Automated pharmacy admixture system

• US 8,386,070 B2
• Filed: 12/01/2009
• Issued: 02/26/2013
• Est. Priority Date: 03/18/2009
• 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., Reinhardt, Alex H., Deck, Dustin, Doherty, Thom
• Primary Examiner(s): MACKEY, PATRICK HEWEY
• Application Number:
  US12/628,884
• Publication Number:
  US 20100241270A1
• Time in Patent Office: 1,183 Days
• Field of Search: 700/213, 700/214, 700/228, 700/231, 700/90, 141/1, 141/114, 141/130, 221/191, 221/197, 221/198
• US Class Current: 700/214
• 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 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: B01F 33/85 Mixing plants with mixing receptacles or mixing tools that can be indexed into different working positions

Abstract

In a preferred implementation, an automated pharmacy admixture system (APAS) prepares intermediary IV bags as drug sources for creating highly diluted patient doses in syringes. During the compounding process the APAS may align needles with a vial seal opening so as to ensure repeated entry through the same vial puncture site via precise control of needle position, needle bevel orientation, and needle entry speed. These techniques can in certain implementations substantially improve bung pressure sealing and reduced particulate generation. The APAS optionally creates drug order queues for incoming drug orders wherein the orders can be sorted by priority, drug type or patient location. A phantom queue can be combined with the incoming drug order queues to include frequently used medicaments to minimize operator loading of the APAS.

Claims

1. A robotic automated pharmaceutical processing system comprising:

a processor-based interface configured to receive requests to prepare one or more pharmaceutical prescriptions; and

a controller coupled to the interface and configured to operate an automated prescription preparation device in response to the received requests, the automated prescription preparation device comprising;

an inventory chamber comprising a housing to store within the inventory chamber a plurality of inventory items to be used in the preparation of one or more pharmaceutical prescriptions;

an exterior access portal formed in a first side wall of the housing of the inventory chamber, wherein the exterior access portal is operable between a closed position and an open position to provide an operator access for loading and unloading inventory items in the inventory chamber;

a compounding chamber access portal in a second side of the inventory chamber;

a rotatable inventory carousel disposed in the inventory chamber to receive the plurality of inventory items, wherein the carousel is rotatable about a vertical axis and comprises a first plurality of locations each adapted to receive an IV bag, a second plurality of locations each adapted to receive a vial that contains a drug, and a third plurality of locations each adapted to receive a syringe configured with a plunger slidably disposed within a first end of a barrel and a needle coupled to a second opposite end of the barrel, and wherein the carousel is configured to bring a selected one of the locations in proximity to the compounding chamber access portal to present a selected inventory item being stored at the selected location to the compounding chamber access portal;

a compounding chamber adjacent to the inventory chamber and communicating with the inventory chamber through the compounding chamber access portal in the second side, the second side being disposed between the compounding chamber and the inventory chamber;

a multi-axis multi-linkage robot disposed within the compounding chamber and configured to grasp an inventory item being presented from the carousel in the inventory chamber to the compounding chamber access portal, convey the grasped inventory item to a first process location, release the inventory item for processing at the first process location, and subsequently convey the processed inventory item to a second process location in the compounding chamber;

a syringe manipulator station configured to hold a syringe with a needle directed in a generally upward orientation for drawing fluid through the needle from a vial into the held syringe;

a mixing station configured to impart a motion to the vial to mix the contents of the vial before the drawing of fluid from the vial;

an air handling system arranged to provide air flow through the compounding chamber;

a waste container area disposed in proximity to the compounding chamber to receive inventory items that have been processed in the compounding chamber; and

wherein the controller is adapted to cause articulation of the stations to create an intermediary IV bag with a reconstituted drug at a predetermined intermediate concentration, draw a dose of intermediate concentration from the intermediary IV bag, and further dilute the drawn dose to prepare a final dose at a predetermined final dilution.

2. The system of claim 1, further comprising an aperture that couples the compounding chamber to the waste container area, wherein the air handling system is arranged to cause at least a portion of the provided air flow to flow from an interior region of the compounding chamber through the aperture generally toward a waste container disposed in the waste container area.

3. The system of claim 1, wherein the air handling system is further arranged to produce a substantially uniform airflow from a ceiling of the compounding chamber toward a floor of the compounding chamber.

4. The system of claim 1, wherein the air handling system is further arranged to reduce air pressure inside the compounding chamber to a level substantially below an ambient air pressure proximate and exterior to the compounding chamber.

5. The system of claim 1, wherein the controller is adapted to articulate one or more stations to determine the weight of an empty IV bag.

6. The system of claim 5, wherein the controller is adapted to determine the amount of diluent to remove to accommodate addition of a predetermined amount of medicament to produce a needed concentration level.

7. The system of claim 1, further comprising a vial seal puncturing controller to position successive needles for entry into the same vial puncture site.

8. The system of claim 7, wherein the vial seal puncturing controller determines based at least in part on needle type the needle engagement speed and disengagement speed to minimize leakage and coring.

9. The system of claim 7, wherein the vial seal puncturing controller modifies needle to vial engagement angles to enhance bung puncture performance.

10. The system of claim 7, wherein the vial seal puncturing controller modifies canting of the vial relative to needle bevel to enhance bung puncture performance.

11. The system of claim 7, wherein a needle used to puncture the vial is a pencil point needle that includes side ports.

12. The system of claim 7, wherein the vial seal puncturing controller adjusts needle penetration to maximize the amount of diluent that can be withdrawn from the vial.

13. The system of claim 1, wherein the controller manages batch mode production queues at least in part by assigning priority of drug orders in the queues.

14. The system of claim 13, wherein the controller executes software polling via FTP and selectively interrupts batch mode processing.

15. The system of claim 13, wherein the controller determines the queue in which a drug order belongs by priority sorting, drug type sorting, or location sorting.

16. The system of claim 13, wherein the controller combines a phantom queue for future processing with an existing first group of drug orders for current processing, resulting in a third group of drug orders for processing and entry into the system.

17. The system of claim 1, wherein the controller detects and recovers from errors by recovery of unused drugs, diluent and containers and re-queuing drug orders.

18. The system of claim 1, wherein the controller acquires through training or programming an actual amount of accessible fluid in a specific container, wherein the actual amount of fluid in a container is more than or less than the nominal amount of fluid in the container.

19. The system of claim 1, comprising separate waste containers for specific types of medical waste comprising sharps, glass, plastic, and cytotoxic, wherein the system sorts the types of medical waste into the various waste containers and wherein each waste container has associated level sensors.

20. The system of claim 1, further comprising sensors on output chutes to detect whether a completed product is output from the system and wherein the controller interrupts processing at least in selected circumstances wherein the sensor does not indicate the output of a completed product.

21. The system of claim 1, wherein the controller minimizes cross contamination by controlling gripper finger force, orientation of gripped syringe to minimize affect of acceleration forces, or use of slurp function to draw fluid out of needle and into luer lock of syringe.

22. The system of claim 1, wherein the system is configured to enhance the release of labeled vials from gripper fingers by abrasion of moving grippers along axis of vial after partial release of gripper fingers.

23. The system of claim 1, further comprising a kit to convert the system to use a specific type of IV bag, wherein the kit includes a disposable clip for attachment to an IV bag.

24. The system of claim 1, further comprising a syringe printer platen adapted to register a label, the platen having a compliant area for improved adhesion of the label to a syringe.

25. The system of claim 1, wherein the controller includes a training interface to teach the robot interface relationships including locations of system stations or subsystems.

26. The system of claim 25, wherein the robot retains a teaching tool used during training operations, wherein the tool is optionally an optical transducer.