System and method for personalized injection treatment

• US 9,675,519 B2
• Filed: 01/27/2012
• Issued: 06/13/2017
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Aquavit Pharmaceuticals, Inc.
• Original Assignee: Aquavit Pharmaceuticals, Inc.
• Inventors: Chang, Sobin, Chun, Kwonsoo
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): Schmid, Andrew
• Application Number:
  US13/982,213
• Publication Number:
  US 20150034208A1
• Time in Patent Office: 1,964 Days
• Field of Search: 141 2, 141 21, 141 25, 141 26, 141 27, 141 39, 141230, 141231, 141323, 141329, 141330
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/2006 Piercing means
• CPC Class Codes: A61J 2200/70 Device provided with specific sensor or indicating means
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: B01F 2101/22 Mixing of ingredients for pharmaceutical or medical compositions
• CPC Class Codes: B01F 33/84 Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
• CPC Class Codes: B01F 33/841 with component receptacles fixed in a circular configuration on a horizontal table, e.g. the table being able to be indexed about a vertical axis
• CPC Class Codes: B01F 33/8442 using a computer for controlling information and converting it in a formula and a set of operation instructions, e.g. on the point of sale
• CPC Class Codes: B01F 33/848 using data, i.e. barcodes, 3D codes or similar type of tagging information, as instruction or identification codes for controlling the dispensing and mixing operations
• CPC Class Codes: B05B 15/55 using cleaning fluids
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

An automated system (100) for compounding pharmaceutical agents for injection treatment of a patient includes a housing (110) enclosing an interior space; an inventory structure (130) having a plurality of chambers (131) for individually holding one or more pharmaceutical agent—containing single use capsules (102), wherein each capsule has a volume capacity of from about 0.1 to about 10.0 mL liquid; means (140) for selecting capsules in accordance with predetermined pharmaceutical agents contained in said capsules; means (150) for moving the selected capsules to a processing area; means (165,166) for sequentially transferring a controlled quantity of the predetermined pharmaceutical agent with direct fluid communication from each selected capsule to a product container under positive or negative pressure; and means (151) for automatically discarding spent capsules from which the pharmaceutical agents have been removed after a single use.

Claims

1. A system for compounding pharmaceutical agents for injection treatment of a patient, which comprises:

a) a housing enclosing an interior space;

b) an inventory structure having a plurality of chambers for individually holding one or more pharmaceutical agent-containing single use capsules, wherein each capsule has a volume capacity of from about 0.1 to about 10.0 mL liquid;

c) means for selecting capsules in accordance with predetermined pharmaceutical agents contained in said capsules;

d) means for moving the selected capsules to a processing area;

e) means for sequentially transferring a controlled quantity of the predetermined pharmaceutical agent with direct fluid communication from each selected capsule to a product container under positive or negative pressure; and

f) means for automatically discarding spent capsules from which the pharmaceutical agents have been removed after a single use, wherein the system is configured to limit the capsules to a single use, and wherein the means for transferring the pharmaceutical agent comprises a means for mechanically compressing the capsule to provide a positive external pressure for moving the pharmaceutical agent from the capsule through a needle and into the product container.

2. The system of claim 1 further including means in the processing area for puncturing the selected capsules.

3. The system of claim 1 wherein the chambers of the inventory structure include a plurality of vertical racks for individually holding a plurality of channels members, each channel member holding a plurality of capsules in a vertical array, and each channel member having a bottom end.

4. The system of claim 3 wherein the means for selecting capsules includes a capsule separation mechanism at the bottom end of each channel, the capsule separation mechanisms being individually movable between a first position wherein the bottom end of the respective channel is closed to prevent passage of a capsule through the bottom end of the channel, and a second position wherein the bottom end of the channel is open to permit passage of a capsule therethrough.

5. The system of claim 1 wherein the means for moving the selected capsules to the processing area comprises a linear transport system.

6. The system of claim 2 wherein the product container is a product vial and the means for puncturing the capsule comprises a cap applied to the product vial, the cap possessing a needle and an air vent;

and, a mechanism for piercing the capsule with the needle.

7. The system of claim 1 wherein the means for discarding the spent capsules comprises a waste bin positioned in the interior of the housing into which the spent capsules are dropped.

8. The system of claim 1 wherein the inventory structure comprises a carousel, wherein the chambers are arranged around a circumferential periphery of the carousel, and the capsules are disposed within the chambers or in linear channel members removably insertable in the chambers.

9. The system of claim 8 wherein the chambers have a linear or zig-zag configuration.

10. The system of claim 8 wherein the capsules have an elongated cylindrical or prolate configuration and are horizontally or vertically oriented in respective chambers.

11. The system of claim 2 wherein the means for puncturing the capsules includes an extraction needle movable between a first position and a second position wherein the extraction needle pierces the end of a selected capsule sufficiently to draw pharmaceutical agent therefrom.

12. The system of claim 8 including an injection system positioned within the housing, the injection system including an injection nozzle which is movable between an initial upper position and a lower position for insertion into the product container.

13. The system of claim 12 wherein the injection nozzle is also laterally movable.

14. The, system of claim 12 further including a vacuum conduit associated with the injection nozzle.

15. The system of claim 12, further comprising a means for disposing waste produced by the cleaning of the injection system, wherein the means for disposing waste produced by the cleaning of the injection system comprises a drain leading to a waste solution container within the interior of the housing.

16. The system of claim 15, further comprising a means for cleaning the injection system, wherein the means for cleaning the injection system includes a capsule containing a sterile cleaning solution comprising ethanol and/or deionized water.

17. The system of claims 14 further including a vacuum pump.

18. The system of claim 1 wherein the product container is a hypodermic syringe having a needle attached to one end, a plunger, and a removable cap covering the needle, and wherein the means for transferring the pharmaceutical agent comprises mounting means for holding the hypodermic syringe, said mounting means being movable between a first position wherein the hypodermic syringe is spaced apart from the selected capsule to a second position wherein the needle penetrates the capsule, wherein the mounting means further includes means for grasping and pulling the plunger of the hypodermic syringe, and wherein the system further includes means for removing the cap.

19. The system of claim 1 further including a UV sterilizing lamp positioned in the interior of the housing.

20. The system of claim 1 wherein, the pharmaceutical agents include pharmaceutically effective amounts of one or more of vitamins, growth hormone, glucosamine, omega-3 fatty acids, onabotulinumtoxin A and/or insulin.

21. The system of claim 1 wherein the capsules and chambers are color coordinated.

22. The system of claim 1 further including a plurality of sensors positioned in the interior of the housing for monitoring the capsule inventory and operation of the system.

23. The system of claim 1 further including a label printer.

24. The system of claim 1 wherein the capsules are pressurized.

25. The system of claim 1 further including information input and output units.

26. The system of claim 1 wherein the pharmaceutical agents are injectables comprising one or more of vitamins, growth hormone, glucosamine, omega-3 fatty acids, onabotulinumtoxin A, and/or insulin, and the patient is a human or animal.

27. A method for compounding pharmaceutical agents for injection treatment of a patient, comprising:

a) storing a plurality of pharmaceutical agent-containing capsules in an inventory structure;

b) selecting one or more capsules according to the pharmaceutical agents contained therein;

c) puncturing the selected capsules with an extraction device;

d) withdrawing a quantity of pharmaceutical agents from the selected capsules under positive or negative pressure and transferring the withdrawn pharmaceutical agents to a product container;

e) discarding spent capsules from which the pharmaceutical agents have been withdrawn after a single use of the capsules, wherein the method requires that the capsules be limited to a single use, and wherein the transferring the withdrawn pharmaceutical agents to a product container comprises using a means for mechanically, compressing the capsule to provide a positive external pressure for moving the pharmaceutical agent from the capsule through a needle and into the product container.