AUTOMATED DRUG PREPARATION APPARATUS INCLUDING DRUG VIAL HANDLING, VENTING, CANNULA POSITIONING FUNCTIONALITY

• US 20080169043A1
• Filed: 10/20/2006
• Published: 07/17/2008
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: Forhealth Technologies Incorporated (Baxter International Inc.)
• Inventors: Valentine, Matt, Shafer, Jim, Bautista, Dexter, Wallace, Morris W., Osborne, Joel A., Hughes, Roy A., Bender, Jayson Lee, Tribble, Dennis, Khan, Abdul Wahid
• Granted Patent: US 7,900,658 B2
• Time in Patent Office: Days
• US Class Current: 141/1
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: B01F 31/201 Holders therefor
• 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: B01F 35/422 having a jaw-type or finger-type shape
• 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 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 of withdrawing a precise amount of drug from a drug vial in an automated manner comprising the steps of:

identifying the type of drug vial being used;

accessing a database to retrieve one or more stored vial characteristics that are associated with the identified drug vial;

positioning a vented cannula relative to the drug vial based on the stored vial characteristics such that in a first mode of operation, a vent port of the vented cannula is open and the drug vial is vented to atmosphere and in a second mode of operation, the vent port is closed; and

drawing the precise amount of drug from the drug vial.

2. The method of claim 1, wherein the stored vial characteristics include information about the dimensions of a septum of the drug vial through which the vented cannula is inserted to access an interior chamber of the drug vial and the step of positioning the vented cannula comprises the steps of:

retrieving a thickness of the septum from the stored septum dimensions; and

calculating a position of the vented cannula in the first mode of operation where both an open tip of the vented cannula and the vent port clear the septum and are located in the interior chamber and calculating a position of the vented needle in the second mode of operation where only the open tip end clears the septum and is located in the interior chamber.

3. The method of claim 1, wherein the stored vial characteristics include a draw angle that is a measure of the vented cannula relative to a planar ground surface reference at a time of drawing drug and further including the step of:

positioning the vented cannula at the stored draw angle for the identified drug vial.

4. The method of claim 1, wherein the stored vial characteristics include a characteristics relating to a material that forms the septum and the step of positioning the vented cannula comprises the steps of:

calculating a piercing speed of the cannula based on the material characteristic of the septum of the identified drug vial; and

driving the cannula at the piercing speed through the septum and into an interior of the vial.

5. The method of claim 4, wherein the piercing speed increases as a hardness of the material of the septum increases.

6. The method of claim 1, wherein the vented cannula is part of an automated drug preparation apparatus and the step of drawing the precise amount of drug comprises the step of:

aspirating the precise amount of drug from the drug vial.

7. The method of claim 1, wherein the vented cannula is part of a syringe and the step of drawing the precise amount of drug comprises the step of:

extending a plunger of the syringe so as to draw the precise amount of drug into the syringe.

8. The method of claim 1, wherein the step of drawing the precise amount of drug comprises the steps of:

first positioning the vented needle in the first mode of operation and drawing a first volume of drug; and

subsequently positioning the vented needle in the second mode of operation where only an open tip of the vented cannula clears the septum and the vent port is closed to draw a second volume of drug that is substantially less than the first volume and where a sum of the first and second volumes at least about equals the precise amount of drug.

9. The method of claim 2, wherein the drug vial is a multi-use drug vial that is used a number of different times and further including the step of:

piercing the septum of the multi-use drug vial at different locations during successive piercings of the septum by the vented cannula to prevent coring of the septum.

10. The method of claim 9, wherein the stored vial characteristics include stored septum piercing coordinates that define the different locations for the vented cannula to be inserted through on successive piercings of the septum by the vented cannula.

11. The method of claim 9, wherein a control unit of the vented cannula moves laterally to position the vented cannula at a next septum piercing coordinate based on the stored coordinates and past history of the multi-use drug vial which is to be pierced so that no two consecutive piercing actions for the same vial occur at the same location.

12. The method of claim 1, wherein the step of identifying the type of drug vial being used comprises the steps of:

initially entering and storing a drug order that includes drug identification and vial identification information;

placing an identifier on a surface of the drug vial, the identifier having an identification code that uniquely identifies the drug vial;

reading the identification code with a reader; and

comparing the read identification code with the stored vial identification information and if the two match, the vented cannula is instructed to pierce the septum of the drug vial and if the two do not match, then the vented cannula is prevented from piercing the septum of the drug vial.

13. An automated drug preparation and delivery system comprising:

a storage location containing a plurality of drug vials, each drug vial containing an identification element coupled thereto;

a first robotic device for retrieving one drug vial from the storage location and moving it to another location;

an automated fluid delivery device having a vented cannula for processing a prescribed amount of a first fluid in a controlled manner, the vented cannula having an open tip for delivering and receiving the first fluid and a vent port proximate to but offset from the open tip; and

a controller including an input component to permit a user to enter a drug order and having software including a database that contains stored drug identification information and vial identification information;

wherein, the controller identifies the type of drug vial being used by reading the identification element and then positions the vented cannula relative to the drug vial based on the stored vial identification information such that in a first mode of operation, the vent port of the vented cannula is open and the drug vial is vented to atmosphere and in a second mode of operation, the vent port is closed and the drug vial is not vented.

14. The system of claim 13, wherein the identification element comprises a barcode that is affixed to the drug vial.

15. The system of claim 13, wherein the stored vial identification information includes the dimensions of a septum of the drug vial through which the vented cannula is inserted to access an interior chamber of the drug vial and the controller retrieves a thickness of the septum from the stored septum dimensions and calculates a position of the vented cannula in the first mode of operation where both the open tip of the vented cannula and the vent port clear the septum and are located in the interior chamber and calculates a position of the vented needle in the second mode of operation where only the open tip end clears the septum and is located in the interior chamber.

16. The system of claim 13, wherein the stored vial identification information includes a draw angle that is a measure of the vented cannula relative to a planar ground surface reference and the controller positions the vented cannula at the stored draw angle for the identified drug vial.

17. The system of claim 13, wherein the automated fluid delivery device includes a pump mechanism that is operatively coupled to the vented cannula and includes an aspiration mode for aspirating a predetermined amount of first fluid from the drug vial and an injection mode for discharging a predetermined amount of first fluid from the vented cannula, and wherein the vented cannula is part of a syringe that includes a plunger and the system further includes an adjustable plunger extension mechanism that includes a movable component that intimately engages the plunger so that movement of the movable component is translated into extension of the plunger a first defined distance that causes a precise amount of the first fluid to be drawn into the syringe.

18. The system of claim 13, wherein the automated fluid delivery device is configured to first position the vented cannula in the first mode of operation resulting in a first volume of first fluid being drawn into the vented cannula;

and subsequently position the vented cannula in the second mode of operation where only an open tip of the vented cannula clears the septum and the vent port is closed to draw a second volume of the first fluid that is substantially less than the first volume and where a sum of the first and second volumes at least about equals the precise amount of first fluid.

19. The system of claim 13, wherein the drug vial is a multi-use drug vial that is used a number of different times and the stored vial identification information includes stored septum piercing coordinates mapped relative to an exposed top surface of the septum of the drug vial that define different locations for the vented cannula to be inserted through on successive piercings of the septum by the vented cannula.

20. The system of claim 19, wherein the controller positions the vented cannula at a next septum piercing coordinate based on the stored septum piercing coordinates and a stored past history of the multi-use drug vial which is to be pierced so that no two consecutive piercing actions for the same vial occur at the same location.

21. A method of withdrawing a drawing a prescribed dosage of medication from a drug vial comprising the steps of:

identifying the type of drug vial being used;

accessing a database to retrieve stored vial identification information that is associated with the identified drug vial, the vial identification information includes dimensions of a septum of the drug vial;

retrieving a thickness of the septum from the stored septum dimensions;

calculating, based on the thickness of the septum, a first position of a vented cannula in a first mode of operation where both an open tip of the vented cannula and the vent port clear the septum and are located in an interior chamber of the vial;

calculating, based on the thickness of the septum, a second position of the vented needle in the second mode of operation where only the open tip end clears the septum and is located in the interior chamber;

first positioning the vented needle in the first mode of operation and drawing a first volume of the medication; and

subsequently positioning the vented needle in the second mode of operation where only an open tip of the vented cannula clears the septum and the vent port is closed and drawing a second volume of medication that is substantially less than the first volume and where a sum of the first and second volumes is equal to a total volume of the prescribed dosage of medication.

22. The method of claim 21, wherein the first volume is at least 90% by volume of a total volume of the dosage of medication.

23. An automated drug preparation and delivery system for preparing a dosage of medication comprising:

a storage location containing a plurality of drug vials, each drug vial containing an identification element coupled thereto;

a first robotic device for retrieving one drug vial from the storage location and moving it to another location;

an automated fluid delivery device in selective fluid communication with a source of diluent and configured to prepare reconstituted medication in the drug vial;

a master controller including an input component to permit a user to enter a drug order including a final weight of the dosage of medication;

a load cell for weighing the drug vial; and

a motion control system operatively coupled to the first robotic device for controlling movement of the first robotic device in at least one direction;

wherein, the controller identifies the type of drug vial being used by reading the identification element and the drug vial held by the first robotic device is delivered to the load cell for weighing by means of the motion control system which operates the first robotic device at a first mode to deliver the drug vial to within a prescribed distance from a surface of the load cell and then at a second mode to deliver the drug vial into contact with the surface of the load cell and at which time contact is made between the vial and the surface, the first robotic device opens to release the vial and collects a predetermined number of weight measurements, wherein the speed of the robotic device is greater in the first mode than the second mode.

24. The system of claim 23, wherein the controller detects the moment the drug vial contacts the surface of the load cell by monitoring the detected weight measurements of the load cell and once an increase in measured weight exceeds a threshold value, the controller sends a signal to the first robotic device to release the vial.

25. The system of claim 23, wherein the controller calculates the weight of the dosage of medication by subtracting a weight of the empty vial from a weight of the vial filled with medication.

26. The system of claim 23, wherein the controller calculates the weight of the dosage of medication by subtracting the weight of the vial before and after filling the medication at various points in the process and thus defies individual doses of all drugs introduced into the vial in the case of when the dosage of medication contains multiple drugs.

32. The system of claim 26, wherein the motion control system is configured to differentiate from the cannula impacting materials having a first hardness and materials having a second hardness that is greater than the first hardness and the controller processes this information to either confirm a proper positioning of the cannula or take remedial action.

33. The system of claim 32, wherein materials having a first hardness comprise materials forming a septum of the vial and wherein materials having a second hardness comprise materials forming one of a vial body, vial cap and septum retention collar.

34. The system of claim 26, wherein the controller labels the cannula as being contaminated if the controller detects that the object that the cannula interacts with is other than a septum of the vial and upon being labeled as being contaminated, the controller instructs that remedial action be taken with respect to the cannula.

35. The system of claim 26, wherein the motion control system includes an optical encoder that is in communication with the controller for controllably moving the cannula with precision so as to permit the features of the cannula and the other object to be mapped.

36. The system of claim 35, wherein the interaction between the cannula and the other object is plotted by means of a one dimensional map with a position of the cannula as measured by encoder counts being measured on one axis and a position error as measured by encoder counts being measured on another axis.

27. An automated drug preparation and delivery system comprising:

a storage location containing a plurality of drug vials;

a first robotic device for retrieving one drug vial from the storage location and moving it to another location;

an automated fluid delivery device having a vented cannula for processing a prescribed amount of a first fluid in a controlled manner, the vented cannula having an open tip for delivering and receiving the first fluid and a vent port proximate to but offset from the open tip, the fluid delivery device having a motion control system that performs simultaneous localization and mapping (SLAM) of features associated with the cannula and another object so as to permit the device to detect a nature of an interaction between the cannula and the other object; and

a controller for moving the vented cannula based on information obtained from the SLAM operation.

28. The system of claim 27, wherein the motion control system is a system selected from the group consisting of a one dimensional control system, a two dimensional control system and a three dimensional control system.

29. The system of claim 27, wherein the motion control system is configured to detect when at least one cannula feature interacts with at least one of a vial feature and a syringe feature.

30. The system of claim 29, wherein when a cannula tip touches a septum of the vial, it defines this as a first reference point in the controller and the controller then controls a depth or distance of the cannula tip insertion through the septum inside the vial.

31. The system of claim 29, wherein the cannula feature is selected from the group consisting of a cannula hub, a cannula hub tip, a cannula body, and a cannula tip;

the vial feature is selected from the group consisting of a septum outer wall, a septum body, a vial body, a septum retention collar, a vial cap and free air; and

the syringe feature is selected from the group consisting of a syringe lure, a syringe body, a syringe plunger and a syringe cap.

37. The system of claim 27, further including a camera device and wherein the drug vial is placed on a pedestal and is analyzed by the camera device and the controller automatically calculates vial dimensional characteristics, including at least height, diameter, and neck position, for vial manipulation by the first robotic device.