Method and sedation delivery system including a pump assembly and a co-formulation of first and second drugs

• US 9,480,789 B2
• Filed: 06/01/2009
• Issued: 11/01/2016
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Martin, James F., Bruggeman, Paul
• Primary Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/475,697
• Publication Number:
  US 20100300438A1
• Time in Patent Office: 2,710 Days
• Field of Search: 128/203.14, 514/649, 514/329, 235/462.01
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A drug delivery system includes drug containers, a pump assembly, a sensor, and a controller. The drug containers each contain a different predetermined drug co-formulation of predetermined first and second drugs, wherein the first drug has a sedative effect. The sensor is adapted to sense a variable associated with the drug containers and output a different drug co-formulation identification signal associated with each of the drug containers based on the sensed variable. The controller is programmed to identify the drug co-formulation for the drug container operatively connected to the pump assembly from the associated identification signal and to control the pump assembly to deliver the drug co-formulation of the one drug container to the patient during a medical procedure according to a corresponding drug delivery algorithm which is different for each of the drug containers. A method is also disclosed which uses the drug delivery system.

Claims

1. A drug delivery system comprising:

a) a plurality of drug containers each container of the plurality of containers containing a different predetermined drug co-formulation of a predetermined first drug and a predetermined second drug, wherein the first drug has a sedative effect;

b) a pump assembly, wherein each of the plurality of drug containers is operatively connectable to the pump assembly, and wherein the pump assembly is adapted to deliver the drug co-formulation contained in an operatively-connected one of the plurality of drug containers to a patient during a medical procedure;

c) a sensor adapted to sense a variable associated with each of the plurality of drug containers and output a different drug co-formulation identification signal associated with each of the plurality of drug containers based on the sensed variable; and

d) a controller operatively connected to the sensor and to the pump assembly, wherein the controller is programmed to identify the drug co-formulation for the operatively-connected one of the plurality of drug containers from the associated identification signal and to control the pump assembly to deliver the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure according to a corresponding drug delivery algorithm which is different for each of the drug containers.

2. The drug delivery system of claim 1, wherein the second drug has an analgesic effect.

3. The drug delivery system of claim 2, wherein the first drug substantially lacks having an analgesic effect, and wherein the second drug substantially lacks having a sedative effect.

4. The drug delivery system of claim 1, wherein the different predetermined drug co-formulations include at least first, second, third, and fourth drug co-formulations.

5. The drug delivery system of claim 1, wherein the first drug co-formulation includes 100 percent of a predetermined first amount of the first drug and includes 0 percent of a predetermined second amount of the second drug, wherein the second drug co-formulation includes from 60 to 90 percent of the first amount of the first drug and includes from 10 percent to 40 percent of the second amount of the second drug, and wherein the third drug co-formulation includes from 10 percent to 40 percent of the first amount of the first drug and includes from 60 percent to 90 percent of the second amount of the second drug.

6. The drug delivery system of claim 1, wherein the first drug is propofol and the second drug is ketamine.

7. The drug delivery system of claim 1, wherein the first drug is propofol and the second drug is remifentanil.

8. The drug delivery system of claim 1, wherein the plurality of drug containers each have substantially a same shape and a different size, wherein the variable is the different size, and wherein the sensor senses the size.

9. The drug delivery system of claim 1, also including a different bar code associated with each of the plurality of drug containers, wherein the variable is the different bar code, and wherein the sensor is adapted to automatically sense the bar code associated with the operatively-connected one of the plurality of drug containers.

10. The drug delivery system of claim 1, also including a different bar code associated with each of the plurality of drug containers, wherein the variable is the different bar code, and wherein the different bar code associated with each of the plurality of drug containers is placed on the associated drug container.

11. The drug delivery system of claim 1, also including a different bar code associated with each of the plurality of drug containers, wherein the variable is the different bar code, and wherein the different bar code associated with each of the plurality of drug containers is placed on at least one of an associated drug-container package and an associated drug-delivery cassette.

12. The drug delivery system of claim 1, wherein the controller is programmed to receive a plurality of physiological parameters of the patient during the medical procedure, and wherein the controller is programmed to have the corresponding drug delivery algorithm adjust a flow rate of the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure as a function of at least the received physiological parameters.

13. The drug delivery system of claim 12, wherein the controller is programmed to generate at least one alarm signal based at least on the received physiological parameters.

14. The drug delivery system of claim 12, wherein the controller is adapted to receive a user input and to modify the adjusted flow rate of the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure based on the received user input.

17. A method for delivering drugs to patients during medical procedures using the drug delivery system of claim 1 wherein the plurality of drug containers includes at least four drug containers, wherein the at-least-four drug containers includes first and second drug containers, and wherein the method comprises:

a) choosing the first drug container based on a first medical procedure and an assessment of a patient associated with the first medical procedure;

b) having the sensor sense the variable associated with the first drug container and output the identification signal associated with the first drug container;

c) having the controller automatically determine a first drug delivery algorithm based on the identification signal associated with the first drug container;

d) having the controller control the pump assembly to deliver the drug co-formulation of the first drug container to the patient associated with the first medical procedure based at least on the first drug delivery algorithm;

e) choosing the second drug container based on a second medical procedure and an assessment of a patient associated with the second medical procedure, wherein at least one of the second medical procedure and the patient associated with the second medical procedure is different from the corresponding one of the first medical procedure and the patient associated with the first medical procedure;

f) having the sensor sense the variable associated with the second drug container and output the identification signal associated with the second drug container;

g) having the controller automatically determine a second drug delivery algorithm based on the identification signal associated with the second drug container, wherein the second drug delivery algorithm is different from the first drug delivery algorithm; and

h) having the controller control the pump assembly to deliver the drug co-formulation of the second drug container to the patient associated with the second medical procedure based at least on the second drug delivery algorithm.

18. The method of claim 17, wherein the second drug has an analgesic effect.

19. The method of claim 18, wherein the first drug is propofol and the second drug is ketamine.

20. The method of claim 18, wherein the first drug is propofol and the second drug is remifentanil.

15. A drug delivery system comprising:

a) a plurality of drug containers each container of the plurality of containers containing a different predetermined drug co-formulation of a predetermined first drug and a predetermined second drug, wherein the first drug has a sedative effect, wherein the second drug has an analgesic effect, and wherein the different predetermined drug co-formulations include at least four different drug co-formulations;

b) a pump assembly, wherein each container of the plurality of drug containers is operatively connectable to the pump assembly, wherein one container of the plurality of drug containers is operatively connected to the pump assembly, and wherein the pump assembly is adapted to deliver the drug co-formulation contained in the operatively-connected one of the plurality of drug containers to a patient during a medical procedure;

c) a sensor adapted to sense a variable associated with each container of the plurality of drug containers and output a different drug co-formulation identification signal associated with each container of the plurality of drug containers based on the sensed variable; and

d) a controller operatively connected to the sensor and to the pump assembly, wherein the controller is programmed to identify the drug co-formulation for the operatively-connected one of the plurality of drug containers from the associated identification signal and to control the pump assembly to deliver the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure according to a corresponding drug delivery algorithm which is different for each of the plurality of drug containers.

16. The drug delivery system of claim 15, wherein the controller is programmed to receive a plurality of physiological parameters of the patient during the medical procedure, wherein the controller is programmed to have the corresponding drug delivery algorithm adjust a flow rate of the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure as a function of at least the received physiological parameters, and wherein the controller is adapted to receive a user input and to modify the adjusted flow rate of the drug co-formulation of the operatively-connected one of the plurality of drug containers to the patient during the medical procedure based on the received user input.