
Priority to TW094122771A priority patent/TWI445560B/zh
Publication of US20060009734A1 publication Critical patent/US20060009734A1/en
Priority to CR8910A priority patent/CR8910A/es
Priority to US11/695,775 priority patent/US20070191817A1/en
Priority to US13/038,841 priority patent/US8622989B2/en
Abandoned legal-status Critical Current

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    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • 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
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • 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
    • A61M5/1723—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 using feedback of body parameters, e.g. blood-sugar, pressure

Definitions

  • the present invention relates generally to drug delivery systems, and more particularly to a method of calculating a drug infusion profile for a drug delivery system. While the invention can be used in administering a variety of intravenous drugs it is particularly useful as an anesthetic delivery system.
  • Three conditions or objectives control the administration of an anesthetic, namely, to rapidly produce the desired pharmacologic effect (hypnosis, analgesia, etc.); to maintain the desired effect throughout the medical procedure; and to enable the patient to recover quickly from the effect following completion of the procedure.
  • an anesthetic namely, to rapidly produce the desired pharmacologic effect (hypnosis, analgesia, etc.); to maintain the desired effect throughout the medical procedure; and to enable the patient to recover quickly from the effect following completion of the procedure.
  • a Loading Dose is a bolus (mg/kg, mg, etc.) of drug that rapidly brings the patient to a desired level of effect.
  • a Maintenance Rate is a constant infusion rate ( ⁇ g/kg/min, mg/min, etc.) required to maintain the patient at a certain target, in this embodiment anesthetic, effect.
  • the anesthesiologist may have to titrate this Maintenance Rate during the procedure as the patient's anesthetic needs change.
  • a method that allows for rapidly adjusting the patient's level of effect is desired.
  • the anesthesiologist attempts to deliver as little drug as needed. This can include tapering down the Maintenance Rate prior to the end of the procedure.
  • anesthesia is used herein to refer to the continuum of hypnosis and analgesia, achieved via anesthetic drugs, from anxiolysis through general anesthesia.
  • conscious sedation as practiced by endoscopists, the anesthetic(s) is typically delivered through frequent boluses. This technique results in varying depths of anesthesia throughout the procedure. At times the patient may be so heavily anesthetized as to be classified in general anesthesia. At other times the patient may be under-anesthetized and exhibit pain and agitation. A patient responding to pain is uncooperative, making the procedure more difficult. As a result, the clinician tends to err on the over-anesthetized side.
  • over-anesthetizing causes the patient's recovery from anesthesia to be much longer. Accordingly, a method is desired that enables the clinician to control the level of anesthesia without over- or under-anesthetizing the patient.
  • sedation drug is used herein to refer to the classes of drugs employed by anesthesiologists in inducing sedation including hypnotics and analgesics.
  • Propofol and remifentanil are preferred drugs for sedation, principally due to their rapid onset and offset.
  • this rapid action presents additional concerns for someone using an intermittent bolus technique, as typically done by non-anesthesiologists. With a rapid onset/offset more frequent boluses will be required. Consequently, anesthesiologists often use infusion pumps to continuously deliver these rapid action sedation drugs.
  • Anesthetic Delivery System is intended to enable a non-anesthesiologist to safely and effectively use these rapid action anesthetic agents typically reserved for use by anesthesiologists.
  • What is desired is an algorithm that will allow the clinician to program an ADS with a desired maintenance rate, selected by the clinician to maintain a desired level of anesthesia, and then the ADS automatically calculates the appropriate sized loading dose based on the pharmacokinetics of the chosen sedation drug.
  • the loading dose is then delivered by the ADS to rapidly achieve the level of sedation, immediately followed by a constant infusion of the sedation drug at the maintenance rate, to maintain the level of anesthesia.
  • a method is desired where the patient's level of anesthesia is rapidly adjusted, each time the clinician changes the maintenance rate, in response to the patient's changing anesthetic needs.
  • an ADS that integrates the initiation and maintenance of anesthesia in an equation so that the appropriate sized loading dose may be calculated and administered to rapidly bring the patient's depth of anesthesia to a level maintained by the programmed maintenance rate. Further, when a change in the maintenance rate is requested, the dosage controller (DC) can calculate an incremental loading dose to rapidly achieve the new level of anesthesia.
  • the invention provides a method of drug infusion for maintaining or rapidly adjusting a patient's level of anesthesia comprising programming an automated drug delivery system with a maintenance rate (MR); causing the drug delivery system to calculate the loading dose (LD) using a formula that relates loading dose and maintenance rate; the drug delivery system infusing the loading dose into patient to achieve a desired level of anesthesia and administering the drug at the maintenance rate to maintain the level of anesthesia.
  • MR maintenance rate
  • LD loading dose
  • the invention provides a method of drug infusion for maintaining or rapidly adjusting a patient's level of anesthesia comprising the clinician programming an automated drug delivery system with a loading dose (LD); causing the drug delivery system to calculate the maintenance rate (MR) using a formula that relates loading dose and maintenance rate; the drug delivery system infusing the loading dose into the patient to achieve a level of anesthesia and administering the drug at the maintenance rate to maintain the level of anesthesia.
  • LD loading dose
  • MR maintenance rate
  • the level of anesthesia is rapidly adjusted when the clinician programs a new maintenance rate, by a method that further comprises: calculating the cumulative loading dose based on the drug already administered to the patient; calculating a new loading dose based on the cumulative loading dose and a new maintenance rate based on a formula relating loading dose and maintenance rate; the ADS infusing the new loading dose into patient to achieve the new level of anesthesia and the administering the drug at the desired new maintenance rate to maintain the new level of anesthesia.
  • Still a further embodiment is a drug delivery system that includes an infusion pump and a controller and is programmed to control infusion as described herein.
  • the system includes sensors for monitoring patient physiology and can be programmed to discontinue administering the drug if adverse physiology or trends are detected.
  • FIG. 1 is a drawing of the Automated Response System (ARM) utilized in an embodiment of the invention.
  • ARM Automated Response System
  • FIG. 2 is a collection of flow charts ( FIGS. 2A-2F ) for a DC program useful in accordance with an embodiment of the invention.
  • FIGS. 3 and 4 are graphs illustrating the determination of a ramped infusion rate for a loading dose that culminates in the maintenance rate.
  • the invention is explained using the delivery of propofol to achieve and maintain a level of anesthesia referred to as conscious sedation.
  • conscious sedation a level of anesthesia
  • the invention can be applied to any intravenous drug where it is appropriate to deliver a loading dose followed by a maintenance infusion.
  • the equations will be adjusted for different pharmacokinetics (loading dose/maintenance rate relationships) for these other drugs.
  • classes of drugs in addition to sedation drugs that can be administered in accordance with the invention are antibiotics, pain management drugs, cardiovascular drugs, anticancer drugs, and others.
  • An anesthetic drug such as propofol provides labeling recommendations for initiating sedation (loading dose)—0.0 to 0.5 mg/kg, and infusion rates for maintaining the patient's level of sedation (maintenance rate)—0.0 to 75 ⁇ g/kg/min.
  • the clinician may select a maintenance rate corresponding to the level of anesthesia he desires to achieve, e.g., ASA guidelines are drafted in terms of mild, moderate and deep anesthesia and based on the ratio of that maintenance rate to the maximum maintenance rate recommended for that application of the drug, a loading dose is determined.
  • the equation relating loading dose to maintenance rate will represent a linear proportion or interpolation based on the loading dose and maintenance rate ranges suggested by the supplier and still more specifically based on the maximum loading dose and maintenance rate suggested by the supplier.
  • the loading dose calculation flow chart is provided in FIG. 2F where the calculation based on the maximum label dose is shown as program step 260 .
  • the anesthetic delivery system (ADS) will automatically deliver it, prior to starting the maintenance rate (MR).
  • the loading dose can be administered in a rapid induction model or a controlled induction model (see program determination 262 ).
  • the ADS can deliver the LD at the maximum pump rate.
  • 999 ml/hr will be used as the maximum pump rate.
  • the 166.67 is the conversion based on 60 min/hr, and 1,000 ⁇ g/mg, and 10 mg/ml (propofol concentration).
  • the ADS then delivers the loading dose for INTEGER(LD_Intervals) at a pump rate 999 ml/hr, and then delivers at IR_LD_remain for one interval. This is shown if FIG. 2B in program steps 226 and 228 .
  • the ADS starts delivery of the MR (actually at a pump rate of MR_ml/hr).
  • the ADS can deliver the LD over a specified period of time, with a decreasing ramp that culminates at the maintenance rate.
  • 3 minutes 180 seconds
  • the area of the rectangle (dashed line in FIG. 3 ) defined by the Controlled Induction period (180 seconds) and the Temp_rate equals the LD.
  • the objective is to calculate a ramp, such that the area under the ramp is equal to the area of the rectangle defined by the Temp_rate. This is accomplished with basic geometry. First, since the ramp terminates into the Maintenance Rate (dotted line at 75 ⁇ g/kg/min in FIG. 3 ) at the end of the Controlled Induction period, the area under the Maintenance Rate can be ignored for the following analysis—so the focus can be on the areas above the MR.
  • the DC ramp is actually a series of decreasing steps (each step defined by the sampling interval, which is 1.5 seconds in this illustration).
  • the area under this “staircase” must equal the area under the ramp, in order for the LD to be correct.
  • the same geometrical principal applied above applies here as well, and is illustrated in FIG. 4 . If the height of each step is equal to the average height of the ramp over the step interval the areas will be the same.
  • Start_IR MR+2*Delta ⁇ (Slope/2)/40 where 40 is the number of samples taken over a minute (1.5 second intervals)—converting the slope from “per minute” to “per interval.”
  • DC could simply deliver the Temp_Rate over the entire time period, then switch to the Maintenance Rate.
  • FIG. 2B of the flow chart the system gives the clinician the option in program step 220 of selecting between the rapid induction mode 222 or the controlled induction mode 224 .
  • the method described above basically portrays how anesthesiologists, who are trained in pharmacokinetic principals, sedate a patient.
  • the DC is advantageous because it automatically correlates the loading dose with the maintenance rate (or vice versa) so that only one variable is needed to compute the other. For example, whereas in the prior art, the physician needed a value for both the loading dose and the maintenance rate in order to rapidly initiate and maintain sedation, a ADS using the DC is able to calculate the appropriate loading dose based on a given maintenance rate. Thus, by entering the desired maintenance rate for the patient, DC automatically calculates the loading dose needed to rapidly bring the patient's level of sedation to the selected maintenance rate. The loading dose is administered followed by the constant infusion at the specified maintenance rate.
  • the DC can also calculate a maintenance rate based on a given loading dose value.
  • MR 75* LD /(0.5* W ) B. Adjusting Level of Sedation
  • DC also allows for rapid adjustment to a new level of sedation when the clinician programs a new maintenance rate.
  • an anesthesiologist intra-procedurally decides to change the patient's level of sedation, he will typically adjust only the infusion rate, and not deliver another loading dose. This results in a slower adjustment from the present level of sedation to the new level of sedation.
  • DC can calculate an incremental loading dose for each change in maintenance rate. This results in a significantly quicker adjustment because delivering an additional bolus rapidly brings the patient to the new level of sedation.
  • a correlation is established between loading dose and maintenance rate. Based upon this correlation, by tracking the accumulated loading dose, the ADS can quickly define a bolus or incremental loading dose that will rapidly produce a level of sedation that is consistent with the new maintenance rate.
  • the clinician programs changes in the level of sedation he or she desires by inputting a new maintenance rate that the clinician associates with the desired level of sedation.
  • DC will calculate the loading dose required for the new maintenance rate based on the equation above and then subtract the total loading doses previously given (cumulative loading dose—LD_cum) as shown in FIG. 2F step 262 to compute the incremental loading dose value to be administered to the patient.
  • Incremental LD 0.5* W *( MR _new/75) ⁇ LD _cum
  • the ADS will deliver this “incremental” loading dose to rapidly bring the patient from the present level of sedation to the new level, and then maintain this new level of sedation at the new maintenance rate.
  • the loading dose needed to rapidly increase the patient from the present level of sedation to the new level of sedation is calculated by calculating an initiation loading dose for the new maintenance rate and then subtracting the cumulative loading dose already delivered to the patient as shown in FIG. 2F , step 262 .
  • FIG. 2E illustrates the calculation of the cumulative loading dose. In the illustration the cumulative loading dose is adjusted to add the amount of loading dose added during a sample interval. Calculation of the cumulative loading dose when the addition of the incremental loading dose is made by the rapid induction method is shown at program step 252 in FIG. 2E . Alternatively, this addition can occur using the controlled induction as shown in program step 250 in FIG. 2E . When the loading dose is negative, the cumulative loading dose is reduced as shown at 254 .
  • LD was 0.33 mg/kg.
  • an incremental loading dose of 0.17 should be given to increase the patient from the present level of sedation to the new level of sedation.
  • the new LD cum would then be 0.50 mg/kg which would be used to calculate a new incremental loading dose if another new maintenance rate is desired.
  • the “administration” of the incremental loading dose during a procedure when a physician decides to increase the maintenance rate differs from when a physician decides to decrease the present maintenance rate as further described below.
  • the physician may determine that the patient is under-sedated and increase the maintenance rate. In order to rapidly bring the patient's level of sedation to the new level of sedation, an incremental loading dose will be delivered to the patient.
  • the ADS will deliver the LD as quickly as possible, setting the pump rate to a maximum rate (e.g., 999 ml/hr) until the LD is delivered.
  • a maximum rate e.g., 999 ml/hr
  • DC must deliver the LD on top of an existing MR and the existing infusion rate must be accounted for in the calculation of the LD time.
  • MR_new the new maintenance rate
  • LD_intervals is not an integer
  • the ADS will deliver the loading dose at a pump rate of 999 ml/hr for INTEGER(LD_intervals) and then at an infusion rate of IR_LD_remain for one sample. After delivering the LD the ADS will set MR to MR_new, and begin delivery of the new maintenance rate.
  • the ADS will deliver the LD over the specified time period (3 minutes for illustration) on top of the existing MR. See step 269 in FIG. 2F .
  • the maintenance rate value is not the new maintenance rate (MR_new), but the rate prior to changing the maintenance rate. In this way, the loading dose is being administered on top of the existing maintenance rate.
  • the incremental LD can delivered at a constant rate over the “controlled induction” period.
  • the cumulative loading dose is also decreased as shown in program step 254 in FIG. 2E .
  • the ADS will stop delivery of propofol for INT(Zero_intervals) and then begin infusing at an infusion rate of IR_zero_remain for one sample. After completing the LD, the ADS will set the maintenance rate to MR_new, and begin delivery of the new maintenance rate.
  • FIG. 2A shows in program step 210 the determination that the bolus (PRN) is an intra-procedure addition that does not affect the loading dose.
  • the ADS will deliver the Bolus at a pump rate of 999 ml/hr for INTEGER (Bolus_intervals), and then at an infusion rate of IR_B_remain for one sample. After delivering the Bolus, the DC will renew the delivery of the maintenance rate.
  • the bolus can be delivered over a fixed time interval, similar to a Controlled Induction delivery of a LD during a maintenance rate increase.
  • This calculation is used in program step 240 in FIG. 2D .
  • the cumulative loading dose here would be equivalent to the cumulative loading dose at the old maintenance rate plus the total amount of loading dose delivered during the Rapid Induction prior to when the physician changed the maintenance rate during the Rapid Induction as shown in FIG. 2E program step 252 .
  • DC next treats this change as a standard rate change (either increase or decrease) from the apparent maintenance rate to the new maintenance rate.
  • standard rate change either increase or decrease
  • the loading dose will still be delivered in the original 3 minute period.
  • a new constant infusion rate is calculated, that will deliver the new incremental LD over the remaining time.
  • the Dosage Controller must recalculate a slope and initial infusion rate.
  • the DC can be configured to require any change during a Controlled Induction to start a new 3 minute clock. In this case the original 3 Minute Induction equations would be used.
  • the loading dose can be interrupted as the ADS delivers the bolus. Immediately after delivering the bolus the loading dose is resumed where it left off.
  • the DC notes the maintenance rate change request, but continues with the delivery of the bolus. Immediately after the bolus has been delivered, the DC switches into a new maintenance rate mode.
  • a Supervisory Shell is a function embedded in automated drug delivery systems that is designed to monitor drug delivery based upon control parameters in addition to the maintenance rate and loading dose correlation discussed above.
  • Elements of a Supervisory Shell can include (but are not limited to):
  • the DC can treat this as a normal decrease in maintenance rate (stopping infusion is considered as a “decrease to zero”).
  • a Zero_time will be calculated, and the cumulative loading dose will be integrated down every interval. At the end of the Zero_time the cumulative LD will equal zero.
  • the DC may treat it as a change in MR from the apparent MR (at the time the clinician decided to re-start infusion) to the new MR. If the new MR is greater than the apparent MR it will be treated as a MR increase. If the new MR is less than the apparent MR it will be treated as a decrease (negative LD).
  • the clinician can choose either a Rapid or a Controlled Induction, however, if the LD is negative DC defaults to the Time_zero format. In addition, the clinician does not necessarily have to wait until the adverse physiology clears before re-starting drug delivery.
  • a Supervisory Shell may be designed to reduce drug delivery in response to certain conditions—such as adverse trends. If the Supervisory Shell simply requests a fixed reduction (say 20% for example) in the maintenance rate DC will handle this as a standard MR decrease.
  • An alternative way to integrate DC within a Supervisory Shell to reduce infusion rate in response to an adverse trend is to take advantage of the apparent maintenance rate concept and tune the size of the infusion rate reduction to the severity of the patient's condition, as indicated by the trend. Specifically, upon detecting worsening physiology the Supervisory Shell can instruct DC to set the MR to zero. This will cause DC to calculate a Time_zero and begin integrating down the cumulative LD.
  • the Supervisory Shell can inform DC to re-establish drug delivery at the apparent MR (which exists at the time the physiology returns to normal). In this manner, the longer the patient's physiology is trending poorly, the larger the reduction in the infusion rate.
  • a Supervisory Shell may also be designed to temporarily stop drug delivery if it detects a correctable problem within the ADS. These problems could include (but not limited to) a dislodged pulse oximeter probe, a disconnected ECG lead, air-in-line detected in the infusion line, or IV bag/vial empty. If the Supervisory Shell stops delivery of drug in response to such a problem, DC first saves the present maintenance rate then performs a decrease in maintenance rate, with the new MR being zero. When the clinician corrects the problem, DC calculates the apparent maintenance rate based on the cumulative loading dose at the time the problem is corrected. Then DC performs an increase in maintenance rate (in the Rapid Induction mode preferably) from the apparent maintenance rate to the saved maintenance rate.
  • IV drugs are typically titrated to clinical effect—the clinician must tune the infusion rate to achieve the target effect on each individual patient. Further, as the patient's needs change during the course of a medical procedure, the clinician will have to titrate the drug to maintain a desired target effect.
  • physiologic parameters such as blood pressure
  • the “loop” cannot be closed—this includes sedation/anesthesia.
  • the ADS may include a means of assessing a patient's level of sedation—the Automated Responsiveness Monitor (ARM).
  • ARM Automated Responsiveness Monitor
  • the DC will enable the clinician to more easily titrate the delivery of propofol to each individual patient.
  • One method of using ARM comprises applying a vibration stimuli or request for a predetermined response to the patient; instructing the patient to respond to the vibration stimuli; and monitoring the patient's response to the vibration stimuli. This action is repeated at a predetermined interval throughout the medical procedure
  • FIG. 2 illustrates a conscious sedation system 100 including a controller 102 and a response testing apparatus 104 .
  • the controller 102 generates a request for a predetermined response from a patient 106 and analyses at least a response generated by the patient 106 to the request to determine a level of sedation of the patient 106 .
  • the response testing apparatus 104 includes a request assembly 108 and a response assembly 110 .
  • the request assembly 108 communicates to the patient 106 the request generated by the controller 102 .
  • the response assembly 110 is used by the patient 106 to generate the response and communicates the response to the controller 102 .
  • Example of response assemblies particularly useful herein are hand grip assemblies as described in detail in commonly assigned patent application Ser. No. 10/674,160 entitled Response Testing for Conscious Sedation Involving Hand Grip Dynamics filed on Sep. 29, 2003 (atty docket 451231-017).
  • the response assembly includes a handpiece which senses a dynamic variable of a hand grip response made by the patient to the request and communicates the dynamic variable to the controller which analyzes at least the dynamic variable to determine a level of sedation of the patient.
  • One method of integrating DC with the ARM and a Supervisory Shell is to limit maintenance rate increases based on the patient's responsiveness. For example, if the patient is unresponsive to ARM, the system will not allow the user to increase the MR, but if the patient is responsive there would be no ARM linked limits on increasing the MR. Alternatively, maintenance rate increase limits can be based on the patient's level of responsiveness.
  • the MR might be increased by 30 ⁇ g/kg/min in the case of propofol, if the response occurs between 5 and 10 seconds the MR can be increased by 20 ⁇ g/kg/min, and if the response occurs in greater than 10 seconds the MR can only be increased by a limited amount such as 10 ⁇ g/kg/min.
  • This control function is illustrated in the flow chart provided as FIG. 2I where control steps 290 , 292 and 294 correspond respectively to MR increases triggered by ARM response times of less than 5, 5 to 10 and 10 or more seconds.
  • the patient's response to ARM may be used as a Supervisory Shell feature in monitoring and adjusting the maintenance rate especially for long procedures.
  • concentration of a drug in the body will gradually increase. This can lead to unexpected over-dosage, and accompanying adverse events.
  • Propofol labeling calls for a reduction in infusion rate 15-20 minutes after initiating a Maintenance Rate infusion.
  • a Supervisory Shell, integrated into the DC can automatically perform this suggested reduction effectively maintaining a safe level of sedation.
  • the integrated system will not perform an automatic reduction.
  • the system can reduce the maintenance bate by a fixed amount (5% for example). This is repeated every 15 minutes, as long as the patient remains non-responsive to ARM. As soon as the patient regains responsiveness the reductions are stopped. Should the patient lose responsiveness again, for 15 continuous minutes the reductions will start again.
  • DC of this invention these MR reductions will rapidly and effectively reduce the patient's level of sedation.
  • a further embodiment incorporates a patient-tuned sedation feature with DC. Since differences in effective analgesia or anesthesia dosages can be dramatic even among physically similar patients who are subjected to very similar pain-producing circumstances, it could be desirable to develop a system that incorporates patient input in the delivery of the drugs. The concept is to include the benefits of patient controlled sedation with the benefits of DC.
  • analgesia or anesthesia that is needed by a particular patient at a particular time
  • the “best” pain expert for a particular patient is the patient himself or herself—as opposed to the patient's physician.
  • physicians may have the knowledge and experience that is needed to determine a suitable dosage range to meet the needs of a particular patient, it tends to be the patient, not the physician, who is the best judge of the dosage within the physician-set range that best serves the needs of the patient at a particular time and under the circumstances of the moment.
  • the effectiveness of the administration of analgesia or anesthesia often can be enhanced when the dosing of the drug is being controlled by the patient—with safety considerations being kept in mind to prevent overdose. Accordingly, it is desired to provide a system which combines the benefits of DC with the benefits of patient controlled sedation.
  • the system in this embodiment may also incorporate the advantages of DC and ARM with advantages of patient controlled sedation to form another embodiment of the present invention—Patient Tuned System (PTS).
  • PTS Patient Tuned System
  • the patient In patient tuned sedation, the patient, with an ARM-like device, is acting as the depth of sedation sensor, essentially, closing the loop on sedation.
  • the system would include all of the patient monitors currently in the sedation delivery system such as ECG, capnometry, pulse oximetry, and NIBP.
  • the level of sedation that is desired for the Anesthetic Delivery System is the transition between moderate and deep sedation.
  • This transition point is well defined by the patient's loss of responsiveness to ARM.
  • the patient's loss of responsiveness to ARM corresponds with the point where a patient can no longer dose himself with a patient tuned sedation system.
  • the patient's responsiveness to ARM acts as a dose limiter so that when the patient loses responsiveness, the patient can't send any response to deliver more drug.
  • there is a lock-out period that follows a patient's response, such as pressing a button to deliver additional drugs, to prevent the patient from overdosing himself.
  • the Patient Tuned Sedation starts by having the clinician enter a “ballpark” maintenance rate along with the patient's weight.
  • the system would begin by delivering an initiation loading dose calculated from DC in accordance with the invention.
  • the ARM-like device After a specified time period, typically 90 seconds, the ARM-like device sends a request for a patient's response.
  • the request may be, for example, an audible signal such as “Squeeze your hand if you are feeling discomfort.”
  • the message may be repeated every 60 seconds.
  • the PTS will increase the maintenance rate by 10 ⁇ g/kg/min, utilizing DC to rapidly achieve the new sedation level. At this point, the PTS will be locked out from increasing the maintenance rate for 60 seconds regardless of how many times the patient squeezes his hand. This acts as a safety precaution to prevent the patient from over-sedation. If the patient responds, less quickly, for example, between 3 and 10 seconds, the PTS would increase the maintenance rate by 5 ⁇ g/kg/min. If it took the patient a greater time to respond, for example more than 10 seconds, the PTS would not increase the maintenance rate, but would rather deliver a small bolus ( ⁇ 0.025 mg/kg).
  • the maintenance rate increase could be larger, say 25 ⁇ g/kg/min for a response within 3 seconds, 12 ⁇ g/kg/min for responses between 3 and 10 seconds and a 0.1 mg/kg bolus for longer responses, but the lock-out period would be longer, on the order of 3 to 5 minutes.
  • the PTS would not deliver any additional drug. Further, if the patient does not respond during 3 consecutive queries, the PTS would begin a slow decrease in the maintenance rate, for example, 5% every 15 minutes. This is intended to keep the non-responsive or deeply sedated patient from entering a state of general anesthesia.
  • the patient acts as the depth of sedation monitor, essentially closing the loop on sedation.

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US10/886,255 2004-07-07 2004-07-07 Dosage control for drug delivery system Abandoned US20060009734A1 (en)

Priority Applications (15)

Application Number Priority Date Filing Date Title
US10/886,255 US20060009734A1 (en) 2004-07-07 2004-07-07 Dosage control for drug delivery system
EP05757429A EP1781367A4 (fr) 2004-07-07 2005-06-09 Regulation de dosage pour systeme de distribution de medicament
CN200580027258XA CN101001662B (zh) 2004-07-07 2005-06-09 用于药物输送系统的剂量控制
AU2005272122A AU2005272122B2 (en) 2004-07-07 2005-06-09 Dosage control for drug delivery system
CA2572994A CA2572994C (fr) 2004-07-07 2005-06-09 Regulation de dosage pour systeme de distribution de medicament
MX2007000351A MX2007000351A (es) 2004-07-07 2005-06-09 Control de dosificacion para sistema de administracion de farmacos.
KR1020077003001A KR101298508B1 (ko) 2004-07-07 2005-06-09 약물 전달 시스템을 위한 투여량 제어
PCT/US2005/020149 WO2006016952A2 (fr) 2004-07-07 2005-06-09 Regulation de dosage pour systeme de distribution de medicament
BRPI0511447-0A BRPI0511447A (pt) 2004-07-07 2005-06-09 controle de dosagem para sistema de distribuição de drogas
NZ601704A NZ601704A (en) 2004-07-07 2005-06-09 Drug delivery system for dosage control having a pump and a controller
JP2007520311A JP4980214B2 (ja) 2004-07-07 2005-06-09 薬剤送達システムの投与量制御
TW094122771A TWI445560B (zh) 2004-07-07 2005-07-06 藥物遞送系統之劑量控制
CR8910A CR8910A (es) 2004-07-07 2007-02-07 Control de dosificacion para sistemas de administracion de farmacos
US11/695,775 US20070191817A1 (en) 2004-07-07 2007-04-03 Dosage control for drug delivery system
US13/038,841 US8622989B2 (en) 2004-07-07 2011-03-02 Dosage control for drug delivery system

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US11/695,775 Abandoned US20070191817A1 (en) 2004-07-07 2007-04-03 Dosage control for drug delivery system
US13/038,841 Expired - Lifetime US8622989B2 (en) 2004-07-07 2011-03-02 Dosage control for drug delivery system

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EP (1) EP1781367A4 (fr)
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KR (1) KR101298508B1 (fr)
CN (1) CN101001662B (fr)
AU (1) AU2005272122B2 (fr)
BR (1) BRPI0511447A (fr)
CA (1) CA2572994C (fr)
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NZ (1) NZ601704A (fr)
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CN101001662A (zh) 2007-07-18
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US8622989B2 (en) 2014-01-07
AU2005272122B2 (en) 2011-09-29
EP1781367A2 (fr) 2007-05-09
CN101001662B (zh) 2010-09-22
CR8910A (es) 2009-01-16
BRPI0511447A (pt) 2007-12-26
US20070191817A1 (en) 2007-08-16
KR101298508B1 (ko) 2013-08-22
WO2006016952A2 (fr) 2006-02-16
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AU2005272122A1 (en) 2006-02-16
US20110152828A1 (en) 2011-06-23

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