Automated drug preparation apparatus including drug reconstitution

• US 8,220,503 B2
• Filed: 03/04/2010
• Issued: 07/17/2012
• Est. Priority Date: 12/03/2002
• Status: Expired due to Term

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: FHT, Inc. (Baxter International Inc.)
• Inventors: Tribble, Dennis, Osborne, Joel A., Khan, Abdul Wahid, Lefebre, Edward J.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US12/717,488
• Publication Number:
  US 20100161113A1
• Time in Patent Office: 866 Days
• Field of Search: 141/2, 141/18, 141/98, 141 21- 27, 141/9, 141100-104, 604/407, 604/411, 604/416
• US Class Current: 141/27
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 2200/74 for weight
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04
• CPC Class Codes: B65C 3/06 Affixing labels to short rigid containers
• CPC Class Codes: B65C 3/26 Affixing labels to non-rigid containers, e.g. bottles made of polyethylene, boxes to be inflated by internal air pressure prior to labelling

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 medication preparation system having a plurality of stations comprising:

a drug cabinet containing a plurality of drug vials each containing a respective medication and having identifying information associated therewith that relates to the contained medication, wherein a specific drug vial is retrieved from the drug cabinet in accordance with a request based on information inputted into the system;

an identifying station for identifying the specific drug vial retrieved from the drug cabinet as being a multi-use injectable medication vial containing a multi-use medication based on information inputted into the system;

a database in which a vial that has been identified as being a multi-use injectable medication vial is marked;

a medication preparation station where a dosage of medication is prepared in a just-in-time manner using an identified drug vial;

a holding station for storing multi-use injectable medication vials, the contents of which have been previously accessed for preparing the dosage of medication at the medication preparation station and that have been cataloged according to prescribed criteria to permit later use in preparing another dosage of medication at the medication preparation station; and

an automated transfer device for transferring the vial that has been identified and marked as being a multi-use injectable medication vial from one station to the holding station, wherein the automated transfer device receives and holds more than one vial and moves the vials in a controlled manner from one station to another station;

wherein two or more vials can be acted upon at the same time in different stations.

2. An automated medication preparation system having a controller and a plurality of stations for processing inputted drug orders and preparing prescribed dosages of medication comprising:

a drug cabinet containing a plurality of drug vials each containing a respective medication and having identifying information associated therewith that relates to the contained medication, wherein a specific drug vial is retrieved from the drug cabinet in accordance with a request based on information inputted into the system, wherein the drug vials include at least one vial having a solid medication;

an identifying station for identifying the specific drug vial retrieved from the drug cabinet as being a multi-use injectable medication vial containing a multi-use medication based on information inputted into the system;

a database in which a vial that has been identified as being a multi-use injectable medication vial is marked;

a reconstitution database that includes detailed instructions on how to reconstitute the drug identified by one respective drug order;

a medication preparation station where a dosage of medication is prepared in a just-in-time manner using an identified drug vial, the medication preparation station including a drug reconstitution device that is in communication with the reconstitution database so that once a drug order is inputted and identified as being a reconstituted drug order, reconstitution instructions are received and the controller subsequently instructs the drug reconstitution device so that the prescribed dosage of medication is prepared in accordance with the reconstitution instructions;

a holding station for storing multi-use injectable medication vials, the contents of which have been previously accessed for preparing the dosage of medication at the medication preparation station and that have been cataloged according to prescribed criteria to permit later use in preparing another dosage of medication at the medication preparation station; and

an automated transfer device for transferring the vial that has been identified and marked as being a multi-use injectable medication vial from one station to the holding station.

3. The system of claim 2, wherein the medication preparation station includes an automated device including automated syringe preparation including reconstitution of the medication and delivery of the reconstituted medication to a syringe.

4. The system of claim 2, further including:

a detector that determines whether the vial is in an upright orientation or is in an opposite inverted orientation relative to ground throughout one or more stations of the robotic application;

wherein the identifying station identifies the retrieved vial prior to the retrieved vial being automatically advanced to the detector, the retrieved vial being identified based on a comparison between the identifying information associated therewith and stored vial identifying information for the specific drug vial that is expected to have been retrieved from the drug cabinet.

5. The system of claim 4, wherein the vial includes a magnetic chip attached thereto at one end and the detector comprises a detector that is capable of detected a change in a surrounding magnetic field such that when the vial is in a correct orientation, the magnetic chip of the vial influences the detector and causes it to generate a control signal indicating that the vial is in the correct orientation and can be advanced to a next station, wherein if the retrieved vial is not in a correct orientation, the detector sends a control signal that causes the vial to be removed from the robotic application.

6. The system of claim 4, wherein the vial includes an optical marker and the detector comprises an optical detector that is capable of detecting the optical marker such that when the vial is in a correct orientation, the detector recognizes the optical marker of the vial and generates a control signal that indicates that the vial is in the correct orientation and can be advanced to a next station.

7. The system of claim 4, wherein the detector is positioned at a location prior to a station where medication contained in the vial is reconstituted using a cannula unit that includes a cannula extending therefrom that pierces a septum of a decapped vial.

8. The system of claim 4, wherein if the vial is not in a correct orientation, the detector sends a control signal that causes the vial to be removed from the respective station.

9. The system of claim 4, wherein the detector is present at a station where the vial is placed on a rotatable pedestal and is positively identified by scanning equipment, the detector serving to determine whether the vial is placed upright on the pedestal prior to the vial gripper device engaging and removing the vial therefrom for delivery to the next station.

10. The system of claim 4, wherein a cap end of the medication vial includes a member attached thereto, the detector being configured and positioned so that when the vial is properly orientated, the member lies within a scope of field of the detector and the detector detects the member and generates a control signal indicating that the vial is properly orientated and should be advanced to a next station.

11. The system of claim 10, wherein the member is selected from the group consisting of an optical marker, a magnetic chip, and a scannable tag attached to the vial and the detector is a reader such that if and when the scannable tag passes through a beam of the detector, the detector reads the tag and generates a control signal indicating that the vial is in the proper orientation and should be advanced to the next station.

12. The system of claim 2, wherein the medication vial is partially filled with an amount of medication that is left after preparing the dosage of medication and the holding station has a support surface that is divided into a grid with distinct coordinates so that each medication vial can be inventoried and placed at a selected coordinate location.

13. The system of claim 2, further including

a controller in communication with the medication preparation station and with the transfer device, wherein when a dosage of medication is to be prepared at the medication preparation station, the controller is configured to operate by checking first whether one of the medication vials at the holding station contains the medication needed to prepare the dosage of medication and if so, the respective medication vial is transferred from the holding station to permit the dosage of medication to be prepared;

and

a device for confirming the contents of the medication vial that is received from the holding station prior to the contents being removed for preparing a dosage of medication.

14. The system of claim 2, wherein the multi-use vials are labeled as multi-use medications that can be reused.

15. The system of claim 2, wherein the multi-use vials are identifiable independent of information related to the holding station using the marked information in the database.

16. A method for handling multi-use medication vials in an automated medication preparation system comprising the steps of:

identifying a vial as a multi-use vial based on information input into the system;

marking the vial identified as the multi-use vial in a database;

retrieving a specific first multi-use medication vial from a source in accordance with a request based on information inputted into the system;

delivering the specific, first multi-use vial to a medication preparation station;

transferring from the delivered vial a predetermined amount of content and preparing, in a just-in-time manner, a dosage of medication from the predetermined amount, wherein the predetermined amount is less than 100% of its contents; and

delivering the first medication vial to a holding station that is configured to store a plurality of multi-use medication vials, the contents of which have been previously accessed for preparing the dosage of medication at the medication preparation station but still contain contents that can be used in preparing another dosage of medication, the multi-use vial being identifiable independent of information related to the holding station.

17. The method of claim 16, further including the steps of:

cataloging the first medication vial at the holding station according to prescribed criteria to permit later use of its contents in preparing another dosage of medication at the medication preparation station.

18. The method of claim 17, wherein the step of cataloging the first medication vial comprises the step of:

dividing the holding station into a grid with distinct coordinates so that each medication vial can be inventoried and placed at a selected coordinate location and later retrieved therefrom based on its coordinate location.

19. The method of claim 16, further including the step of:

confirming the contents of the first medication vial subsequent to it being removed from the holding station but prior to removal of the contents for preparing another dosage of medication.

20. The method of claim 16, further including the step of:

detecting whether the medication vial is in an upright orientation or is in an opposite inverted orientation relative to ground throughout one or more stations of the system.

21. The method of claim 20, further including the step of:

discarding the vial if after a predetermined time period, the vial is not detected as being in the proper orientation.

22. The method of claim 20, wherein the step of detecting the orientation of the retrieved vial includes the step of:

detecting a change in a magnetic field surrounding the detector such that when the vial is in the upright orientation, a magnetic chip attached to the vial influences the detector and causes it to generate a control signal indicating that the vial is in a correct orientation and can be advanced to a next station, wherein if the retrieved vial is not in a correct orientation, a control signal is sent causing the vial to be removed from the robotic application.

23. The method of claim 20, wherein the step of detecting the orientation of the retrieved vial includes the step of:

optically detecting a marker that is attached to the vial such that when the vial is in the upright orientation, the detector reads the optical marker of the vial and generates a control signal that indicates that the vial is in a correct orientation and can be advanced to a next station, wherein if the retrieved vial is not in a correct orientation, a control signal is sent causing the vial to be removed from the robotic application.

24. The method of claim 20, wherein the step of detecting the orientation of the vial includes the step of:

reading a scannable tag that is attached to the vial such that when the vial is in the upright orientation, the detector scans and reads the tag of the vial and generates a control signal that indicates that the vial is in a correct orientation and can be advanced to a next station.