Automated apparatus and process for reconstitution and delivery of medication to an automated syringe preparation apparatus

• US 6,915,823 B2
• Filed: 12/03/2003
• Issued: 07/12/2005
• 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 A., Tribble, Dennis
• Primary Examiner(s): Douglas, Steven O.
• Application Number:
  US10/728,364
• Publication Number:
  US 20040154690A1
• Time in Patent Office: 587 Days
• Field of Search: 141/2, 141/18, 141 21- 27, 141/94, 141/100, 141/104, 604/407, 604/411, 604/416
• US Class Current: 141/27
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 33/85 Mixing plants with mixing receptacles or mixing tools that can be indexed into different working positions
• 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

Abstract

In one exemplary embodiment, an automated medication preparation system including automated syringe preparation that involves reconstitution of the medication is provided. The system includes: (1) a first automated gripping means for removing a tip cap from a barrel of one syringe and placing the removed tip cap at a first location; (2) an automated device for delivering a prescribed dosage amount of medication to the syringe by delivering the medication through the uncapped barrel in a just-in-time for use manner; (3) a controller in communication with the automated device and including a database for storing reconstitution information that is executable with the automated device for reconstituting the medication prior to it being injected into the syringe, wherein the reconstitution information include at least a concentration of the resultant medication and a mixing time for agitating the medication; and (4) a second automated gripping means for replacing the removed tip cap on the syringe barrel after the medication is injected therein.

Claims

1. An automated medication preparation system including automated syringe preparation including reconstitution of the medication, the system comprising:

a first automated gripping means for removing a tip cap from a barrel of one syringe and placing the removed tip cap at a first location;

an automated device for delivering a prescribed dosage amount of medication to the syringe by delivering the medication through the uncapped barrel in a just-in-time for use manner;

a controller in communication with the automated device and including a database for storing reconstitution information that is executable with the automated device for reconstituting the medication prior to it being injected into the syringe, wherein the reconstitution information include at least a concentration of the resultant medication and a mixing time for agitating the medication; and

a second automated gripping means for replacing the removed tip cap on the syringe barrel after the medication is injected therein.

2. The automated system of claim 1, wherein each of the first and second automated gripping means comprises a robotic device having first and second gripping arms that are spaced apart from one another in a first position and are moved toward one another to a second position so as to securely capture and hold the tip cap between the first and second gripping arms.

3. The automated system of claim 2, wherein the robotic device is movable at least along an x axis and a y axis.

4. The automated system of claim 1, further including:

an automated device for extending a plunger of the syringe barrel.

5. The automated system of claim 4, wherein the automated device is operatively connected to a control unit which instructs the automated device to extend the plunger a predetermined distance based on the prescribed amount of medication.

6. The automated system of claim 1, further including an automated rotary device that is indexed to advance the syringe from one station to another station, the rotary device having a first feature formed as part thereof for releasably retaining the syringe and a second feature for holding the removed tip cap as the syringe is advanced from one station to the next.

7. The automated system of claim 1, wherein the automated device for delivering a prescribed dosage amount of medication to the syringe comprises an automated robotic device that operates in accordance with signals received from the controller and includes a cannula unit that is rotatably mounted to a vertical base which is itself rotatably mounted to a lower ground base, wherein the cannula unit includes a cannula extending thereaway for performing at least one of the following operations:

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

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

8. The automated system of claim 7, wherein the cannula is fluidly connected to a main conduit that is selectively connected at its opposite end to the diluent source and to a means for creating either negative pressure or positive within the main conduit for aspirating fluid into the main conduit or discharging fluid therefrom, respectively.

9. The automated system of claim 8, wherein the means comprises:

a collection member for storing diluent received from either the diluent source or diluent that is drawn into the collection member from a downstream section of the main conduit; and

a control unit and a valve mechanism that are operatively connected to the collection member to create negative pressure therein to drawn fluid therein or to create positive pressure to force fluid to be discharged therefrom.

10. The automated system of claim 9, wherein the collection member comprises:

a first syringe having a barrel with an interior having a first volume; and

a second syringe having a barrel with an interior having a second volume;

wherein each of the first and second syringes having a slideable plunger contained in the respective barrel and each syringe being in selective fluid communication with each of the diluent source and the main conduit that leads to the cannula.

11. The automated system of claim 10, wherein the first volume is at least 50% greater than the second volume.

12. The automated system of claim 10, wherein the control unit comprises:

a first syringe driver associated with the first syringe for selectively moving the plunger a prescribed distance;

a second syringe driver associated with the second syringe for selectively moving the plunger a prescribed distance; and

the valve mechanism includes a first valve for providing selective fluid communication between the control unit and the diluent source and a second valve for providing selective fluid communication between the control unit and the downstream section of the main conduit.

13. The automated system of claim 12, wherein the first and second syringes are fluidly interconnected by a connector conduit that has a valve associated therewith for permitting selective flow between the syringes.

14. The automated system of claim 12, wherein at least one of the first and second syringes has an input port and an output port with the input port being connected to a first conduit that connects at its opposite end to the diluent source with a valve being associated with the first conduit to provide selective communication between the diluent source and the input port, the output port being connected to a second conduit that connects at its opposite end to the main conduit with a valve being associated with the second conduit to provide selective communication between the output port and the main conduit.

15. The automated system of claim 12, wherein each of the first and second syringe drivers comprises a stepper motor that operates such that an incremental distance of movement of the plunger is equated to a number of steps through which the motor is driven, thereby permitting precise control over the exact distance that the plunger is moved.

16. The automated system of claim 9, wherein the main conduit is primed with diluent fluid such that the diluent fluid is present along at least a substantial length of the main conduit and the control unit operates so that the prescribed amount of medication is drawn into a distal end of the main conduit with an air block being present between the medication drawn into the main conduit and the diluent that is also present in the main conduit, the control unit operating to discharge the medication by introducing a volume of diluent into the main conduit that equals the volume of the medication that is discharged therefrom.

17. The automated system of claim 16, further including:

a mixing device for agitating the vial with the medication and injected diluent so that the desired reconstituted medication is produced, the mixing device in communication with the central processor unit which instructs the mixing device to be actuated for the stored mixing time.

18. The automated system of claim 17, wherein the mixing device is a vortex mixer.

19. The automated system of claim 17, wherein the mixing device is an automated vibrating device having a platform that receives the vial and an adjustable hold down bar that is manipulated so that it travels towards the vial and engages the vial at an end opposite the platform such that once the vial is securely captured between the platform and hold down bar, vibrating device is actuated resulting in the vial being shaken to agitate the medication and ensure that all of the medication properly goes into solution.

20. The automated system of claim 1, further including:

a multi-use medication station where drug vials that are identified as multi-use medication vials are stored after the medication is reconstituted therein and the prescribed dosage amount is aspirated therefrom by the cannula unit.

21. The automated system of claim 20, further including:

an automated vial gripper device for retrieving and securely holding a selected vial containing the medication from a first location and transferring it to a plurality of stations downstream of the first location, the automated vial gripper device being capable of moving in the x, y, and z directions and inverting the held vial, wherein the vial gripper device delivers vials that are identified as multi-use to the multi-use station after the prescribed dosage amount is aspirated and when reconstituted medication remains in the vial.

22. The automated system of claim 7, wherein the cannula comprises a vented cannula that is selectively vented to atmosphere.

23. The automated system of claim 7, wherein the cannula comprises an automated cannula that includes a tip that is movable within a vial that holds the medication to permit all of the medication to be drawn from the vial.

24. An automated medication preparation system including automated syringe preparation including reconstitution of the medication and delivery of the reconstituted medication to a syringe, the system comprising:

an automated device for delivering a prescribed dosage amount of medication to the syringe by injecting the medication through an uncapped barrel in a just-in-time for use manner;

a controller in communication with the automated device and including a database for storing reconstitution information that is used to control the automated device for reconstituting the medication prior to it being injected into the syringe, wherein the reconstitution information include at least a concentration of the resultant medication and a mixing time for agitating the medication; and

wherein the automated device for delivering a prescribed dosage amount of medication to the syringe comprises an automated robotic device having a cannula unit that is rotatably mounted to a vertical base which is itself rotatably mounted to a lower ground base, wherein the cannula unit includes a cannula extending thereaway for performing at least one of the following operations;

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

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

25. An automated medication preparation system including automated syringe preparation including delivery of a prescribed amount of medication to the syringe, the system comprising:

a source of medication;

a first conduit connected at one end to the source of medication and at the other end to an input port of a pump that has an output port that is connected to a second conduit that terminates at its other end in a connector;

an automated rotary device that is indexed to advance one syringe from one station to another station, the rotary device having a feature formed as part thereof for releasably retaining the syringe;

an automated device for extending a plunger of a syringe barrel positioned at a fluid transfer position of the rotary device, the automated device being operatively connected to a control unit which instructs the automated device to extend the plunger a predetermined distance based on the prescribed amount of medication; and

wherein the connector sealingly mates with an open end of the syringe barrel so that extension of the plunger creates a negative pressure condition within the barrel and results in the prescribed amount of medication being drawn therein from the second conduit.

26. The automated system of claim 25, wherein the source of medication comprises a bag filled with liquid medication.

27. The automated system of claim 25, wherein the pump is a peristaltic pump that selectively pumps medication from the source into the second conduit.

28. An automated medication preparation system including automated syringe preparation comprising:

an automated injectable drug vial delivery assembly that identifies and transfers one drug vial from a storage location to a fluid transfer station by means of a robotic vial gripper device;

an automated device disposed at the fluid transfer station for delivering a prescribed dosage amount of medication to an uncapped syringe by delivering the medication through the uncapped barrel in a just-in-time for use manner; and

a multi-use medication station where drug vials that are identified as multi-use medication vials are stored after the prescribed dosage amount of the medication is withdrawn from the vial and an unused amount remains therein, wherein the vial is delivered to the multi-use medication station by means of the robotic vial gripper device and is available for later use when another syringe requiring the medication contained in the vial is prepared.

29. A method for automated preparation of a medication including automated syringe preparation that includes reconstitution of the medication and delivery of the reconstituted medication to a syringe, the method comprising the steps of:

providing an automated device for delivering a prescribed dosage amount of medication to the syringe by injecting the medication through an uncapped barrel in a just-in-time for use manner;

inputting medication identifying information for identifying the medication that is to be prepared for use;

accessing and retrieving stored reconstitution instructions from a database that is associated with the inputted medication identifying information, the reconstitution instructions being for controlling the automated device for reconstituting the medication prior to it being injected into the syringe, wherein the reconstitution instructions include at least a concentration of the resultant medication and a mixing time for agitating the medication; and

reconstituting the medication, in accordance with the stored reconstitution instructions, in vial with an automated robotic device having a rotatable cannula unit by first discharging a prescribed amount of diluent through the cannula unit into the vial;

then agitating the medication in the vial, then aspirating and later discharging the prescribed dosage amount of medication from the vial into the syringe in a just-in-time for use manner.

30. The method of claim 29, wherein the cannula unit is in selective fluid communication with a fluid pump apparatus that is in selective fluid communication with a diluent source, the fluid pump apparatus having a first controllable syringe that is in fluid communication with the diluent source and with a second controllable syringe that is also in selective fluid communication with the cannula unit through a primed main conduit, each of the syringes being operably connected to a drive that causes either a positive or negative pressure to exist in a barrel thereof, and the step of reconstituting the medication includes the steps of:

opening fluid communication between the diluent source and the first syringe and preventing fluid communication between the second syringe and the cannula unit;

operating a drive of one of the first and second syringes to create a negative pressure therein resulting in a prescribed amount of diluent being drawn into the barrel thereof;

preventing fluid communication between the diluent source and the first syringe and allowing fluid communication between the second syringe and the cannula unit;

operating the drive so as to discharge the prescribed amount of diluent from one of the first and second syringes into the primed main conduit resulting in the prescribed amount of diluent being discharged through the cannula and into the vial;

agitating contents of the vial;

operating a drive of one of the first and second syringes to create a negative pressure therein resulting in the prescribed dosage amount of medication being aspirated into the main conduit with an air block separating the aspirated medication from the diluent in the main conduit due to a volume of diluent, which is equal to the prescribed dosage amount, be drawn into the syringe barrel;

positioning the cannula within the syringe; and

operating the drive of one of the first and second syringes to create a positive pressure therein resulting in the prescribed dosage amount of medication being discharged from the main conduit into the syringe as a result of the volume of diluent being discharged from the syringe into the main conduit.