AUTOMATED DRUG PREPARATION APPARATUS INCLUDING SYRINGE LOADING, PREPARATION AND FILLING

• US 20080169044A1
• Filed: 10/20/2006
• Published: 07/17/2008
• Est. Priority Date: 10/20/2006
• Status: Abandoned Application

• Current Assignee: FHT, Inc.
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Wallace, Morris W., Osborne, Joel A., Tribble, Dennis, Khan, Abdul Wahid, Lefebre, Edward J.
• Application Number:
  US11/551,608
• Publication Number:
  US 20080169044A1
• Time in Patent Office: Days
• US Class Current: 141/1
• 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: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

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

providing a sealed bag that contains a syringe with a plunger and a cap in a sterile environment;

breaking a seal of the bag and removing the syringe and placing the cap at a predetermined first location;

delivering a prescribed dosage of the drug in an automated manner to the syringe; and

retrieving the cap and placing the same cap back on the syringe after the prescribed dosage has been delivered to the syringe.

2. The method of claim 1, wherein delivery of the prescribed dosage of drug includes the step of:

reconstituting the drug in a drug vial and then aspirating the prescribed dosage of the drug in an automated manner.

3. The method of claim 1, wherein delivery of the prescribed dosage of drug includes the steps of:

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

4. The method of claim 1, wherein delivery of the prescribed dosage of drug includes the steps of:

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 the drug; and

extending a plunger of the syringe a predetermined distance to draw the prescribed dosage of drug into the syringe.

5. The method of claim 1, wherein placing the cap at the predetermined first location and retrieving the cap and placing the cap back on the syringe are performed by an automated robotic device and the cap is placed back on the syringe at a different location relative to a location where the tip cap is removed at placed at the predetermined first location.

6. The method of claim 5, wherein the cap is placed on a top deck of a transporter device on which the syringes are loaded for delivering the syringes from one location to another location.

7. The method of claim 1, wherein the cap is separate from the syringe in the sealed bag.

8. The method of claim 1, wherein the cap is coupled to a barrel of the syringe in the sealed bag.

9. The method of claim 1, further comprising:

an automated drug preparation system that includes a plurality of stations and a cam-indexed transporting mechanism that holds and delivers one syringe from one station to another station, with the cap being detached and removed from the syringe as it is advanced from at least one station to another station.

10. A computer display associated with an automated drug preparation system that includes a plurality of stations that process a drug delivery device and deliver a prescribed dosage amount of medication to the drug delivery device, comprising:

an image displayed on the computer display that shows a relationship between the plurality of stations and a transporter device that the stations are arranged about, the transporter device serving to transport each drug delivery device from one station to another station; and

each location where a drug delivery device is received and held about a periphery of the transporter device being identified with an identifier, wherein when the location is empty, the identifier that corresponds to this location has a first appearance, and when the drug delivery device is received and held at the location but is inactive, the corresponding identifier for this location has a second appearance and when the drug delivery device is located at an active station, the corresponding identifier has a third appearance, wherein each of the first, second and third appearances is visually different and distinct from one another;

wherein the movement of the transporter device and location and status of the drug delivery devices held thereon is displayed in-real-time on the screen.

11. The display of claim 10, wherein the drug delivery devices are syringes and each location contains a means for gripping and holding one syringe and the identifier comprises indicia that has an enclosed peripheral boundary, the indicia being empty in its first appearance and is colored a first color in its second appearance and is colored a second color different from the first color in its second appearance.

12. The display of claim 10, wherein two or more locations are active at the same time as a result of different drug delivery devices being operated on simultaneously at different stations.

13. The display of claim 10, wherein the image includes a region where a detected system error message is displayed, in an error mode, to inform an operator that a system error has occurred and whereupon, occurrence of the system error, the identifier that is associated with the station where the system error occurred or is closest to where the system error occurred, turns a third color different from the other colors and blinks to alert the operator where the system error is located.

14. The display of claim 10, wherein each identifier has a closed circle shape.

15. The display of claim 10, further including an identification tag that is a unique combination at least one of letters and numbers and is associated with one identifier, the identification tag being displayed on the computer proximate the associated identifier.

16. The display of claim 15, wherein the identification tag is an interactive screen element in that activation of the identification tag results in a detailed report being displayed, the report containing real-time information about the selected drug delivery device.

17. A process for loading syringes onto an automated drug preparation system that includes a plurality of stations comprising the steps of:

providing a plurality of bandoliered syringes that are banded together with a web;

feeding the bandoliered syringes in an automated manner onto a transporting device that has a number of distinct receiving sections for receiving the bandoliered syringes, with one syringe being received in one receiving section, for moving each syringe from one station to another station; and

monitoring and displaying in-real-time a location and a status of each syringe by means of a computer display that has a main monitoring screen that has images representing the plurality of stations and the transporting device, wherein a location of each receiving section is identified with an identifier, wherein when one receiving section is empty, the identifier that corresponds to this respective receiving section has a first appearance, and when the syringe is received and held at one receiving section but is at an inactive station, the corresponding identifier for this receiving section has a second appearance and when the syringe is located at an active station, the corresponding identifier has a third appearance, wherein each of the first, second and third appearances are visually different and distinct from one another.

18. The method of claim 17, wherein the identifier comprises indicia that has an enclosed peripheral boundary, the indicia being empty in its first appearance and is colored a first color in its second appearance and is colored a second color different from the first color in its second appearance.

19. The method of claim 17, further comprising the step of:

providing a region in the main monitoring screen where a detected system error message is displayed, in an error mode, to inform an operator that a system error has occurred and whereupon, occurrence of the system error, the identifier that is associated with the station where the system error occurred or is closest to where the system error occurred, turns a third color different from the other colors and blinks to alert the operator where the system error is located.

20. The method of claim 17, wherein each identifier has a closed circle shape.

21. The method of claim 17, wherein the step of feeding the bandoliered syringes in an automated manner onto a transporting device includes the steps of:

using a guide device to orientate the bandolier of syringes so that each syringe is in an upright position and is fed into one receiving section by means of a robotic device that places the syringe into the receiving section to permit retaining means of the transporter device to grip and retain the syringe.

22. 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, wherein at least one of the stations includes a peripheral device for performing at least one operation; 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;

a master controller that tracks and controls the movement of the transporting device and operation of equipment at one or more stations; and

an automated device for preparing the medication in a container and drawing and holding a first volume of the medication,

wherein the system is configured so that two or more separate drug delivery devices are acted upon at the same time at two or more different stations and wherein the first volume of medication contains a plurality of dosages of medication that is subsequently each delivered, successively, to different drug delivery devices that are advanced by the transporting device to form individual dosages of medication in each drug delivery device.

23. A method of preparing a dosage of medication with an automated drug preparation system and delivering it to a syringe including the steps of:

preloading a first syringe tip cap on a first tip holder that is part of a transport device that controllably transports each syringe from one station to another station and holds a plurality of syringes in spaced relationship, with each syringe being received and held at a location that has an associated tip holder, the fist tip holder and first syringe tip cap being located at a first location of the transport device;

loading at a first station a first syringe and holding the first syringe at the first location of the transport device, the first syringe being capped with a second tip cap and the first tip cap being held on the first tip holder at the first location;

removing the second tip cap from the first syringe using an automated robotic device and holding the second tip cap in grippers of the robotic device;

advancing the transport device so that the first syringe and the first tip cap on the first tip holder are moved from the first station to another location;

loading at the first station a second syringe and holding the second syringe at a second location of the transport device, the second syringe being capped with a third tip cap;

placing the held second tip cap on a second tip holder at the second location of the transport device;

removing the third tip cap from the second syringe using the automated robotic device and holding the third tip cap in grippers of the robotic device; and

sequentially delivering uncapped syringes to a medication transfer station where a prescribed dosage of medication is delivered sequentially to each syringe; and

placing the tip cap from the respective tip cap holder onto the syringe that is held at the same location on the transport device after the dosage of medication is delivered to the syringe.

24. 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, wherein one of the stations is a medication delivery station where a prescribed dosage of medication is delivered to the drug delivery device;

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; and

a dose verification device for measuring and verifying a volume of the prescribed dosage in the drug delivery device, the dose verification device including a laser light source that generates a light beam that is projected through the drug delivery device parallel to a longitudinal axis of the drug delivery device, the dose verification device having a camera on an opposite side of the drug delivery device relative to the laser light source, the camera being configured to observe different laser line segments that differ in their locations based on differences in index of refraction, one of the line segments being offset from the other line segments and being indicative of the volume of the prescribed dosage of medication, wherein the dose verification device processes coordinate information relative to the offset line segment to calculate the volume of the prescribed dosage of medication that is contained in the drug delivery device,

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

25. 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, wherein one of the stations is a medication delivery station where a prescribed dosage of medication is delivered to the drug delivery device;

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; and

a dose verification device for measuring and verifying a volume of the prescribed dosage in the drug delivery device, wherein if the dose verification device detects that a measured volume of the prescribed dosage of medication lies outside of an acceptable volume range, then the drug delivery device is identified as needing further inspection and is not automatically advanced to the next station;

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

26. The system of claim 25, wherein the dose verification device includes a laser light source that generates a light beam that is projected through the drug delivery device parallel to a longitudinal axis of the drug delivery device, the dose verification device having a camera on an opposite side of the drug delivery device relative to the laser light source, the camera being configured to observe different laser line segments that differ in their locations based on differences in index of refraction, one of the line segments being offset from the other line segments and being indicative of the volume of the prescribed dosage of medication, wherein the dose verification device processes coordinate information relative to the offset line segment to calculate the volume of the prescribed dosage of medication that is contained in the drug delivery device.

27. The system of claim 25, wherein the dose verification device comprises an infrared light source that is arranged so that a light beam generated thereby is directed towards the dosage of medication contained in the drug delivery device so that is passes through the dosage of medication and a lens that focuses the light beam to a detector that is configured to measure absorbance of the light by the dosage of medication in the drug delivery device and based on this absorbance, the volume of the dosage of medication is calculated.

28. The system of claim 25, wherein the dose verification device includes a capacitive sensor that includes first and second parallel plates on opposite sides of the drug delivery device and the device measures the capacitance between the first and second plates, which is proportional to a dielectric constant of the dosage of medication in the drug delivery device, the dose verification device including one of an amplifier and oscillator that generates an analog signal proportional to a variation in capacitance from which the volume of the dosage of medication is calculated.

29. The system of claim 25, wherein the dose verification device includes a camera that is positioned at a top of the drug delivery device for monitoring the filling of the drug delivery device by monitoring air bubbles that are present as the medication is delivered or a meniscus and once a number of air bubbles visible in the drug delivery device drops below a threshold value or a meniscus drops below a threshold value, the dose verification device registers that the medication has completely filled the drug delivery device and is in intimate contact with a top inner surface of the drug delivery device accounting for a reduction or elimination in visible air bubbles.

30. The system of claim 25, wherein the dose verification device includes a laser that generates a beam that is directed and is positioned at a target fill location relative to the drug delivery device such that once the beam is impinged by the medication, delivery of the medication is stopped and the volume of the dosage of medication is calculated.