Method and device for administering medication and/or placebo

• US 6,973,374 B2
• Filed: 12/19/2001
• Issued: 12/06/2005
• Est. Priority Date: 12/19/2000
• Status: Expired due to Fees

• Current Assignee: University of Rochester
• Original Assignee: University of Rochester
• Inventors: Ader, Robert
• Primary Examiner(s): Gandhi, Jayprakash N.
• Application Number:
  US10/450,879
• Publication Number:
  US 20040153214A1
• Time in Patent Office: 1,448 Days
• Field of Search: 700/281, 700/282, 604/90.01, 604/131, 604/186, 604/207, 604/246, 604/500
• US Class Current: 700/282
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A control device and a drug delivery system containing such a control device are disclosed for delivery to a patient of a drug or a placebo (or ineffective dose of the drug) according to a partial reinforcement schedule, whereby the placebo (or ineffective dose of the drug) is delivered in whole or in part during one or more delivery events. Methods of modulating the drug/placebo delivery to a patient are also provided, whereby the delivery event is initiated either according to a patient-initiated signaling event (i.e., a self-medication mode) or an automated signaling event (i.e., automated mode).

Claims

1. A control device for a drug delivery system equipped to deliver at least two fluids, an effective dose of a drug in fluid form and either a placebo or an ineffective dose of the drug in fluid form, the control device comprising:

a processor that is controlled in accordance with a set of program instructions that determine a partial reinforcement schedule for drug administration;

a memory, coupled to the processor, said memory storing the set of program instructions and a set of parameters for the partial reinforcement schedule; and

a user interface, coupled to the processor, said user interface enabling a user to input at least some of the set of parameters used by the partial reinforcement schedule;

wherein the processor, in executing the set of program instructions, delivers the effective dose of the drug, the placebo or ineffective dose of the drug, or both, to a patient according to the partial reinforcement schedule.

2. The control device according to claim 1 further comprising:

a display, coupled to the processor, on which are displayed the set of parameters or status of the partial reinforcement schedule.

3. The control device according to claim 1 wherein the processor is controlled by the set of program instructions and the set of parameters to administer the effective dose of the drug, the placebo or ineffective dose of the drug, or both, whereby each delivery event is randomly selected according to a probability determined by the set of parameters.

4. The control device according to claim 3 further comprising:

a random events generator, coupled to the processor, said random events generator signaling to the processor whether the effective dose of the drug, the placebo or ineffective dose of the drug, or both, are to be delivered to the patient on a particular delivery event.

5. The control device according to claim 1 further comprising:

a switch, coupled to the processor, enabling the user to select between a manual mode and an automated mode for controlling the timing of processor execution of the set of program instructions.

6. The control device according to claim 5 further comprising:

a wired or wireless remote device, coupled to the processor, for signaling to processor when to execute the set of program instructions.

7. A drug delivery system comprising:

a housing;

a first receptacle in said housing which is adapted to receive a first container comprising an effective dose of a drug in fluid form;

a second receptacle in said housing which is adapted to receive a second container comprising a placebo or an ineffective dose of the drug in fluid form;

an outlet which, upon introduction of the first and second containers into the first and second receptacles, respectively, is in communication therewith;

one or more pumps which act upon the first and second containers; and

a control device which controls operation of the one or more pumps to deliver the effective dose of the drug or the placebo or ineffective dose of the drug from the outlet according to a partial reinforcement schedule, whereby the placebo or ineffective dose of the drug is delivered in whole or in part during one or more delivery events.

8. The drug delivery system according to claim 7, wherein the control device comprises:

a processor that is controlled in accordance with a set of program instructions that determine the partial reinforcement schedule for drug administration; and

a memory, coupled to the processor, said memory storing the set of program instructions and a set of parameters for the partial reinforcement schedule.

9. The drug delivery system according to claim 8, wherein the control device further comprises:

a user interface, coupled to the processor, said user interface enabling a user to input at least some of the set of parameters used by the partial reinforcement schedule.

10. The drug delivery system according to claim 8 wherein the control device further comprises:

a display, coupled to the processor, on which are displayed the set of parameters or status of the partial reinforcement schedule.

11. The drug delivery system according to claim 8 wherein the control device further comprises:

a random events generator, coupled to the processor, said random events generator signaling to the processor whether the effective dose of the drug, the placebo or ineffective dose of the drug, or both, are to be delivered to the patient on a particular delivery event.

12. The drug delivery system according to claim 8 further comprising:

a switch, coupled to the processor, enabling the user to select between a manual mode and an automated mode for controlling the timing of processor execution of the set of program instructions.

13. The drug delivery system according to claim 7 wherein the one or more pumps comprise a first pump which acts upon the first container and a second pump which acts upon the second container.

14. The drug delivery system according to claim 7 further comprising:

a wired or wireless remote device, coupled to the processor, for signaling to processor when to execute the set of program instructions.

15. A method of automatically modulating drug/placebo delivery to a patient comprising:

connecting a fluid supply line of a patient to an outlet of a drug delivery system according to claim 7, with the drug delivery system provided with a first container comprising an effective dose of a drug in fluid form and a second container comprising either a placebo or an ineffective dose of the drug in fluid form;

programming the control device with a drug dosage rate for a predetermined period of time; and

operating the drug delivery system for the predetermined period of time, whereby drug delivery during the predetermined period of time is modulated by delivery of the placebo or the ineffective dose of the drug, either in whole or in part, during one or more delivery events occurring during the predetermined period of time.

16. The method according to claim 15 wherein said programming further comprises programming the control device with a partial reinforcement schedule for delivery of the placebo or the ineffective dose of the drug, either in whole or in part, during the one or more delivery events.

17. The method according to claim 15 wherein the second container comprises a placebo.

18. A method of modulating patient self-delivery of a drug comprising:

connecting a fluid supply line of a patient to an outlet of a drug delivery system according to claim 7, with the drug delivery system provided with a first container comprising an effective dose of a drug in fluid form and a second container comprising a placebo or an ineffective dose of the drug in fluid form;

programming the control device with a drug dosage rate; and

operating the drug delivery system, whereby drug delivery is modulated by delivery of the placebo or the ineffective dose of the drug, either in whole or in part, during one or more patient-regulated delivery events.

19. The method according to claim 18 wherein said programming further comprises programming the control device with a partial reinforcement schedule for delivery of the placebo or the ineffective dose of the drug, either in whole or in part, during the one or more patient-regulated delivery events.

20. The method according to claim 18 wherein the second container comprises a placebo.