Method for intravenous drug infusion

• US 5,409,456 A
• Filed: 07/07/1994
• Issued: 04/25/1995
• Est. Priority Date: 09/11/1991
• Status: Expired due to Fees

• Current Assignee: University of Melbourne
• Original Assignee: University of Melbourne
• Inventors: Crankshaw, David P.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): WILKENS, FRANK
• Application Number:
  US08/204,346
• Time in Patent Office: 292 Days
• Field of Search: 604/49-53, 604/65-67, 604/154, 604/155, 128/DIG. 1, 128/DIG. 13
• US Class Current: 604/503
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A method and system for the infusion of a drug into a patient involving: (i) calculating a multiplicity of infusion rate profiles for a selected drug by monitoring drug efflux from the body of a group of patients for a corresponding multiplicity of target concentrations of the selected drug; (ii) determining the body size of the patient, such as their Lean Body Mass; (iii) selecting a target concentration of the drug to, in turn, cause selection from the multiplicity of infusion rate profiles of an infusion rate profile substantially corresponding to the infusion rate profile for the selected target concentration; (iv) scaling the selected infusion rate profile by the determined body size or Lean Body Mass of the patient; and (v) administering the drug to the patient in accordance with the scaled profile by means of an infusion device which is controlled to deliver said drug at said scaled infusion rate profile. By using the aforesaid method and system, drugs which are non-linear in their effect on a patient are able to be delivered to the patient in a much more accurate manner thereby avoiding overdosing or underdosing of the drug and the undesirable consequences thereof.

Claims

1. A method of infusion of an anaesthetic agent into a patient comprising the steps of:

(i) calculating a multiplicity of infusion rate profiles for a selected agent by monitoring drug efflux from the body of a group of patients for a corresponding multiplicity of target concentrations of the selected agent, said multiplicity of infusion rate profiles including at least a set of profiles which cause the induction of light, average and deep anaesthesia in the patient;

(ii) determining the body size of the patient, such as their Lean Body Mass;

(iii) selecting a target concentration of the agent to in turn cause selection from the multiplicity of infusion rate profiles an infusion rate profile substantially corresponding to the infusion rate profile for the selected target concentration;

(iv) scaling the selected infusion rate profile by the determined body size or Lean Body Mass of the patient; and

(v) administering the agent to the patient in accordance with the scaled profile by means of an infusion device which is controlled to deliver said agent at said scaled infusion rate profile.

2. The method of claim 1, wherein each said profile is determined by:

(a) infusing an agent at arbitrary but known rates into a group of patients for each of whom the Lean Body Mass has been determined;

(b) determining the plasma arterial concentration of the agent in each patient at a number of specific time intervals throughout each infusion period;

(c) for each patient, estimating the rates of loss of agent from the circulation at a number of specific time instants by dividing the known infusion rates per Lean Body Mass of these instants by the plasma arterial concentrations of the agent at each of these instants;

(d) calculating the average of the estimated rates of loss of agent from the circulation per Lean Body Mass unit at each specific time interval for the group of patients;

(e) interpolating the successive average points between the specific time intervals to produce an infusion profile;

(f) infusing said agent in accordance with said infusion profile determined from said interpolations into a group of patients for each of whom the Lean Body Mass has been determined, said infusion rate being scaled according to said Lean Body mass of each patient; and

(g) repeating steps (b) to (f) until a desired steady plasma arterial content of the drug is substantially maintained throughout the infusion period.

3. The method of claim 1, wherein said profiles are stored in a data storage and processing device which controls said infusion device at a rate which is subjected to said scaling.

4. The method of claim 2, wherein said profiles are stored in a data storage and processing device which controls said infusion device at a rate which is subjected to said scaling.

5. The method of claim 3, further comprising the step of storage in the storage device of a further multiplicity of similarly determined infusion rate profiles where an anaesthetic agent such as nitrous oxide has been used in addition to the selected anaesthetic agent to induce the desired level of anaesthesia, and selecting one of the profiles where said another agent such as nitrous oxide is used to achieve anaesthesia in the patient.

6. The method of claim 4, further comprising the step of storage in the storage device of a further multiplicity of similarly determined infusion rate profiles where an anaesthetic agent such as nitrous oxide has been used in addition to the selected anaesthetic agent to induce the desired level of anaesthesia, and selecting one of the profiles where said another agent such as nitrous oxide is used to achieve anaesthesia in the patient.

7. The method of claim 1 further comprising, in the case where the stored infusion rate profiles do not correspond to the selected target concentration, the step of calculating the infusion rate by interpolation at each time interval between the rate profile values for target concentrations on either side of the selected target concentration.

8. An infusion system for regulating the delivery of an anaesthetic agent to a patient, including control means for controlling the operation of an infusion pump, said control means including pre-programmed means for varying the infusion rate with respect to elapsed time, said pre-programmed means being programmed with a multiplicity of infusion rate profiles which have been determined by a drug efflux method, and which correspond to a multiplicity of target concentrations of the agent, said multiplicity of infusion rate profiles including at least a set of profiles which cause the induction of light, average and deep anaesthesia in the patient, scaling means for setting the body size or Lean Body Mass of the patient, means for selecting a target concentration to cause selection of the corresponding infusion rate profile so that the pre-programmed means varies the infusion rate in accordance with the corresponding drug infusion rate profile, said scaling means causing modification of the selected pre-programmed infusion rate profile by a fixed proportion over each time period of operation of said infusion pump.

9. The system of claim 8, in which said pre-programmed means is further programmed with a multiplicity of infusion rate profiles which have been determined by a drug efflux method in which a group of patients are administered more than one anaesthetic agent, such as nitrous oxide, to induce the desired level of anaesthesia, and means for selecting one of said profiles where the additional anaesthetic agent such as nitrous oxide is used to achieve anaesthesia in the patient.