Automated pharmacy admixture system (APAS)

• US 7,610,115 B2
• Filed: 12/22/2005
• Issued: 10/27/2009
• Est. Priority Date: 12/22/2004
• Status: Active Grant

• Current Assignee: ArXium, Inc. (Van Humbeck Family)
• Original Assignee: Intelligent Hospital Systems, Inc. (Van Humbeck Family)
• Inventors: Eliuk, Walter W., Rob, Ronald H., Mlodzinski, Lance R.
• Primary Examiner(s): Tran; Khoi
• Assistant Examiner(s): SAMPLE, JONATHAN L
• Application Number:
  US11/316,795
• Publication Number:
  US 20060136095A1
• Time in Patent Office: 1,405 Days
• Field of Search: 700/245, 700/213, 700/177, 700/216, 700/239, 318567-56825
• US Class Current: 700/245
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• 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 31/024 specially adapted for wrappers or bags B65B31/021, B65B31/022 take precedence
• CPC Class Codes: G07F 11/165 using xyz-picker or multi-dimensional article picking arrangements
• CPC Class Codes: G07F 11/44 in which magazines the articles are stored in bulk
• CPC Class Codes: G07F 11/48 the storage containers or supports, e.g. magazine, being pivotally mounted
• CPC Class Codes: G07F 11/54 about vertical axes
• CPC Class Codes: G07F 11/62 in which the articles are stored in compartments in fixed receptacles
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

An Automated Pharmacy Admixture System (APAS) may include a manipulator that transports medical containers such as bags, vials, or syringes about a substantially aseptic admixing chamber. In a preferred implementation, a gripper assembly is configured to substantially universally grasp and retain syringes, IV bags, and vials of varying shapes and sizes. In an illustrative embodiment, a gripping device may include claws configured to grasp a plurality of different types of IV bags, each type having a different fill port configuration. Embodiments may include a controller adapted to actuate a transport assembly to place a fill port of the bag, vial or syringe into register with a filling port such as a cannula located at a filling station, or be equipped with carousel transport systems that are adapted to convey bags, vials, and syringes to the admixture system and deliver constituted medications in bags, vials or syringes to an egress area.

Claims

1. An automated pharmacy admixture system, comprising:

a carrier system to present a plurality of IV bags to a location proximate or within a first substantially aseptic zone, wherein the carrier system is substantially disposed in a second substantially aseptic zone, wherein a pressure within the first aseptic zone is negative relative to ambient atmospheric pressure;

a manipulator system to transport items within the first substantially aseptic zone;

a fluid transfer system disposed at least substantially within the first substantially aseptic zone, the fluid transfer system comprising a fluid transfer port to transfer fluids to or from IV bags; and

a controller comprising a processor to receive instructions that, when executed by the processor, cause the processor to perform operations comprising;

actuating the manipulator system to bring a fill port of an IV bag and the fluid transfer port into register with one another, and

actuating the manipulator system to move the IV bag and the fluid transfer port out of register after a fluid transfer operation.

2. An automated pharmacy admixture system comprising:

a supply of IV bags, each bag having at least one of a plurality of different fill port configurations;

a substantially aseptic chamber comprising at least one fluid transfer station configured to transfer fluids into or out of an IV bag, wherein a pressure inside the substantially aseptic chamber is negative relative to ambient atmospheric pressure;

a carrier that delivers the supply of IV bags to a location proximate the substantially aseptic chamber; and

an actuator to convey the IV bags to one or more of the fluid transfer stations within the chamber.

3. An automated pharmacy admixture system, comprising:

a carrier system comprising a rotating carousel to present a plurality of different types of medical containers to a location proximate or within a first substantially aseptic zone that is controlled to maintain a pressure level negative relative to ambient atmospheric pressure, wherein the plurality of different types of medical containers comprise items selected from the group consisting of syringes, IV bags, and vials, and wherein the carrier system is substantially disposed in a second substantially aseptic zone;

a robotic manipulator system to handle the plurality of different types of medical containers within the first substantially aseptic zone;

a fluid transfer system disposed at least substantially within the first substantially aseptic zone, the fluid transfer system comprising a fluid transfer port to transfer fluids to or from the medical containers; and

a controller comprising a processor to receive instructions that, when executed by the processor, cause the processor to perform operations comprising;

actuating the robotic manipulator system to transfer an IV bag or vial to the fluid transfer system;

bringing a fill port of the IV bag or vial and the fluid transfer port into register with one another;

moving the fill port and the fluid transfer port out of register after a fluid transfer operation; and

actuating the robotic manipulator system to remove the IV bag or vial from the fluid transfer system.

4. The system of claim 3, wherein the rotating carousel comprises at least one device to releasably retain a fill port of an IV bag.

5. The system of claim 4, wherein the retaining device comprises a clip.

6. The system of claim 3, wherein the rotating carousel is configured to hold different sizes or shapes of syringes, IV bags, and vials.

7. The system of claim 3, wherein a pressure in the first substantially aseptic zone is regulated to a pressure level substantially below ambient pressure.

8. The system of claim 7, wherein the pressure level in the first substantially aseptic zone is between about 0.1 and about 10 inches of water below ambient pressure.

9. The system of claim 3, wherein the second substantially aseptic zone is regulated to a pressure level substantially above or below ambient pressure.

10. The system of claim 9, wherein the pressure level in the second substantially aseptic zone is higher than the first substantially aseptic zone.

11. The system of claim 3 further comprising a UV (ultraviolet) sanitization system to sanitize at least a portion of the fill port of the IV bag or vial.

12. The system of claim 3, wherein the fluid transfer system is configured to inject a predetermined amount of air into a vial to facilitate the withdrawal of fluid from the vial.

13. The system of claim 3, wherein the fluid transfer port comprises a port of a needle on a syringe and is coupled to exchange fluid with a medical container while the needle is oriented substantially upward.

14. The system of claim 3, wherein the fluid transfer port comprises a port of a needle on a syringe and is coupled to exchange fluid with a medical container while the needle is oriented substantially downward.

15. The system of claim 3 further comprising an ID station to identify medical containers so as to confirm that a medical container being handled by the robotic manipulator system is the appropriate medical container for a selected operation.

16. The system of claim 3 further comprising a weighing station to weigh medical containers to confirm that that a predetermined amount of fluid has been transferred to or from the containers.

17. The system of claim 3 further comprising a needle decapping station to automatically remove needle caps in preparation for a compounding operation.

18. The system of claim 3 further comprising a needle removing station to automatically remove a needle from a syringe after the syringe has been loaded with a desired quantity of medication.

19. The system of claim 18 further comprising a syringe capping station to place a cap on the syringe after the needle has been removed.

20. The system of claim 3 further comprising a manual loading station where an operator loads medical containers onto the carrier system.

21. An automated pharmacy admixture system, comprising:

a processing chamber that provides a substantially aseptic environment for a preparation of one or more pharmaceutical doses, wherein the system is configured to maintain a pressure level inside the processing chamber that is substantially below an atmospheric pressure level proximate and exterior to the processing chamber to substantially reduce an egress of chemicals from inside the processing chamber to outside the processing chamber;

an inventory chamber exterior and adjacent to the processing chamber for storing within an interior of the inventory chamber a plurality of inventory items to be used in the preparation of one or more pharmaceutical doses, wherein the plurality of inventory items comprises at least one container of diluent, at least one medication container including medication, and at least one syringe, each of the at least one syringes comprising a plunger disposed within a first end of a barrel and a needle coupled to a second opposite end of the barrel, wherein the inventory chamber substantially encloses the plurality of inventory items in an environment substantially separate from an ambient environment outside of the inventory chamber;

a rotatable inventory carousel disposed in the inventory chamber and rotatable around a vertical axis, the inventory carousel operable to support the plurality of inventory items;

an exterior access portal in a side of the inventory chamber, wherein the exterior access portal is operable from a closed position to an open position to provide an operator access to the plurality of inventory items stored within the inventory chamber;

a multiple degree of freedom robotic arm disposed within the processing chamber and configured to reach into the inventory chamber, retrieve an inventory item being supported by the inventory carousel, present the inventory item to a first process location in the processing chamber, release the inventory item for processing at the first process location, and subsequently retrieve the inventory item and convey the inventory item to a second process location;

an opening defined in a side between the inventory chamber and the processing chamber wherein the opening is arranged to permit the robotic arm to reach through the opening and grasp a selected inventory item supported by the inventory carousel within the inventory chamber;

a syringe manipulator station within the processing chamber that is configured to hold the syringe;

a waste container situated to receive processed inventory items from the robotic arm; and

a controller that is configured to cause steps to be performed to prepare a pharmaceutical dose in an output container, the steps comprising;

(a) selecting at least one of each of the at least one syringe, the at least one diluent container, and the at least one medication container to be used to prepare an output container that comprises a pharmaceutical dose;

(b) rotating the inventory carousel to at least one position to make at least one of the selected syringe, the selected diluent container, and the selected medication container accessible by the robotic arm as the robotic arm reaches through the opening;

(c) conveying the selected syringe and the selected diluent container to the syringe manipulator station using the robotic arm;

(d) registering the needle of the selected syringe with a port of the selected diluent container and drawing diluent from the selected diluent container into the selected syringe;

(e) conveying the selected medication container to the syringe manipulator station using the robotic arm; and

(f) registering the needle of the selected syringe with a port of the selected medication container to inject at least a portion of the diluent that was drawn into the syringe in order to reconstitute the medication in the selected medication container.

22. The automated pharmacy admixture system of claim 21, wherein the steps further comprise rotating the inventory carousel to make each of the selected syringe, the selected diluent container, and the selected medication container accessible by the robotic arm as the robotic arm reaches through the opening.

23. The automated pharmacy admixture system of claim 21, wherein the waste container is disposed in a chamber disposed beneath the processing chamber.

24. The automated pharmacy admixture system of claim 21, wherein the container of diluent comprises an IV bag.

25. The automated pharmacy admixture system of claim 24, further comprising an IV bag holding station adapted to receive the IV bag from the robotic arm and operable to rotate between a first position configured to support the received IV bag with a port of the IV bag directed substantially upwards, and a second position configured to support the received IV bag with the port of the IV bag directed substantially downwards, wherein the IV bag holding station is further adapted to register the port of the IV bag with the needle of the syringe held by the syringe manipulator station while the IV bag station is in either the first position or the second position.

26. The automated pharmacy admixture system of claim 25, wherein the robotic arm is adapted to convey the IV bag to an egress area after the IV bag has been processed to include a reconstituted medication.

27. The automated pharmacy admixture system of claim 21, wherein the robotic arm is adapted to convey the syringe to an egress area after the syringe has been processed to include a reconstituted medication.

28. The automated pharmacy admixture system of claim 21, wherein the medication container comprises a vial.

29. The automated pharmacy admixture system of claim 21, wherein the inventory chamber comprises an inventory monitoring system that includes a barcode scanner arranged to monitor position information about at least one of the plurality of inventory items supported by the inventory carousel by scanning one or more barcodes coupled to the inventory carousel and associated with at least one of the inventory items supported by the inventory carousel.

30. The automated pharmacy admixture system of claim 21, wherein the syringe stored within the interior of the inventory chamber further comprises a needle cap covering the needle.

31. The automated pharmacy admixture system of claim 30, further comprising a needle decapper station at which the system operates to separate the needle cap from the syringe.

32. The automated pharmacy admixture system of claim 21, wherein the first process location or the second process location comprises a weight scale for measuring a weight of the retrieved inventory item.

33. The automated pharmacy admixture system of claim 21, wherein the first process location or the second process location comprises the syringe manipulator station.

34. The automated pharmacy admixture system of claim 21, wherein the steps further comprise rotating the inventory carousel to make at least two of the selected syringe, the selected diluent container, and the selected medication container accessible by the robotic arm as the robotic arm reaches through the opening.