Automated drug preparation apparatus including serial dilution functionality

• US 7,913,720 B2
• Filed: 10/31/2006
• Issued: 03/29/2011
• Est. Priority Date: 10/31/2006
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: FHT, Inc.
• Inventors: Deshpande, Vaibhav, Wallace, Morris W., Osborne, Joel A., Tribble, Dennis, Khan, Abdul Wahid
• Primary Examiner(s): Maust; Timothy L
• Assistant Examiner(s): ARNETT, NICOLAS ALLEN
• Application Number:
  US11/554,677
• Publication Number:
  US 20080169045A1
• Time in Patent Office: 1,610 Days
• Field of Search: 141 21- 23, 141/25, 141/27, 141/83, 141/100, 141/104, 141329-330, 604/407, 604/411, 604/416
• US Class Current: 141/27
• CPC Class Codes: B65B 2210/04 Customised on demand packaging by determining a specific characteristic, e.g. shape or height, of articles or material to be packaged and selecting, creating or adapting a packaging accordingly, e.g. making a carton starting from web material
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 57/00 Automatic control, checking, warning, or safety devices registering wrapping or container-forming material fed from rolls B65B41/18
• CPC Class Codes: B65B 59/00 Arrangements to enable machines to handle articles of different sizes, to produce packages of different sizes, to vary the contents of packages , to handle different types of packaging material, or to give access for cleaning or maintenance purposes
• CPC Class Codes: B65B 59/003 Arrangements to enable adjustments related to the packaging material

Abstract

An automated medication preparation system for preparing a prescribed dosage of medication in a drug delivery device includes a plurality of stations for receiving, handling and processing the drug delivery device so that the prescribed dosage of medication is delivered to the drug delivery device and a transporting device that receives and holds more than one drug delivery device and moves the drug delivery devices in a controlled manner from one station to another station. The system is configured so that two or more separate drug delivery devices can be acted upon at the same time.

Claims

1. An automated drug preparation system for preparing a prescribed dosage of medication in a syringe comprising:

a source of a first fluid that is for delivery to the syringe;

a source of a second fluid that is for delivery to the syringe, wherein one of the first and second fluid comprises a drug and the other of the first and second fluids comprises a diluent, the first and second fluids being different from one another;

an adjustable plunger extension mechanism that includes a movable component that intimately engages a plunger of the syringe so that a first movement of the movable component is translated into a first extension of the plunger a first defined distance which causes a first volume of the first fluid to be drawn into the syringe; and

a controller that includes stored medication orders including a final volume and concentration of the prescribed diluted dosage of medication, wherein and based on the stored medication orders, the controller calculates the first defined distance that the plunger is moved to draw the first volume of the first fluid and sends a signal to cause the plunger to extend the first defined distance, wherein when the first volume is less than the final volume, the controller calculates the difference between the final volume and the first volume and disengages the fluid communication between the source of the first fluid and the syringe and then calculates a second defined distance, the plunger is to be moved to permit reception of a second volume of the second fluid and sends a signal to cause the plunger to extend the second defined distance, wherein the sum of the first and second volumes is equal to the final volume.

2. The system of claim 1, wherein the prescribed dosage of medication is a diluted dosage of the second fluid and the first fluid is a diluent combined with the second fluid to produce the diluted dosage.

3. The system of claim 1, wherein the first fluid comprises a drug in liquid form and the second fluid comprises diluent that is combined with the first fluid to produce the diluted dosage.

4. The system of claim 1, wherein if the controller determines that the prescribed dosage of medication requires a volume of parent medication that is below a threshold volume, then dilution of the parent medication is required and the controller instructs the adjustable plunger extension mechanism to move moves the plunger to draw the first volume of the first fluid.

5. The system of claim 1, further including:

a first drug delivery station that includes a first automated drug delivery device that is in fluid communication with the source of first fluid and a second drug delivery station that includes a second automated drug delivery device that is different than the first automated drug delivery device and is in fluid communication with a source of the second fluid.

6. The system of claim 5, wherein the second fluid comprises medication that is reconstituted in a drug vial and then aspirated from the drug vial and injected into the syringe.

7. The system of claim 6, wherein the second automated drug delivery device is configured to perform the following operations:

(1) receiving diluent from a diluent supply in a prescribed amount to reconstitute the medication in the drug vial; and

(2) aspirating and later injecting the reconstituted medication from the drug vial into the syringe.

8. The system of claim 5, wherein the first automated drug delivery device draws the first fluid into the syringe without use of a pump and the second automated drug delivery device includes a pump that operates to inject the second fluid into the syringe.

9. An automated drug preparation system for preparing a prescribed dosage of medication in a syringe comprising:

a first drug delivery station that includes a first automated drug delivery device that is in fluid communication with a source of a first fluid that can be selectively delivered to the syringe;

an adjustable plunger extension mechanism that includes a movable component that intimately engages a plunger of the syringe so that a first movement of the movable component is translated into a first extension of the plunger a first defined distance;

a controller that includes stored medication orders including a final volume and concentration of the prescribed dosage of medication, wherein and based on the stored medication orders, the controller calculates the first defined distance that the plunger is moved to create a first volume for receiving the dosage of medication and causes the plunger to extend the first defined distance; and

a second drug delivery station that delivers medication into the syringe after the plunger has been extended, wherein the first and second drug delivery stations are different from one another in at least one aspect.

10. The system of claim 9, wherein the second drug delivery station operates in a first mode and delivers a prescribed amount of medication to the syringe and a second mode in which a prescribed amount of diluent is added to produce the dosage of medication.

11. The system of claim 9, wherein the first drug delivery station delivers a prescribed amount of first fluid which comprises diluent as a result of extension of the plunger, the volume of the diluent being less than the first volume created by extending the plunger.

12. An automated drug preparation system for preparing in a syringe a final dosage of medication having a concentration X from a medication source that has a concentration Y which is higher than X comprising:

a first fluid delivery station that includes a first automated fluid delivery device that is in fluid communication with a source of a first fluid that is for delivery to the syringe;

an adjustable plunger extension mechanism that includes a movable component that intimately engages a plunger of the syringe so that a first movement of the movable component is translated into a first extension of the plunger a first defined distance which causes a volume A of the first fluid to be drawn into the syringe;

a second fluid delivery station that includes a second automated fluid delivery device that is in fluid communication with the medication source having the concentration Y;

a controller that includes stored medication orders including a final volume and the concentration Y of the final dosage of medication, wherein and based on the stored medication orders, the controller calculates the first defined distance that the plunger is moved to draw the volume A of the first fluid and causes the plunger to extend the first defined distance, wherein the second automated fluid delivery device delivers into the syringe an amount B of the medication source that has the concentration Y, wherein the sum of A+B=Y, wherein delivery of the amounts A and B occur at different times.

13. The system of claim 12, wherein the first fluid is a diluent that is delivered in a pumpless manner to the syringe.

14. The system of claim 12, wherein the controller calculates a second defined distance for extending the plunger to create space for receiving the volume B of the source of medication by means of the second automated fluid delivery device which is located downstream from the first automated drug delivery device, the controller instructing the plunger extension mechanism to extend the second defined distance after the first fluid is disengaged from being in fluid communication with the syringe and prior to delivery of the syringe to the second fluid delivery station.

15. The system of claim 12, wherein the second fluid comprises medication that is reconstituted in a drug vial and then aspirated from the drug vial and injected into the syringe.

16. The system of claim 12, wherein the second automated drug delivery device is configured to perform the following operations:

(1) receiving diluent from a diluent supply in a prescribed amount to reconstitute the medication in the drug vial; and

(2) aspirating and later injecting the reconstituted medication from the drug vial into the syringe.

17. The system of claim 12, wherein the controller compares the sum of A+B to a stored maximum final volume and is the sum is less than the stored maximum final volume, then the amount A of the first fluid and the amount B of the medication source can be directly added to the syringe and if the sum is greater than the maximum final volume, the controller instructs the amount A of the first fluid and the amount B of the medication source to be added to another container where the two are combined to form the diluted medication a prescribed amount of which is later withdrawn from the container and injected into the syringe.

18. An automated drug preparation system for preparing a diluted dosage of medication in a drug delivery device comprising:

an input for entering a drug order;

a plurality of stations including a first station at which drug delivery devices are loaded onto a transportation device that moves the drug delivery devices from one station to another station in a controlled manner;

a storage unit containing a plurality of drug vials including empty drug vials and drug vials containing medication to produce a dosage of medication having a first concentration that is greater than a second concentration of the diluted dosage of medication;

an automated drug preparation device at a second station that executes the drug order and is configured to both deliver fluid and aspirate fluid based on instructions that are contained in a database and associated with the drug order;

a third station that holds one or more partially used vials containing reusable medications;

an inventory of the drug vials in the storage unit; and

a controller that initially assigns a drug vial to each drug delivery device loaded onto the transportation device based on the final concentration of the diluted dosage of medication and the volume of the diluted dosage of medication, the controller being configured to search the inventory of the drug vials and select the drug vial that contains the medication for use in preparing the prescribed dosage and provides a minimum amount of the drug for use in preparing the prescribed dosage and wherein the controller instructs the automated drug preparation device to prepare and deliver the diluted prescribed dosage of medication by using the selected drug vial.

19. The system of claim 18, further including:

a safety check mechanism that prevents the preparation of the prescribed dosage of medication from a previously diluted medication.

20. The system of claim 18, wherein the automated drug preparation device prepares the diluted prescribed dosage of medication by selecting a parent drug vial containing the proper medication and then delivering a prescribed amount of diluent to the parent vial to form a parent medication and aspirating a prescribed amount of the parent medication into a child drug vial into which additional diluent is added to form the diluted prescribed dosage of medication.

21. The system of claim 20, wherein software associated with the controller provides traceability of both the parent vial and child vial in a preparation history log and the system includes an imaging device that takes an image of both the parent vial and the child vial which can be viewed by the user.

22. The system of claim 20, wherein if there is more than a minimum threshold amount of diluted medication in the child vial, the controller instructs a robotic device to deliver the child vial to the third station where the child vial is logged and placed at a prescribed location and stored up to is expiration date.

23. The system of claim 20, wherein the controller is configured to reject the drug order if one or more of the following conditions exists:

(1) a parent vial is not available that can provide the diluted prescribed dosage in a volume that can be injected into the drug delivery device;

(2) no parent vial with the prescribed medication exits;

(3) there are no empty child vials;

(4) a volume of the diluted prescribed dosage of medication is less than a required dose volume for all available products of the specified medication.

24. The system of claim 18, wherein the automated drug preparation device selects a parent drug vial containing parent medication in liquid form in a first concentration and aspirates a prescribed amount of the parent medication into a child vial in which an amount of diluent is added to form the diluted dosage of medication.

25. An automated drug preparation system for preparing a prescribed diluted dosage of medication in a syringe comprising:

a first drug delivery station that includes a first automated drug delivery device that is in fluid communication with a source of a diluent that is for delivery to the syringe;

an adjustable plunger extension mechanism that includes a movable component that intimately engages a plunger of the syringe so that a first movement of the movable component is translated into a first extension of the plunger a first defined distance which causes a first volume of the diluent to be drawn into the syringe;

a second drug delivery station that includes a second automated drug delivery device which reconstitutes medication in a drug vial by adding a volume of diluent to the medication in the drug vial to produce a dosage of medication having a first concentration; and

a controller that includes stored medication orders including a final volume and concentration of the prescribed dosage of medication, wherein and based on the stored medication orders, the controller calculates the first defined distance that the plunger is moved to draw the first volume of the diluent and causes the plunger to extend the first defined distance, the controller calculates the difference between the final volume and the first volume and instructs the second drug delivery device to deliver to the syringe a volume of medication having a first concentration so as to form the prescribed diluted dosage of medication that has a concentration of medication less than the concentration of the reconstituted medication.

26. An automated drug preparation system for preparing a prescribed diluted dosage of medication in a syringe comprising:

a first drug delivery station that includes a first automated drug delivery device that is in fluid communication with a source of a diluent that is for delivery to the syringe;

an adjustable plunger extension mechanism that includes a movable component that intimately engages a plunger of the syringe so that a first movement of the movable component is translated into a first extension of the plunger a first defined distance which causes a first volume of the diluent to be drawn into the syringe;

a second drug delivery station that includes a second automated drug delivery device at which a commercially prepared vial of medication is located; and

a controller that includes stored medication orders including a final volume and concentration of the prescribed diluted dosage of medication, wherein and based on the stored medication orders, the controller calculates the first defined distance that the plunger is moved to draw the first volume of the diluent and causes the plunger to extend the first defined distance, the controller calculates the difference between the final volume and the first volume and instructs the second drug delivery device to deliver to the syringe a volume of medication from the vial of medication so as to form the prescribed diluted dosage of medication that has a concentration of medication less than the concentration of the medication in the vial.