AUTOMATED DRUG PREPARATION APPARATUS INCLUDING AUTOMATED DRUG RECONSTITUTION

• US 20070125442A1
• Filed: 11/01/2006
• Published: 06/07/2007
• Est. Priority Date: 12/03/2002
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Osborne, Joel, Tribble, Dennis, Lefebre, Edward, Khan, Abdul
• Granted Patent: US 7,753,085 B2
• Time in Patent Office: Days
• 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. A method of preparing a diluted dosage of medication with an automated drug preparation system including the steps of:

reconstituting medication in a first vial, in an automated manner, to produce reconstituted medication have a first concentration which is greater than an inputted target concentration of the dosage of medication;

loading a syringe onto a device that controllably delivers the loaded syringe from one station to another station;

fluidly connecting the syringe to a source of diluent;

extending a plunger of the syringe a predetermined distance to draw a first volume of the diluent into the syringe;

advancing the partially filled syringe to another station where a predetermined amount of the reconstituted medication is delivered to the partially filled syringe to produce the dosage of medication that has a concentration at least about equal to the inputted target concentration, wherein the reconstituted medication is delivered to the partially filled syringe in a manner different than drawing fluid by extension of the syringe plunger.

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

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;

wherein the system is configured so that two or more separate drug delivery devices can be acted upon at the same time.

3. The system of claim 2, wherein the plurality of stations includes a first medication preparation station where a first fluid is delivered to one drug delivery device and a second medication preparation station where a second fluid is delivered to another drug delivery device at the same time the first fluid is delivered.

4. The system of claim 3, wherein the first fluid is a diluent that is initially added for diluting the second fluid which contains a drug.

5. The system of claim 3, wherein the drug delivery device comprises a syringe and a first device acts of the one drug delivery device in a manner other than delivering fluid to the one drug delivery device, while a second device simultaneously acts on another drug delivery device by delivering a fluid thereto.

6. The system of claim 2, wherein one of the plurality of stations comprises a weigh station that includes a load cell for measuring a weight of a container that holds the drug from which the dosage of medication is prepared.

7. The system of claim 6, wherein the container comprises a drug vial that includes an amount of solid medication that is later reconstituted and a robotic device grasps the drug vial with grippers and places it on the load cell to obtain a first weight measurement that represents a weight of the vial and the solid medication and after reconstitution of the solid medication, the vial with reconstituted medication is placed on the load cell to obtain a second weight measurement that is compared with the first weight measurement to obtain a weight of the reconstituted drug itself which is then compared with an inputted weight for the reconstituted drug and if the measured weight of the reconstituted drug is not within an acceptable range relative to the inputted weight, then the vial is not advanced to a next station.

8. The system of claim 6, wherein the master controller calculates the amount of diluent added to an empty drug vial by means of the load cell and then calculates the amount of the drug added to the drug vial using a device other than the load cell.

9. The system of claim 7, wherein the robotic device has a first mode of operation in which the vial is shuttled down at a first speed to within a first prescribed distance from a platform of the load cell on which the vial is placed and a second mode of operation in which the vial is moved at a second speed that is significantly less than the first speed until impact between the vial and the platform is registered by a sudden increase in the measured weight at the platform.

10. The system of claim 9, wherein the robotic device is programmed to open the grippers of the robotic device once impact between the vial and the platform is registered and after a predetermined time has lapsed from opening the grippers, software associated with the load cell collects a predetermined number of second weight measurements from the load cell which are used to generate the second weight measurement that is compared to the first weight measurement.

11. The system of claim 2, wherein the plurality of stations are arranged in a housing that can be sealed to the environment and includes a HEPA filtration system that is in communication with a master controller of the system and that has one or more sensors for real-time monitoring of air quality in the housing such that if one detected parameter is outside an acceptable range, the sensor sends an alert signal to the master controller which then notifies the operator of the event.

12. The system of claim 11, wherein the one detected parameter is that the particle count in the housing exceeds a threshold and the master controller is programmed to take remedial action to reduce the particle count in the housing.

13. The system of claim 12, wherein the remedial action is to increase air flow into the housing.

14. The system of claim 11, wherein the master controller is programmed to notify the operator by means at least one of an audio alert, a visual alert, a combination thereof, a wireless text message, and a telephone call.

15. The system of claim 2, wherein one of the stations is a reconstitution station where medication is reconstituted with an automated device by adding a predetermined amount of diluent to a drug vial holding a quantity of solid medication and manipulating the vial to cause the solid medication to go into solution, the mixing being performed by a device that is configured to operate at multiple different speeds and one which possesses different mixing modes.

16. The system of claim 15, wherein the device for mixing includes grippers that are part of a robotic device that is configured to move the drug vial from one location to another location.

17. The system of claim 15, wherein the device for mixing includes a vibratory system and the vial is held in grippers that are part of a robotic device that is configured to move the drug vial from one location to another location.

18. The system of claim 15, wherein the device for mixing comprises a shaker device and the medication is reconstituted by securely retaining the vial in the shaker device without the aid of grippers associated with a robotic device that moves the drug vial from one location to another location.

19. The system of claim 15, wherein the drug delivery device comprises a syringe and the medication is reconstituted by adding the diluent to the drug vial and with a series of pull and push motions of fluid and air caused by movement of a plunger relative to the syringe, reconstitution is achieved.

20. The system of claim 15, wherein the vial is vented as the diluent is added and pressure within the vial is substantially equalized relative to outside by adding the diluent and with a series of pull and push motions of the plunger relative to the syringe, air is either injected or removed from the vial to permit equalization.

21. The system of claim 14, wherein the mixing modes comprises a first mixing mode in which the drug vial is gently inverted to cause a wetting of the solid medication with the diluent and a second mixing mode which is an agitation mode which causes the solid medication to go into solution.

22. The system of claim 21, wherein the automated device has an associated reconstitution database that contains a listing of drug types, with each drug type having associated reconstitution instructions including instructions relating to the first and second mixing modes and time periods for each mode.

23. The system of claim 22, wherein the automated device includes a QA function that enables the reconstituted drug to be tested under prescribed conditions to assure that the instructions stored in the reconstitution database results in the solid medication being placed into solution, the QA function having a reconstitution QA database that permits the operator to enter visual observations of the tested reconstituted drug and if the operator indicates, by entering information that causes an alert signal to be generated, that the solid medication is not fully in solution, then the instructions in the reconstitution database are automatically altered by taking into account the visual observations when the automated device is operating in automatic update mode.

24. The system of claim 2, wherein one of the stations is an automated vial load station where based upon a drug order entered by an operator, one drug vial is selected and delivered to a drug reconstitution station where a predetermined amount of medication is delivered by an automated device to permit solid medication in the vial to go into solution, wherein the vial includes an identification member that uniquely identifies the vial and its contents and another of the stations includes a reader that reads the identification member and compares it with a database and if the read identification member does not match stored identification information in the database, then the vial is not delivered to the drug reconstitution station.

25. The system of claim 24, wherein the identification member comprises a barcode that uniquely identifies the vial and its contents and the reader is one of a barcode scanner, imager and a camera.

26. An automated drug delivery system configured to perform reconstitution of a drug and preparation of a prescribed dosage of medication and delivery to a drug delivery device comprising:

an input for entering a drug order;

a first station that holds a plurality of drug vials, each drug vial containing a solid medication and having an identifier that uniquely identifies the drug vial;

a reader that reads the drug vial identifier and transmits read information to a controller that compares the read identifier with the inputted drug order to confirm whether at least drug identifying information of the inputted drug order matches the read identifier and if so, the drug vial is approved for advancement to a second station; and

an automated drug reconstitution device that is located at the second station and includes a source of diluent and a controllable cannula that is selectively in communication with the source of diluent, the drug reconstitution device operating in first, second and third modes, the first mode being an injection mode where a predetermined amount of diluent is injected through a main conduit into the drug vial for wetting and causing the solid medication to go into solution to form reconstituted medication by agitating the solution, the second mode being an aspiration mode for aspirating a predetermined amount of the reconstituted medication into the main conduit where it is held, the third mode being an injection mode where the predetermined amount of aspirated reconstituted medication, which represents the prescribed dosage of medication, is injected through the main conduit into the drug delivery device.

27. The system of claim 26, wherein the automated drug reconstitution device introduces an air bubble into the main conduit prior to operating in the second mode and aspirating the reconstituted medication, wherein the air bubble provides a buffer between the diluent contained in the main conduit and the reconstituted medication that is aspirated during the second mode so as to prevent mixing between the diluent and the reconstituted medication both of which are contained in the main conduit.

28. The system of claim 27, wherein after the automated drug reconstitution device operates in the third mode, the air bubble is located at a distal tip of the main conduit signifying that the prescribed dosage of medication has been delivered into the drug delivery device.

29. The system of claim 26, wherein the second mode of the automated drug reconstitution device operates at a first aspiration phase where the reconstituted medication is aspirated at a first speed and for a first time period and a second aspiration phase in which the reconstituted medication is aspirated at a second speed for a second time period.

30. The system of claim 29, wherein the first speed is greater than the second speed and operation in the first aspiration phase results in a first volume of medication being aspirated and operation in the second aspiration phase results in a second volume of medication being aspirated, the first volume being substantially greater than the second volume.

31. The system of claim 26, further including a master controller that has a database that stores information about each drug vial including material characteristics of a septum of the drug vial, the master controller adjusting a speed of insertion of the cannula through the septum.

32. The system of claim 30, wherein the vial is tilted a prescribed number of degrees during the second aspiration phase.

33. An automated drug delivery system configured to perform reconstitution of a drug and preparation of a prescribed dosage of medication and delivery to a drug delivery device comprising:

an input for entering a drug order;

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

a first station that holds a plurality of drug vials, each drug vial containing a solid medication and having an identifier that uniquely identifies the drug vial;

a reader that reads the drug vial identifier and transmits read information to a controller that compares the read identifier with the inputted drug order to confirm whether at least drug identifying information of the inputted drug order matches the read identifier and if so, the drug vial is approved for advancement to a second station; and

an automated drug reconstitution device that is located at the second station and includes a controller that is in communication with the reconstitution database so that once the drug order is inputted and the reconstitution instructions are retrieved, the controller instructs the automated drug reconstitution device so that the prescribed dosage of medication is prepared and delivered to the drug delivery device in an automated manner and the drug delivery device itself is identified with a unique identifier which is linked to the drug order for the prescribed dosage of medication contained in the drug delivery device and permits tracking of the drug delivery device from station to station.

34. The system of claim 33, wherein the automated drug delivery device includes a source of diluent and a controllable cannula that is selectively in communication with the source of diluent, the drug reconstitution device operating in first, second and third modes, the first mode being an injection mode where a predetermined amount of diluent is injected through a main conduit into the drug vial for wetting and causing the solid medication to go into solution to form reconstituted medication by agitating the solution, the second mode being an aspiration mode for aspirating a predetermined amount of the reconstituted medication into the main conduit where it is held, the third mode being an injection mode where the predetermined amount of aspirated reconstituted medication, which represents the prescribed dosage of medication, is injected through the main conduit into the drug delivery device.

35. The system of claim 34, wherein the reconstitution database includes aspiration instructions including the number, length and characteristics of agitation phases and motions.

36. The system of claim 33, wherein the controller calculates a number of fluid transfers that are needed to deliver the prescribed dosage to the drug delivery device.

37. A method of preparing a diluted dosage of medication with an automated drug preparation system including the steps of:

reconstituting medication in a first vial, in an automated manner, to produce reconstituted medication;

loading a syringe onto a device that controllably delivers the loaded syringe from one station to another station;

extending a plunger of the syringe a predetermined distance to create a first volume in the syringe; and

advancing the partially filled syringe to where a predetermined amount of the reconstituted medication, that is less than the first volume, is delivered into the syringe to produce the dosage of medication.

38. The method of claim 37, wherein the reconstituted medication is delivered to the syringe in a manner different than drawing fluid by further extension of the syringe plunger.