Automated use of a vision system to detect foreign matter in reconstituted drugs before transfer to a syringe

• US 7,163,035 B2
• Filed: 05/13/2004
• Issued: 01/16/2007
• Est. Priority Date: 05/13/2004
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Nasiri, Abdolhosein, Khan, Wahid
• Primary Examiner(s): Maust; Timothy L.
• Application Number:
  US10/846,959
• Publication Number:
  US 20050252572A1
• Time in Patent Office: 978 Days
• Field of Search: 141/2, 141/7, 141/9, 141 21- 27, 141/83, 141/94, 141100-105, 141/234, 141/247, 604/407
• US Class Current: 141/94
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

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: an automated device for delivering a prescribed unit dose of medication to the syringe by delivering the medication through the uncapped barrel. One exemplary automated device for delivering a prescribed unit dose of medication to the syringe is in the form of an automated device having a fluid delivery device that is movable in at least one direction. The fluid delivery device is adapted to perform the following operations: (1) receiving and discharging diluent from a diluent supply in a prescribed amount to reconstitute the medication in a drug vial; and (2) aspirating and later discharging reconstituted medication from the drug vial into the syringe. The system further includes a sensor for detecting any foreign matter (e.g., undissolved drug, pieces of septum, etc.) present in the reconstituted unit dose of drug prior to transfer of the reconstituted drug (unit dose) to the syringe.

Claims

1. 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 unit dose of medication to the syringe by injecting the medication through an uncapped barrel, wherein the automated device for delivering the unit dose of medication to the syringe comprises an automated device having a fluid delivery device that includes a main conduit, wherein the fluid delivery device is adapted to perform the following operations;

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

(2) aspirating the reconstituted medication into the main conduit and later discharging the reconstituted medication from the drug vial into the syringe; and

a first sensor to detect foreign matter present in the reconstituted medication prior to transfer of the reconstituted medication to the syringe, and whereupon, if foreign matter is detected, then a detection signal is generated and optionally the reconstituted medication is prevented from being delivered to the syringe, wherein the main conduit of the fluid delivery device contains the reconstituted medication and the sensor is disposed around the main conduit for detecting the foreign matter before transfer to the syringe.

2. The automated system of claim 1, wherein the fluid delivery device is fluidly connected to the 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.

3. The automated system of claim 2, 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.

4. The automated system of claim 3, 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 fluid delivery device.

5. The automated system of claim 4, wherein the first volume is at least 50% greater than the second volume.

6. The automated system of claim 4, 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.

7. The automated system of claim 6, 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.

8. The automated system of claim 6, 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.

9. The automated system of claim 6, 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.

10. The automated system of claim 1, wherein the first sensor is a photoelectric sensor that detects any reflection of an emitted beam which is indicative of foreign matter being present in the aspirated medication that is contained within a fluid conduit that forms a part of the fluid delivery device.

11. The automated system of claim 10, wherein the first sensor includes a light-emitting element for producing the light beam and a light-receiving element for receiving any light beam that reflects off of the foreign matter, the first sensor generating and sending a signal to a master controller if the first sensor detects the foreign matter, the master controller being in communication with components of the system.

12. The automated system of claim 11, wherein the first sensor is part of a vision system that is operatively connected to the master controller and is configured to be able to differentiate between a presence of air bubbles in the medication and unwanted foreign matter, wherein if air bubbles are present in the medication, the master controller still instructs the unit dose of medication to be delivered to the syringe.

13. The automated system of claim 11, wherein the first sensor is a diffusive-reflective sensor that is configured to detect particles as small as 50 micron, the light-emitting element and the light-receiving element being contained within a single housing that is positioned facing a main conduit.

14. The automated system of claim 13, wherein the first sensor is configured and has a sensitivity such that it is capable of detecting air bubbles as well as the foreign matter in the form of solid particles.

15. The automated system of claim 1, wherein the foreign matter is an amount of undissolved medication or solid particles contained in the medication.

16. The automated system of claim 1, wherein the medication is aspirated into the main conduit that is a part of the fluid delivery device and the first sensor is constructed to transmit light through the main conduit and includes a detector for dectecting the beam after it passes through the main conduit such that any foreign material that is present in the main conduit occludes the light causing the detector to send a signal to the master controller indicating the presence of the foreign matter.

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

an automated device for reconstituting and delivering a prescribed unit dose of reconstituted medication to the medication delivery device;

a first sensor to detect foreign matter present in the reconstituted medication prior to transfer of the reconstituted medication to the medication delivery device, and whereupon, if foreign matter is detected, then a detection signal is generated and optionally the reconstituted medication is prevented from being delivered to the medication delivery device; and

a second sensor that comprises a photoelectric sensor that lacks sensitivity to detect minute particles but is capable of detecting air bubbles and generates a signal when air bubbles are detected.

18. The automated system of claim 17, wherein the second sensor comprises a definite-reflective sensor that is placed adjacent the first sensor exterior to a main conduit that receives the reconstituted medication.

19. The automated system of claim 17, wherein the first sensor comprises a diffusive-reflective sensor that is capable of detecting both air bubbles and solid particles and the second sensor in combination with the first sensor forms a filter to filer out false positives that can result if the first sensor detects air bubbles as opposed to solid particles such that if a master controller in communication with both sensors and receives signals from both the first and second sensors then the master controller filters out the false positive and the aspirated unit dose of medication is delivered to the syringe.

20. A method for automated preparation of a medication comprising the steps of:

providing a medication preparation device for reconstituting and delivering a prescribed unit dose of reconstituted medication through a main fluid conduit to a medication delivery device,

mounting a first sensor to the medication preparation device such that the first sensor is movable with the medication preparation device, the first sensor being configured to detect foreign matter present in reconstituted medication contained within the main fluid conduit prior to transfer of the reconstituted medication to the medication delivery device;

focusing the first sensor on a meniscus region of the reconstituted medication;

detecting by means of the first sensor the presence of any foreign matter in the reconstituted medication located in the main fluid conduit, wherein the sensor is a reflective type sensor that detects light reflected by the foreign matter; and

delivering the reconstituted medication to the medication delivery device if the reconstituted medication is free of foreign matter and whereupon, if foreign matter is detected, a signal is delivered to the fluid delivery device and the reconstituted medication is optionally prevented from being delivered to the medication delivery device.

21. The method of claim 20, wherein the step of delivering the reconstituted medication to the medication delivery device comprises the step of delivering the reconstituted medication to an uncapped barrel of a syringe.

22. The method of claim 20, further including the steps of:

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

aspirating the reconstituted medication from the drug vial into the main fluid conduit.

23. The method of claim 21, wherein the step of detecting the presence of foreign matter comprises the steps of:

disposing an optical sensor proximate to but exterior to the main fluid conduit;

emitting a light beam toward the medication contained in the main fluid conduit;

detecting whether the light beam is reflected as a result of contacting foreign matter that is contained in the medication in the main fluid conduit; and

if the light beam is reflected, then the signal is delivered to the fluid delivery device and the reconstituted drug dosage is prevented from being delivered to the medication delivery device.

24. The method of claim 23, wherein the first sensor is a diffusive-reflective optical sensor and the step of detecting comprises the steps of:

emitting the light beam from a light-emitting beam that forms a part of a single sensor unit; and

detecting any reflected light beam with a light-receiving element that is part of the single sensor unit that is placed adjacent the main fluid conduit.

25. The method of claim 20, further comprising the step of:

disposing a second sensor adjacent the first sensor and proximate the main fluid conduit, wherein the second sensor has a sensitivity that permits detection of air bubbles and not solid particles,

emitting a light beam toward the medication contained in the main fluid conduit;

detecting whether the light beam is reflected and if so, generating an air bubble signal that is delivered to a master controller;

processing signals from one or both of the first and second sensors with the master controller such that if the first sensor detects reflection of its emitted light beam and the second sensor detects reflection of its emitted light beam, then the master controller determines the existence of a false positive and the reconstituted medication is delivered to the syringe.

26. The method of claim 20, wherein the fluid delivery device 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 medication preparation device through the main conduit which is primed, 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 medication preparation device;

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 a barrel thereof;

preventing fluid communication between the diluent source and the first syringe and allowing fluid communication between the second syringe and the medication preparation device;

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 medication preparation device 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 medication preparation device 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 fluid conduit into the syringe as a result of the volume of diluent being discharged from the syringe into the main conduit.

27. The method of claim 20, whereupon, if foreign matter is detected, then the system is instructed to deliver the reconstituted medication to the syringe and identify and optionally mark the syringe as requiring visual inspection.

28. The method of claim 27, further including the step of:

delivering the identified syringe to a separate station where visual inspection of the syringe can occur to determine whether the syringe is suitable for use.

29. A method for automated preparation of a unit dose of medication comprising the steps of:

providing an automated medication preparation device for reconstituting and delivering the unit dose of reconstituted medication through a main fluid conduit to a medication delivery device, wherein the medication preparation device is adapted to aspirate the reconstituted medication into the main fluid conduit after reconstitution thereof;

disposing a first sensor proximate the main fluid conduit to detect foreign matter present in the reconstituted medication contained in the main fluid conduit prior to transfer of the reconstituted medication to the medication delivery device;

aspirating the reconstituted medication into the main fluid conduit;

detecting by means of the first sensor the presence of any foreign matter in the reconstituted medication aspirated into the main fluid conduit;

differentiating between air bubbles and the foreign matter, wherein the first sensor only generates a signal instructing that the unit dose of medication be discarded if foreign matter is present in the medication as opposed to air bubbles; and

delivering the reconstituted medication to the medication delivery device if the reconstituted medication is free of foreign matter and whereupon, if foreign matter is detected, a signal is delivered to the fluid delivery device and the reconstituted medication is optionally prevented from being delivered to the syringe.

30. A method for automated preparation of a unit dose of medication comprising the steps of:

providing an automated medication preparation device for reconstituting and delivering the unit dose of reconstituted medication through a main conduit to a medication delivery device;

disposing a first sensor proximate the main fluid conduit to detect foreign matter present in the reconstituted medication contained in the main fluid conduit prior to transfer of the reconstituted medication to the medication delivery device;

aspirating the reconstituted medication into the main fluid conduit;

detecting by means of the first sensor the presence of any foreign matter in the reconstituted medication that is aspirated into the main fluid conduit; and

delivering the reconstituted medication to the medication delivery device if the reconstituted medication is free of foreign matter and whereupon, if foreign matter is detected, a signal is delivered to the fluid delivery device and the reconstituted medication is optionally prevented from being delivered to the syringe;

wherein the step of disposing the first sensor comprises the step of;

disposing the first sensor adjacent a meniscus of the medication in the main fluid conduit.

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

an automated device for delivering a prescribed dose unit of medication to the medication delivery device, wherein the automated device for delivering the unit dose to the medication delivery device comprises an automated device having a fluid delivery device that is in communication with a master controller; and

a sensor arrangement disposed proximate the main fluid conduit and including at least one sensor and is configured in combination with the master controller to be able to differentiate between a presence of air bubbles in the medication and unwanted foreign matter in the medication, the sensor arrangement being disposed adjacent a meniscus region of the medication in the main fluid conduit to detect the presence of any air bubbles and foreign matter in the meniscus region, wherein if air bubbles are present in the medication, the master controller instructs the unit dose of medication to be delivered to the medication delivery device, while if foreign matter is present in the medication, then the handling of the reconstituted medication is influenced.