Source: https://patents.google.com/patent/US8571708
Timestamp: 2018-06-18 09:05:29
Document Index: 75666608

Matched Legal Cases: ['Application No. 2', 'Application No. 11008863', 'Application No. 11008865', 'Application No. 11', 'Application No. 11', 'Application No. 11008863', 'Application No. 11008865', 'application No. 2008', 'Application No. 2', 'Application No. 201110220037']

US8571708B2 - Automated pharmacy admixture system (APAS) - Google Patents
US8571708B2
US8571708B2 US12566037 US56603709A US8571708B2 US 8571708 B2 US8571708 B2 US 8571708B2 US 12566037 US12566037 US 12566037 US 56603709 A US56603709 A US 56603709A US 8571708 B2 US8571708 B2 US 8571708B2
US12566037
US20100017031A1 (en )
This application is a continuation of and claims priority to U.S. patent application Ser. No. 11/316,795 by Ronald H. Rob et al., entitled “Automated Pharmacy Admixture System”, filed Dec. 22, 2005 and U.S. Provisional Patent Application Ser. No. 60/638,776 by Ronald H. Rob et al., entitled “Automated Pharmacy Admixture System”, filed Dec. 22, 2004, the contents of each are incorporated herein by reference.
FIG. 12 A-D shows the lock loading process of the rack into the carousel for the exemplary device of FIG. 1.
FIG. 15 A-C shows an exemplary air extraction process from an IV bag used in the exemplary device of FIG. 1
FIG. 17 A-C shows an exemplary diluent bag manipulator for use in the exemplary device of FIG. 1.
In conjunction with the APAS 100, a remote user station (RUS) 206 may provide inventory control, planning, and/or management and management functions. The RUS 206 may include a workstation 208, inventory racks 210, and inventory (e.g., drug containers) 212. The workstation 208 may be interfaced to the APAS 100, either directly or through a computer network (e.g., LAN, WAN, MAN, wLAN), which may be part of a hospital interface network in some implementations. The operator, for example, may use the workstation 208 to review, add to, prioritize, or amend drug orders and planned production for the APAS 100. The operator may also use the workstation 208 to plan and manage the compounding and/or dispensing of drug dosages by the APAS 100, and/or to report operations with regard to such processes. In another example, the workstation 208 may be used in APAS cell management to control the release of drug order queues to cells for the compounding process, or to monitor the APAS cell status during the compounding process. The workstation 208, and/or the APAS system 100, may include hardware and/or software for scanning identifying indicia, such a bar code, RFID tag, etc. . . . , to facilitate the identification of inventory, and/or the placement of the inventory on a rack.
In this example, an operator may use the RUS 206 to coordinate the loading of inventory racks 210. The inventory racks 210 may be loaded with inventory 212, which may include vials of various sizes 214, 216, syringes 218 and/or IV bags (not shown). In this embodiment, each of the racks 210 may store only one type or size of inventory items; however, different racks may be arranged to hold inventory items of various sizes. In some embodiments, one or more of the racks 210 may be configured to store multiple sizes and/or types of inventory items. In this embodiment, the racks 210 are arranged to store large vials 220, syringes 222, or small vials 224. Further embodiments of racks 210 for storing inventory may include racks for IV bags, and examples of such racks are described with reference to FIGS. 5 and 14, for example. Each inventory item may be manually placed within an appropriate support, which may include, for example, a retention clip, hook, shelf, bin, slot, or pocket on the rack 210.
In another illustrative example, a syringe may be used for both as an input containing a fluid (e.g., diluent or known drug compound) to be admixed in a compounding process, and as an output containing a prepared dose suitable for delivery to a patient. Such a syringe may be needed to fulfill a special or stat order programmed into the APAS 100 via the input/output capabilities of the monitor 202, for example. In this example, the operator performs in situ loading 226 by placing the syringes to be used for both reconstitution and dosing in pockets on a rack already located on the carousel 310. The operator enters the stat order into the APAS 100. The robotic arm 318 picks the selected syringe from a pocket in the rack in the carousel 310 and moves it to the decapper/deneedler station 320, where the needle cap is removed from the syringe/needle combination, thereby exposing the needle. The syringe is then transferred by the robotic arm 318 to a needle down syringe manipulator 334. At the station 334, diluent is drawn into the syringe from a diluent supply IV bag 336 previously placed there by the robotic arm 318. The diluent supply 336 may be contained in an IV bag which is hung on the needle down syringe manipulator 334 by a clip, as shown in FIGS. 6-7. After performing an air extraction process, the details of which are described with reference to FIGS. 15A-15C, the syringe punctures the membrane of the diluent port 338 (another example of which is shown in FIG. 7) in a needle down orientation. The syringe is actuated to remove, for example, a predetermined amount of the diluent from the IV bag. The needle down syringe manipulator 334 then moves a reconstitution vial 340, placed there previously by the robotic arm 318, under the syringe. The diluent in the syringe is transferred to the vial for reconstitution with the vial contents. The robotic arm 318 then moves the vial to the needle up syringe manipulator 322 where the appropriate amount of the reconstituted drug is drawn from the vial into an “output” syringe that was previously conveyed there by the robotic arm 318.
The control electronics may receive a unique electronic rack identification (e.g., hall sensor, encoder, bar code reader, pattern recognition, etc. . . . ) to identify the location of each rack on the carousel. This position information may be used to coordinate the rotation of the carousel to facilitate loading/unloading inventory, as well as supplying inventory to the robotic arm for processing.
In some embodiments, force feedback may be used in combination with position sensing (e.g., using potentiometers, encoders, etc. . . . ) to coordinate and control grasping of the gripper fingers with the robot arm movements so that the robot may grasp, retain, and release items in a coordinated fashion. Force feedback and gripper finger position sensing may be monitored to determine whether an item to be grasped is where it is expected to be, and whether it has the proper dimensions. For example, if force feedback indicates that that outer diameter of a syringe barrel is 10% larger than expected, then the APAS 100 may notify the operator of an error. As another example, if a syringe is too small for the pocket on the rack of the carousel, and is therefore tipped out an unexpected angle, then the force feedback and gripper finger position sensing may be able to detect such a condition and cause the APAS 100 to notify the operator.
FIG. 13 A-C shows an assembly sequence of loading a rack 1212 into a carousel 1200. FIG. 13A shows a first step 1300 in the assembly sequence where the rack 1212 is first engaged at the top in the carousel upper plate 1206. Next the rack 1212 can slide into the carousel 1200 by traveling over the rack retention rollers 1236 on the carousel lower plate 1238. FIG. 13B shows a second step 1302 in the assembly sequence where the rack 1212 is fully inserted into the carousel 1200. The rack 1212 has traveled over the rack retention rollers 1236 on the carousel lower plate 1238 engaging the rack alignment tongue 1234 within the lateral registration groove 1230, shown in FIG. 12. Now that the rack is fully inserted, FIG. 13C shows the last step 1304 in the assembly sequence where the rack 1212 is slid down and engages behind the rack retention rollers 1236 on the carousel lower plate 1238 and the rack alignment tongue 1202 on the carousel upper plate 1206 is engaged at the top. The rack 1212 can be lowered into the carousel 1200 so that the retaining face 1228 on the rack lower end plate 1224, as shown in FIG. 12, drops behind the rack retention rollers 1236 on the carousel lower plate 1238 and forms a captive retention in the carousel.
Each inventory rack style may contain multiple designs to accommodate the different sizes of each of the drug container types to be loaded on the racks. An inventory rack design may accommodate one size of a specific drug container or may accommodate a select number of sizes of a specific drug container. Examples of IV bag rack designs include, but are not limited to, a rack that can be loaded with up to four 1000 milliliter (ml) Baxter IV bags, a rack that can be loaded with up to eight 500 ml or 250 ml Baxter IV bags, in any combination, and a rack that can be loaded with up to twelve 100 ml and 50 ml Baxter IV bags, in any combination. Examples of vial rack designs include, but are not limited to, racks that can be loaded with up to eight 100 ml vials, up to eighteen 50 ml vials and up to twenty-two 20 ml vials. Another example rack design for vials can be loaded with fifty-eight 5 ml to 2 ml, in a combination of up to thirty 5 ml to 4 ml vials and up to twenty-eight 2 ml vials. Examples of syringe rack designs include, but are not limited to, racks that can be loaded with up to eight 140 cubic centimeters (cc) Monoject syringes, up to twelve 60 cc BD or Monoject syringes, up to fourteen 30 cc BD or 35 cc Monoject syringes, up to eighteen 20 cc BD or Monoject syringes, up to thirty-three 12 cc to 1 cc BD or Monoject syringes, or any of these in combination. Monoject syringes are commercially available from Tyco medical of Massachusetts. BD syringes are commercially available from Becton Dickson of New Jersey.
In some embodiments, the APAS 100 would have stored information (e.g., from visual inspection, weight measurement, historical information, user input, etc. . . . ) about the approximate fluid volume available in the IV bag. A controller in the APAS may determine when the available volume in the IV bag has been depleted to a level below which the IV bag may be discarded, or used for another purpose.
In some embodiments, the pressure in a chamber of the APAS may be different from ambient, such as up to at least about 10 inches of water (about 0.025 atmospheres or 25 millibars), or between about 0.1 and 1.0 inches of water (between about 2.5×10−4 and 2.5×10−3 atmospheres, or between about 0.25 and 2.5 millibars) above or below ambient atmospheric pressure. Negative pressure may reduce the likelihood that certain chemicals may be released outside the chamber, for example.
1. An automated pharmacy admixture system comprising:
an inventory chamber including a supply of medical containers including a first medical container and a second medical container, each medical container having at least one of a plurality of different fill port configurations;
a substantially aseptic chamber comprising at least one fluid transfer station configured to transfer fluids out of the first medical container and into the second medical container, wherein a first pressure level inside the substantially aseptic chamber is regulated to a differential pressure of up to twenty five millibars below an atmospheric pressure level proximate and exterior to the substantially aseptic chamber during a fluid transfer process;
a carrier that delivers the supply of medical containers to a location proximate or within the substantially aseptic chamber; and
an actuator to convey the medical containers to a first fluid transfer station within the substantially aseptic chamber.
2. The automated pharmacy admixture system of claim 1, further comprising:
a manipulator system to transport items within the substantially aseptic chamber; and
actuating the manipulator system to bring a fill port of the second medical container and a fluid transfer port into register with one another, and
actuating the manipulator system to move the second medical container and the fluid transfer port out of register after a fluid transfer operation.
3. The automated pharmacy admixture system of claim 2,
wherein the manipulator system is substantially disposed in a second substantially aseptic zone, and
the second substantially aseptic zone is regulated to a second pressure level substantially above or below ambient pressure.
4. The automated pharmacy admixture system of claim 3, wherein the second pressure level is higher than the first pressure level.
5. The automated pharmacy admixture system of claim 1, wherein the supply of medical containers comprises items selected from a group consisting of: syringes, IV bags, and vials.
6. The system of claim 1, further comprising a UV (ultraviolet) sanitization system to sanitize at least a portion of the fill port of the medical containers.
7. The system of claim 1, wherein the fluid transfer station is configured to inject a predetermined amount of air into the first medical container to facilitate withdrawal of fluid from the first medical container.
8. An automated pharmacy admixture system, comprising:
a carrier system to present a plurality of different types of medical containers to a location proximate or within a first substantially aseptic zone, wherein
the carrier system is substantially disposed in a second substantially aseptic zone at a second pressure level different than a first pressure level of the first substantially aseptic zone, and
the first aseptic zone is controlled to maintain the first pressure level between 0.25 and 25 millibars below an ambient atmospheric pressure level proximate and exterior to the first aseptic zone during a fluid transfer process;
a fluid transfer system disposed at least substantially within the first substantially aseptic zone, the fluid transfer system comprising a fluid transfer port to transfer fluids to or from the medical containers;
actuating the robotic manipulator system to transfer a first medical container to the fluid transfer system;
bringing a fill port of the first medical container and the fluid transfer port into register with one another; and
moving the fill port and the fluid transfer port out of register after a fluid transfer operation.
9. The automated pharmacy admixture system of claim 8, wherein the carrier system comprises a rotating carousel, the rotating carousel configured to hold different sizes or shapes of medical containers selected from a group comprising: syringes, IV bags, and vials.
10. The system of claim 8, wherein the operations further comprise actuating the robotic manipulator system to remove the first medical container from the fluid transfer system.
11. The system of claim 8, wherein the operations further comprise injecting a predetermined amount of air into the first medical container to facilitate withdrawal of fluid from the first medical container.
12. The system of claim 8, wherein the fluid transfer port comprises a first port of a needle on a first syringe and is coupled to exchange fluid with the first medical container while the needle is oriented substantially upward.
13. The system of claim 8, wherein the second pressure level is regulated below the ambient atmospheric pressure level.
14. An automated pharmacy admixture system, comprising:
a processing chamber that provides a substantially aseptic environment for a preparation of one or more pharmaceutical doses, wherein the system is configured to maintain a first pressure level inside the processing chamber that is up to 25 millibars below a first atmospheric pressure level proximate and exterior to the processing chamber during a fluid transfer process;
an inventory chamber exterior and adjacent to the processing chamber for storing within an interior of the inventory chamber a plurality of inventory items to be used in the preparation of one or more pharmaceutical doses, wherein
the plurality of inventory items comprises at least one container of diluent and at least one medication container including medication, and
the inventory chamber substantially encloses the plurality of inventory items in an environment substantially separate from an ambient environment outside of the inventory chamber, a second pressure level inside the inventory chamber being different than the first pressure level;
a multiple degree of freedom robotic arm disposed within the processing chamber and configured to reach into the inventory chamber, retrieve a first inventory item, present the first inventory item to a first process location in the processing chamber, release the first inventory item for processing at the first process location, and subsequently retrieve the first inventory item and convey the first inventory item to a second process location;
a fluid transfer station within the processing chamber, the fluid transfer station comprising a fluid transfer port to transfer fluids; and
a controller that is configured to cause steps to be performed to prepare a first pharmaceutical dose in an output container, the steps comprising:
(a) selecting at least a first diluent container and at least a first medication container to be used to prepare the first pharmaceutical dose,
(b) conveying the first diluent container to the fluid transfer station using the robotic arm, and
(c) conveying the first medication container to the fluid transfer station using the robotic arm.
15. The automated pharmacy admixture system of claim 14, further comprising a waste container situated to receive processed inventory items from the robotic arm.
16. The automated pharmacy admixture system of claim 15, wherein the waste container is disposed in a lower chamber disposed beneath the processing chamber.
17. The automated pharmacy admixture system of claim 14, wherein the first process location or the second process location comprises a weight scale for measuring a weight of the first inventory item.
18. The automated pharmacy admixture system of claim 14, further comprising an exterior access portal in a second side of the inventory chamber, wherein the exterior access portal is operable from a closed position to an open position to provide an operator access to the plurality of inventory items stored within the inventory chamber.
19. The automated pharmacy admixture system of claim 14, wherein the steps to be performed to prepare the first pharmaceutical dose in the output container further comprise storing information indicative of a remaining volume in the first diluent container.
20. The automated pharmacy admixture system of claim 8, wherein the second pressure level is positive in relation to the first pressure level.
21. The automated pharmacy admixture system of claim 1, wherein the first container is a syringe including a plunger, the system further comprising:
a sensor configured to detect a change in force or speed in moving the plunger; and
a controller configured to determine whether the syringe is withdrawing a gas or a liquid based on the change detected by the sensor.
22. The automated pharmacy admixture system of claim 1, wherein
the inventory chamber includes a plurality of holders configured to hold the supply of medical containers, each holder having a geometry to hold a medical container by the fill port of the medical container.
23. The automated pharmacy admixture system of claim 22, further comprising:
a robotic arm including two pairs of grippers, which are respectively configured to simultaneously grip the fill port of the medical container at positions above and below the holder to remove the fill port of the medical container from the holder or insert the fill port of the medical container into the holder.
24. The automated pharmacy admixture system of claim 1, further comprising:
a robotic arm including grippers to grip the plurality of different fill port configurations, the grippers having a plurality of different internal surface geometries, each of which corresponds to one of the different fill port configurations.
25. The automated pharmacy admixture system of claim 24, further comprising:
a controller configured to control the robotic arm and the grippers, based on a determination of a fill port configuration of a medical container to be moved, so as to align one of the internal surface geometries of the grippers, which corresponds to the determined fill port configuration, with a respective fill port of the medical container.
US12566037 2004-12-22 2009-09-24 Automated pharmacy admixture system (APAS) Active 2026-08-08 US8571708B2 (en)
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US12566037 US8571708B2 (en) 2004-12-22 2009-09-24 Automated pharmacy admixture system (APAS)
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ROB, RONALD H.;ELIUK, WALTER W.;MLODZINSKI, LANCE R.;REEL/FRAME:036495/0501
Free format text: ASSET PURCHASE AGREEMENT;ASSIGNOR:INTELLIGENT HOSPITAL SYSTEMS, INC.;REEL/FRAME:036551/0876
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