System and pouch for medication pouch packaging

Abstract

To provide a system and method for providing large volume medication pouch packaging.SOLUTION: A pouch (200) and an automated packaging machine (100) for packaging medications in the pouch (200) are disclosed. The pouch (200) is provided for carrying a plurality of medications. The pouch (200) includes a plurality of separate compartments (708), each compartment carrying a sub-batch of medication. The pouch (200) also includes serrated edges (340) at both ends of the pouch (200) to separate the pouch (200) from adjacent pouches (200). The pouch (200) further includes a continuous identifier that spans the plurality of separate compartments (708) to give the appearance of one continuous pouch. The plurality of separate compartments (708) is separated by seals, but not by serrated edges. The continuous identifier includes boundaries (732) at both ends of the pouch (200).SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 843,025, filed May 3, 2019, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to pharmaceutical packaging systems, and more particularly to systems and methods for providing large volume pharmaceutical pouch packaging. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] US Patent Application Publication No. 2019 / 0112080 [Patent Document 2] US Patent Application Publication No. 2013 / 0318931 [Patent Document 3] US Patent Application Publication No. 2017 / 0015445 [Patent Document 4] U.S. Patent No. 10,187,593 Summary of the Invention

[0004] One embodiment provides a pouch for holding multiple medications. The pouch includes multiple separate compartments, each compartment having a sub-batch of medication. The pouch also includes serrations on both ends of the pouch to separate the pouch from adjacent pouches. The pouch further includes a continuous identifier that spans the multiple compartments to give the appearance of one continuous pouch. In some embodiments, the multiple separate compartments may be separated by a heat seal, but not by a serration. In some embodiments, the continuous identifier may include a border.

[0005] Another embodiment provides an automated packaging machine for packaging pharmaceutical products, the automated packaging machine including a cartridge for dispensing drugs, a packaging unit for receiving the drugs dispensed from the cartridge, and an electronic processor electrically coupled to the cartridge and the packaging unit. The electronic processor is configured to determine drugs in a batch of drugs and further determine whether the batch of drugs is to be split based on the drugs in the batch of drugs. The electronic processor is also configured to split the batch of drugs into a plurality of drug sub-batches in response to determining that the batch of drugs is to be split, and further to create a pouch including a plurality of compartments corresponding to the plurality of drug sub-batches using the packaging unit. The electronic processor is further configured to fill the plurality of compartments with the plurality of drug sub-batches using the packaging unit.

[0006] Another embodiment provides a method of packaging pharmaceutical products using an automated packaging machine, the method including: determining, using an electronic processor of the automated packaging machine, drugs in a batch of drugs; and determining, using the electronic processor, whether the batch of drugs is to be split based on the drugs in the batch of drugs. The method also includes, using the electronic processor, in response to determining that the batch of drugs is to be split, splitting the batch of drugs into a plurality of sub-batches of drugs, and using a packaging unit, creating a pouch including a plurality of compartments corresponding to the plurality of sub-batches of drugs. The method further includes filling the plurality of compartments with the plurality of sub-batches of drugs using the packaging unit. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 illustrates a front perspective view of an automatic packaging machine, according to some embodiments. [Diagram 2] 2 is a perspective view of a packaging unit of the automatic packaging machine of FIG. 1 according to some embodiments. [Diagram 3]3 illustrates a portion of the packaging unit of FIG. 2 including a base and a manifold, according to some embodiments. [Figure 4] 3 illustrates another portion of the packaging unit of FIG. 2 including a manifold, a container, and a valve mechanism, according to some embodiments. [Diagram 5] 3 illustrates another portion of the packaging unit of FIG. 2 including a manifold, a container, and a valve mechanism, according to some embodiments. [Figure 6] 3 illustrates another portion of the packaging unit of FIG. 2 including a manifold, a container, and a valve mechanism, according to some embodiments. [Figure 7] 1 illustrates a pouch with pharmaceutical products packaged inside, according to some embodiments. [Figure 8] 2 illustrates a portion of a packaging unit of the automated packaging machine of FIG. 1, the packaging unit including a valve mechanism in a first position, according to some embodiments. [Figure 9] 9 illustrates a portion of the packaging unit of FIG. 8 with the valve mechanism in a second position, according to some embodiments. [Figure 10] 3 illustrates a series of pouches formed using the packaging unit of FIG. 2, according to some embodiments. [Figure 11] 2 is a simplified block diagram of a control system for the automatic packaging machine of FIG. 1 according to some embodiments. [Figure 12] 3 is a front view of the packaging unit of FIG. 2 according to some embodiments. [Figure 13] 2 is a flow diagram of a method of packaging pharmaceutical products using the automated packaging machine of FIG. 1, according to some embodiments. [Figure 14A] FIG. 2 is a front view of a batch of drugs packaged using the automated packaging machine of FIG. 1, according to some embodiments. [Figure 14B] FIG. 2 is a rear view of a batch of drugs packaged using the automated packaging machine of FIG. 1, according to some embodiments. [Figure 15A] FIG. 2 is a front view of a sub-batch of a drug packaged using the automated packaging machine of FIG. 1, according to some embodiments. [Figure 15B] FIG. 2 is a rear view of a sub-batch of a drug packaged using the automated packaging machine of FIG. 1, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Before describing any embodiments of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways.

[0009] FIG. 1 illustrates an example automated packaging machine 100 including a universal supply cartridge 105 and a packaging unit 110. The universal supply cartridge 105 receives medication from a bulk canister and individually dispenses pills to the packaging unit 110. Each universal supply cartridge 105 can dispense up to 20 separate pills simultaneously. In the arrangement illustrated in FIG. 1 including the universal supply cartridge 105, the automated packaging machine 100 can be used to dispense and package 20 different pills simultaneously. An example universal supply cartridge is described in U.S. Patent Application Publication No. 2006 / 0139994, the entire contents of which are incorporated herein by reference.

[0010] A packaging unit 110 receives the individual pills and packages them into pouch packages that are provided to the consumer. In the example illustrated in Figure 1, the packaging unit is a strip packaging machine 110. Exemplary strip packaging machines are described in U.S. Patent Nos. 5,399,943 and 5,433,633, the contents of which are incorporated herein by reference in their entirety. Figure 1 illustrates merely an exemplary embodiment of an automated packaging machine 100. The automated packaging machine 100 may include more or fewer components than those illustrated in Figure 1 and may perform functions other than those explicitly described herein.

[0011] 2-6 illustrate one embodiment of a packaging unit 110 for use with the automated packaging system 100. In the illustrated example, the packaging unit 110 includes a base 114, a manifold 118, a container 122, two feedstock rolls 126, 130, and a take-up roll 134.

[0012] 2 and 3, the manifold 118 includes a plurality of separate tracks 138 corresponding to each of the cartridges of the universal supply cartridge 105 mounted to the base 114. The illustrated tracks 138 are independent channels that together form the manifold 118. The tracks 138 separate the medications from one another as they slide down the manifold 118 to the containers 122.

[0013] As shown in FIG. 3, cameras 142 are mounted on the base 114 adjacent to the outlets therein. Each camera 142 is associated with one of the cartridges of the universal supply cartridge 105 supported on the base 114. The cameras 142 are operable to determine whether the proper number and / or type of medications have been dispensed from the universal supply cartridge 105. The cameras 142 capture images of the medications exiting the base 114 and compare characteristics of the medications (e.g., color, outline, size, shape, markings, etc.) to stored images of the medications. In some embodiments, recognition software may be utilized to automatically compare the images captured by the cameras 142 to the stored images. In other embodiments, the captured images are sent to a remote pharmacist or technician who analyzes the images and confirms that the correct number and type of medications have been dispensed. In further embodiments, the cameras 142 may be infrared sensors that do not reveal a particular type of medication but simply detect whether an object (e.g., pills, etc.) falls through the base 114.

[0014] As shown in FIGS. 4-6, the container 122 receives pharmaceutical products from each of the tracks 138 in the manifold 118. In the illustrated embodiment, the container 122 includes a shutter or valve mechanism 146 that momentarily stops the pharmaceutical products before they are collected into pouches by the feedstock rolls 126, 130. The illustrated shutter mechanism 146 includes a plunger or push rod 150 that is movable between a first or lowered position (FIG. 5) and a second or raised position (FIG. 6). When in the lowered position, the plunger 150 prevents the pharmaceutical products from traveling out of the manifold 118. When in the raised position, the plunger 150 is moved out of the way to allow the pharmaceutical products to pass toward the packaging equipment (e.g., the feedstock rolls 126, 130). In some embodiments, the shutter mechanism 146 may include a solenoid or other suitable actuator to raise and lower the plunger 150.

[0015] In operation, the plunger 150 is initially in a lowered position (FIG. 5) to temporarily suspend the medication. The plunger 150 remains in this position until all of the requested medication is collected in the container 122. If an excess or incorrect medication (as may be determined by the camera 142) is dispensed from the universal supply cartridge 105, an air jet, deflector, or trap door may be utilized to remove the medication from the container 122 or from the manifold 118 before it reaches the container 122. In some embodiments, detecting whether an excess or incorrect medication is present may include inspecting the medication as it is in flight (e.g., falling from the base 114 into the manifold 118) as it is released from the universal supply cartridge 105. The camera 142 mounted on the base 114 may be used to identify each dispensed medication, for example, by reading markings on the pill. The camera 142 may be a high-speed camera and may include a prism and / or mirror to capture an overall image of the dispensed medication. A control system can then process the images captured by high speed camera 142 to determine whether the correct or intact medication has been dispensed from universal supply cartridge 105. Once the proper medication is within container 122, plunger 150 is actuated to the raised position (FIG. 6) so that the medication can be packaged into a pouch. Plunger 150 is then re-actuated to the lowered position to help push the medication into the pouch and await the next batch of medication.

[0016] FIG. 7 illustrates a pouch 200 having different pharmaceutical products 204 therein. The illustrated pouch 200 is one example of a pouch that may be formed using the packaging equipment of the packaging unit 110 described above. The pouch 200 is a clear plastic (e.g., cellophane) bag having three closed edges 208 and one open edge 212. A heat seal 216 extends across the pouch 200 adjacent the open edge 212 to seal the pouch 200. In some embodiments, all four edges 208, 212 of the pouch 200 may be closed via heat seals. Additionally or alternatively, the pouch 200 may be constructed of opaque and / or non-plastic materials. For example, one or both sides of the material may be opaque or colored (e.g., amber). As described above, the identifying indicia 220 (e.g., patient name, bar code, type of medication, etc.) is printed on the pouch 200 using, for example, a thermal printer, an inkjet printer, or a thermal transfer ribbon, etc. In other embodiments, the identifying indicia 220 may be printed on a label that is bonded to the pouch 200 using an adhesive. In further embodiments, the pouch 200 may include a header area and / or a footer area that is drug-free, but that provides space for printing or applying the indicia 220. In some embodiments, the packaging unit 110 may dispense empty (i.e., unfilled) pouches that contain specific information for the patient. This information may include, for example, instructions on how or when to take the medication, or reminders to obtain a new batch of medication, etc.

[0017] 8 and 9 illustrate a portion of another packaging unit 300 for use with the automated packaging system 100. The packaging unit 300 is similar to the above-described packaging unit 110. For descriptions of features and elements of the packaging unit 300 not specifically discussed below, reference is made herein to the description of the packaging unit 110 above.

[0018] In the illustrated embodiment, the packaging unit 300 includes a container 304 for controlling the pharmaceuticals (e.g., pills P) as they are packaged into pouches (e.g., pouch 200 shown in FIG. 7). The container 304 receives the pharmaceuticals from one or more tracks (e.g., track 138 of manifold 188 shown in FIG. 2) and directs the pharmaceuticals to the packaging equipment. As previously described, the packaging equipment may include two feedstock rolls and a take-up roll (e.g., rolls 126, 130, 134 shown in FIG. 2) to form the pouches. In other embodiments, the packaging equipment may include a single feedstock roll. The container 304 is located upstream of the packaging equipment to receive the pharmaceuticals from the tracks before the pharmaceuticals reach the packaging equipment.

[0019] The illustrated container 304 includes a collection area 308 and a valve mechanism 312. The collection area 308 is in communication with the track to receive the pharmaceutical product. The valve mechanism 312 blocks the pharmaceutical product before it reaches the packaging equipment. In the illustrated embodiment, the valve mechanism 312 includes a plunger or injector 316. The plunger 316 is movable relative to the track and collection area 308 between a first or lowered position (FIG. 8) and a second or raised position (FIG. 9). When in the lowered position, the plunger 316 blocks the pharmaceutical product from moving out of the collection area 308 toward the packaging equipment. When in the raised position, the plunger 316 is displaced to allow the pharmaceutical product to pass toward the packaging equipment. In the illustrated embodiment, the plunger 316 slides linearly between the lowered and raised positions. In some embodiments, the valve mechanism 312 may include a solenoid or other suitable actuator to raise and lower the plunger 316.

[0020] The illustrated container 304 also includes a flapper 320. The flapper 320 is located downstream of the collection area 308. The flapper 320 helps to manage the material 324 being discharged by the feedstock roll of the packaging machine to form the pouch. In particular, the flapper 320 extends in a path 328 between the collection area 308 and the packaging machine and engages the material 324 to inhibit the material 324 from tearing or binding. Additionally, the flapper 320 helps to hold the edges of the material 324 close together for seal formation. In the illustrated embodiment, the flapper 320 is pivotable relative to the path 328 about a pivot shaft 331. In other embodiments, the flapper 320 may move linearly relative to the path 328. In some embodiments, the flapper 320 may be biased in the path 328 by, for example, a spring.

[0021] In some embodiments, the flapper 320 can also selectively block the path 328 between the collection area 308 and the packaging equipment. When the plunger 316 is in the raised position (FIG. 9), the illustrated flapper 320 extends into the path 328 between the container 304 and the packaging equipment. In this position, the medication is held over the pouch before the medication is filled into the pouch. When the plunger 316 is in the lowered position (FIG. 8), the flapper 320 is removed from the path 328, allowing the plunger 316 to extend through the path 328. If the medication was held on the flapper 320 before the plunger 316 moved to the lowered position, the medication is also forced by the plunger 316 into the pouch formed by the packaging equipment. When the plunger 316 is returned to the raised position, the leading edge of the flapper 320 pushes the two halves of the pouch (i.e., the two strips of material 324) flat against each other.

[0022] In other embodiments, the flapper 320 may include a curve-out or indentation along its leading edge. The carve-out may generally match the shape and contour of the plunger 316. The carve-out provides an opening for the medication to move into the pouch without being blocked by the flapper 320. In such embodiments, the flapper 320 does not pinch the two sides of the pouch together along the entire edge, but only brings the edges of the two sides of the pouch closer together so that the top edge of the pouch can be closed.

[0023] In some embodiments, the plunger 316 is held between the materials 324 as the pouch is formed. More specifically, the pouch is formed by sealing (e.g., heat sealing) two strips of material 324 along three edges (e.g., bottom edge and two side edges). This seal forming process can be done in a single step using a U-shaped seal forming mechanism 330. The plunger 316 is placed between the strips of material 324 before the two strips of material 324 are sealed together. The seal forming mechanism 330 then creates a seal around the perimeter of the plunger 316. By creating a seal around the plunger 316, the two strips of material 324 are connected together but are not flat against each other. When the plunger 316 moves to the raised position (FIG. 9), the plunger 316 is removed from between the two strips of material 324 and the pouch remains open at the top. As described further below, the plunger 316 can be returned to a lowered position (FIG. 8) to help push the pharmaceutical product into the pouch. The two strips of material 324 can then be advanced so that the plunger 316 is between the upstream portions of the material 324. When the next pouch is ready to be formed, the U-shaped seal forming mechanism 330 can again seal the two strips of material 324 along three edges. The bottom seal of this pouch becomes the top seal of the previous pouch. A cutting mechanism can then, generally at the same time and stroke, create a serrated edge line through the bottom / top seal between the pouches to facilitate subsequent separation of the pouches. Alternatively, the cutting mechanism can cut the pouches apart at the seal when they are completed.

[0024] Figure 10 illustrates a portion of a series or strip of pouches 332 produced using packaging unit 300. The pouches 332 are sealed along all four edges with heat seals 336. To facilitate separation of the pouches 332, the heat seals 336 between the pouches 332 are formed with serrated edges 340. As shown in Figure 10, the pouches can be of different lengths, for example to accommodate different amounts of pharmaceutical products.

[0025] 8 and 9, in operation, the valve mechanism 312 physically pushes the medicine into the pouch to fill it, rather than relying on gravity to drop the medicine into the pouch. In particular, the plunger 316 of the valve mechanism 312 is initially in a lowered position (FIG. 8) as the container 304 receives the medicine from the track. While in the lowered position, the plunger 316 blocks the medicine from traveling to the packaging equipment, so that all of the medicine is initially collected in the collection area 308. Blocking the medicine with the valve mechanism 312 allows the medicines to settle together toward the bottom of the collection area 308 while the previous pouch is still sealed. The valve mechanism 312 inhibits the medicine from entering the wrong pouch. The valve mechanism 312 thereby increases the accuracy and speed of the packaging unit 300 and prevents errors. The valve mechanism 312 also inhibits the medicine from being crushed or damaged in the seal forming area of ​​the pouch by the seal forming mechanism 330. Additionally, the pouch is advanced at approximately the same speed as the valve mechanism 312 to inhibit the valve mechanism from damaging the medication or the pouch.

[0026] During this time, each feedstock roll of the packaging equipment releases material 324 to form a pouch. The material 324 from each feedstock roll forms one half of a pouch. The two halves are secured together along three sides or edges (e.g., the bottom and two sides) to close the sides and form the pouch. In the illustrated embodiment, the sides of the pouch are closed, for example, by heat sealing. Because the pouches are made on demand from the feedstock rolls, the length of the pouch can be variable (e.g., longer or shorter) depending on the amount of pharmaceutical product to be packaged, as shown in FIG. 10. For example, pouches having lengths of about 1 inch to about 3 1 / 4 inches are made, although pouches of other lengths are possible. The length of the pouch may be automatically determined by the packaging equipment based on the amount of pharmaceutical product expected to be filled into the pouch and the area required to print labeling and other information on the pouch. The amount of material needed to form a particular pouch may be identified on the material 324 by an index mark (e.g., a black line) painted on the material 324. When the packaging equipment sees this mark, the feedstock roll stops discharging the material 324. In embodiments where the packaging equipment includes only a single feedstock roll, the material 324 from the single roll may be folded along one side or edge to close that edge. In either embodiment, the material 324 may be pre-printed with pharmaceutical and patient-related indicia. After the pouch is initially formed, one of the heat seal elements detaches from the material 324. This action causes the pouch to open along its top, unclosed edge.

[0027] The illustrated plunger 316 also contributes to forming and shaping the pouch. When the plunger 316 is in the lowered position, the plunger 316 is located between two strips of material 324 that form the pouch. The material 324 can be closed (e.g., heat sealed) along three edges (e.g., bottom and two sides) to form the initial shape of the pouch. In the illustrated embodiment, the plunger 316 includes a substantially curved outer surface 344 on one side and a substantially flat outer surface 348 on the opposite side. The curved outer surface 344 forms one of the strips of material 324 in an arch relative to the other strip of material 324. This arrangement does not allow the arched strip of material 324 to lie flat against the other strip of material 324, making it easier for the pharmaceutical product to fill the pouch. Additionally, when the plunger 316 is removed from the pouch, a hole or gap is left between the top edges of the material 324, allowing the medication to move more easily into the pouch.

[0028] In some embodiments, once a pouch is formed around the plunger 316, the plunger 316 moves to a raised position (FIG. 9). The medication is then released from each cartridge of the universal supply cartridge 105. The medication falls by gravity through the manifold 118 into the pouch. The plunger 316 moves to a second position at the top of the pouch where an opening is formed that helps force the medication into the pouch. The plunger 316 then moves to a lowered position (FIG. 8) and the material 324 is advanced by the packaging equipment at approximately the same speed as the plunger 316 moves. When the plunger 316 is in the lowered position (FIG. 8), the top of the pouch is sealed with the side of the new pouch as described below.

[0029] In other embodiments, once all of the required medication has been collected in the collection area 308 and the pouch has been formed, the plunger 316 moves to the raised position (FIG. 9). The medication then falls from the collection area 308 towards the flapper 320, which in some embodiments blocks the path 328 to the packaging machine. The plunger 316 then moves back to the lowered position (FIG. 8) and helps to push the medication into the pouch. The material 324 is advanced by the packaging machine at approximately the same speed as the plunger 316 moves, so the plunger 316 does not crush or damage the medication, especially when the pouch is filled with many medications (e.g., 15-20 pills, or more). Instead, the plunger 316 pushes the medication to move it over and away from the seal forming mechanism 330 so that the seal forming mechanism 330 can create a top seal in the pouch. In some embodiments, the plunger 316 may also actuate a cam-type mechanism that moves the flapper 320 slightly ahead of the movement of the plunger 316. By using the plunger 316 to help push the medication into the pouch, more medications can be more reliably loaded into the pouch. For example, in some embodiments, the plunger 316 may be used to move 10-40 medications into a single pouch. Loading such a quantity of medications into a pouch may not be achievable by relying solely on gravity. In addition, such an arrangement allows more medications to be loaded into a single pouch than conventional devices, which reduces the chance of confusing a patient by providing all of the medications in a single pouch (rather than multiple pouches each with a few pills).

[0030] As the pharmaceutical agent is loaded into the pouch by the plunger 316, it advances the material 324 to begin forming the next pouch around the plunger 316. The flapper 320 is pivoted toward the plunger 316 to help hold the edges of the material 324 together. Once the material 324 has been sufficiently advanced by the feedstock rolls, a fourth side or edge (e.g., top) of the pouch is closed by a seal forming mechanism 330. As with the other sides, the fourth side of the pouch may be closed, for example, by heat sealing. As mentioned above, the seal that forms the fourth (or top) side of the pouch may also form the seal for the bottom of the next pouch. This process continues to create a series of separate pouches, as shown in FIG. 10.

[0031] The seal forming mechanism 330 creates a top seal along the seal forming region of the pouch (e.g., along the serrated edge 340, 612, 712 or the region along the heat seal 714 without a serrated edge, etc.). If a drug is present in the seal forming region 334 of the pouch, the seal forming mechanism 330 may crush or destroy the drug, rendering it useless for distribution. To prevent this damage, a sensor 338 (e.g., a camera, etc.) may be provided by the seal forming mechanism 330 (see FIG. 12) to detect drug that may be obstructing the seal forming region 334. The packaging unit 300 may stop sealing the pouch if drug is detected by the sensor 338. In some embodiments, a vibration mechanism may be provided in the seal forming mechanism 330 to vibrate the pouch so that the drug settles from the seal forming region 334 into the pouch. In some embodiments, sensors (e.g., cameras, etc.) may also be provided along the track 138 to detect if medication is stuck in the track 138 and cannot make it to the pouch. If the sensors in the track 138 detect medication stuck in the track, the pouch can be prevented from being sealed. In particular, the sensors in the track 138 detect if the path to the pouch is clear before the pouch is sealed.

[0032] The containers 304 of the packaging unit 300 facilitate filling the pouches with pharmaceutical agents more accurately, faster, and in greater volumes than packaging units that rely on gravity feed. As such, the pouches can be filled more reliably.

[0033] 1 and 12, in some embodiments, the packaging unit 110, 300 may include a printer 352 to print the patient name, date, the quantity and type of medication therein, a bar code, and / or other indicia on the pouch as it is formed. The printer 352 may be, for example, a thermal printer. In other embodiments, the printer 352 may include an ink ribbon or inkjet. Additionally, the packaging unit 110, 300 may include a bar code scanner or vision system 356 to monitor and check the pouch as it is spooled onto the take-up roll 134 or dispensed.

[0034] FIG. 11 illustrates one embodiment of a control system 400 for the automated packaging machine 100. The control system 400 controls the operation of the feedstock rolls 126, 130 to discharge and form pharmaceutical pouches, controls the printer 352 to print indicia on the material 324, and controls other components of the automated packaging machine 100. In the illustrated example, the control system 400 includes a processor 410, a memory 420, a transceiver 430, and an input / output interface 440. The processor 410, the memory 420, the transceiver 430, and the input / output interface 440 communicate via one or more control and / or data buses (e.g., a communication bus 450). FIG. 11 illustrates just one illustrative embodiment of the control system 400. The control system 400 may include more or fewer components and may perform functions other than those explicitly described herein.

[0035] In some embodiments, the processor 410 is implemented as a microprocessor with a separate memory, such as the memory 420. In other embodiments, the processor 410 may be implemented as a microcontroller (with the memory 420 on the same chip). In other embodiments, the processor 410 may be implemented using multiple processors. Additionally, the processor 410 may be implemented in part or in whole, for example, as a field programmable gate array (FPGA), application specific integrated circuit (ASIC), etc., and the memory 420 may not be required or modified accordingly. In the illustrated example, the memory 420 includes a non-transitory computer readable memory that stores instructions received and executed by the processor 410 to perform the functions of the control system 400 described herein. The memory 420 may include, for example, a program storage area and a data storage area. The program storage area and the data storage area may include a combination of different types of memory, such as read-only memory and random access memory.

[0036] The transceiver 430 enables wireless communication from the control system 400 to a remote electronic device, such as, for example, a remote pharmacist's server, a smart phone, or a tablet computer. In other embodiments, rather than the transceiver 430, the control system 400 may include separate transmitting and receiving components, such as, for example, a transmitter and receiver. In still other embodiments, the control system 400 may not include the transceiver 430 and may communicate with the remote device via a network interface and a wired connection to a communications network, such as the Internet.

[0037] As mentioned above, the control system 400 may include an input / output interface 440 (or, more generally, what is referred to as a user interface). The input / output interface 440 may include one or more input mechanisms (e.g., a touch screen, a keypad, buttons, knobs, etc.), one or more output mechanisms (e.g., a display, a printer, speakers, etc.), or a combination thereof. The input / output interface 440 receives input from input devices activated by a user and provides output to output devices with which the user interacts. In some embodiments, as an alternative or in addition to managing input and output via the input / output interface 440, the control system 400 may receive user input, provide user output, or both, by communicating with an external device, such as a console computer, via a wired or wireless connection.

[0038] A user may interact with the packaging units 110, 300 via the control system 400 to input patient information, facility information, and / or required medications. The control system 400 may control the operation of the universal supply cartridge 105 to individually dispense medications to the packaging units 110, 300. The control system 400 may also control the operation of the packaging units 110, 300 to form pouches around the dispensed medications.

[0039] 12 illustrates another view of the packaging unit 110, 300. In the illustrated example, the packaging unit 110, 300 also includes a verification system 356. The verification system 356 is located between the feedstock rolls 126, 130 and the take-up roll 134 (or dispenser), downstream of the container 122 and pouch seal forming mechanism 330. An example verification system is described in U.S. Patent Application Publication No. 2007 / 0139994, the entire contents of which are incorporated herein by reference.

[0040] In operation, the automatic packaging machine 100 is used to package batches of drugs, each batch being provided in a separate pouch package. The pouch packages are verified using the verification system 356. By varying the size of the single pouch as described above, the automatic packaging machine 100 can be used to package any number of drugs in a single pouch package. However, a large number of pills in a single pouch can complicate the implementation of verification using the verification system. For example, if a single pouch contains more than seven drugs, the drugs may overlap during the verification process, making it difficult to identify which drug and how much of the drug is in the pouch. Some drugs should be packaged in different pouches to avoid affecting each other (e.g., one drug releases water and another drug absorbs water). Some drugs that are known to be allergenic (e.g., penicillin, etc.) may need to be packaged separately from other drugs. In addition, some expensive drugs (e.g., HIV drugs, etc.) cannot be repackaged or reused if they come into contact with other drugs or substances. In these examples, these expensive drugs are packaged separately in case the drug needs to be reused or repackaged. The exemplary method 500 provided below allows for a single batch of drug to be split into multiple sub-batches for ease of validation.

[0041] 13 is a flow diagram of one example method 500 of packaging medications using the automated packaging machine 100, according to some embodiments. Although the illustrated method 500 includes many illustrative steps, not all of the steps need to be performed in all scenarios. In some embodiments, the method of packaging medications using the automated packaging machine 100 may include only a subset of the steps identified in the flow diagram. In addition, some methods may include additional steps.

[0042] In the method 500, a packaging unit 110 or universal supply cartridge 105 performing a particular function or block may include an electronic processor 410 that controls the packaging unit 110 or universal supply cartridge 105 to perform that function or block.

[0043] In the illustrated example, the method 500 includes determining (at block 504) the drugs in the next batch of drugs using the electronic processor 410. The electronic processor 410 receives a prescription and determines a plurality of batches of drugs based on the prescription. For example, the prescription may prescribe a 30 day supply of drugs, with a first set of drugs for the morning, a second set of drugs for the afternoon, and a third set of drugs for the evening. The electronic processor 410 may divide the sets into batches. For example, the first set for day 1 is the first batch, the second set for day 1 is the second batch, the third set for day 1 is the third batch, and the first set for day 2 is the fourth batch, etc. Thus, the electronic processor 410 may divide the above example prescription into, for example, 90 batches of drugs (e.g., 30 days' supply of 3 batches of drugs per day, etc.). The electronic processor 410 can determine the type and amount of drugs in each batch at the time the batches are made or at the time the drugs are packaged by an automated packaging machine. The amount of drugs may include, for example, the number of drugs in a batch. The type of drug may include determining whether the drug releases moisture, whether the drug absorbs moisture, whether the drug is a known allergen, whether the drug belongs to a class that cannot be repackaged if it has previously been packaged with other drugs, etc.

[0044] The method 500 includes (at block 512) using the electronic processor 410 to determine whether the batch of drugs is to be split based on the drugs in the batch of drugs. As noted above, providing multiple drugs in a single pouch can complicate the validation process. In addition, certain types of drugs cannot be packaged with other drugs. In one embodiment, the electronic processor 410 determines that the batch of drugs is to be split based on the size of the batch of drugs. The electronic processor 410 can determine the size for the batch of drugs based on the amount of drugs in the batch. For example, the electronic processor 410 can determine the type of drugs in the batch and look up the size (e.g., amount) of the drugs from an internal database of the automated packaging machine or, for example, from a database of national drug codes. The electronic processor 410 determines the size for the batch based, for example, on the number of drugs multiplied by their respective sizes.

[0045] The pouch size threshold may be preset in the automated packaging machine. The automated packaging machine 100 may package batches that meet the pouch size threshold (e.g., below the pouch size threshold (e.g., 7 pills)) into a single pouch, as described in blocks 516-528 below, and may package batches that exceed the pouch size threshold into multiple pouches, as described in blocks 532-552 below. The electronic processor 410 compares the size for the batch of medication to the pouch size threshold to determine whether the batch is to be packaged in a single pouch or multiple pouches.

[0046] Additionally, in some embodiments, the electronic processor 410 can further determine whether the batch of drugs contains incompatible drugs. For example, some drugs absorb moisture from the environment and some drugs release moisture to the environment. Therefore, these drugs may not be packaged together to avoid interactions. If the electronic processor 410 determines that the batch of drugs contains incompatible drugs, the electronic processor can divide the batch of drugs into sub-batches such that the incompatible drugs are sealed in separate chambers.

[0047] If the batch of drug can be packaged without splitting, the method 500 includes (at block 516) using the packaging unit 110, 300 to create a pouch (e.g., a first pouch) of a size corresponding to the batch of drug. As described above, each feedstock roll of the packaging equipment releases material 324 to form a pouch. The material 324 from each feedstock roll forms one half of a pouch. The two halves are secured together along three sides or edges (e.g., a bottom and two sides) to close the sides and form a pouch. The pouch may be formed, for example, along a plunger 150, 316.

[0048] In some embodiments, as described above, the printer 352 can print customer information, information about the batch of drugs, and other indicia on the material 324. For example, the printer 352 can print the name, dosage, and other information about the drugs in the pouch on the material 324. The printer 352 can also print indicia (e.g., a black mark) where the intended end of the pouch is expected. The packaging unit uses this indicia in creating a pouch of a size corresponding to the batch of drugs. The size corresponding to the batch of drugs may be slightly larger than the size for the batch of drugs to comfortably accommodate the drugs in the pouch. In some embodiments, the information and indicia on the material 324 is printed before the pouch is created, for example while the previous pouch is being filled by the packaging unit 110, 300.

[0049] The method 500 also includes (at block 520) filling a pouch with a batch of medication using the packaging unit 110, 300. The batch of medication is dispensed from the universal supply cartridge 105. As described above, once the pouch is formed, the plunger 150, 316 can be moved from the pouch to direct the batch of medication into the pouch.

[0050] The method 500 further includes (at block 524) sealing the pouch using the packaging unit 110, 300, and (at block 528) providing the pouch with a serrated edge at the current seal position using the packaging unit 110, 300. The pouch may be provided with a serrated edge, for example, using a cutting mechanism in the packaging unit 110, 300. Once the pouch is filled, the plunger 150, 316 returns to the lowered position (FIG. 8) and helps to push the pharmaceutical product into the pouch. The material 324 is advanced to form the next pouch, for example, for the next batch or sub-batch of drugs. The material 324 may be advanced until an indication on the material 324 is detected. The plunger 316 pushes the pharmaceutical product to move it past and out of the seal forming mechanism 330, so that the seal forming mechanism 330 can create a top seal in the pouch. In some embodiments, the plunger 316 may also actuate a cam-type mechanism that moves the flapper 320 slightly ahead of the movement of the plunger 316. A cutting mechanism may then, at approximately the same time and stroke, create a serrated edge line through the top seal between the pouches to facilitate subsequent separation of the pouches. The method 500 returns to block 504 to determine the amount of drug in the next batch of drug.

[0051] 14A-B illustrate front and back views of a plurality of pouches 600, each containing a single batch of medication 604 located within a single chamber or compartment 608. Each pouch 600 is sealed on all four sides to define a corresponding compartment 608. Adjacent pouches 600 are separated by a serrated edge 612 or other suitable means that contribute to separating the pouches 600 from one another. On one side of each pouch 600 (see FIG. 14A), the pouch 600 includes information about the pouch 600 and the medication 604 contained therein. For example, the illustrated pouch 600 includes date and time information 616 when the medication 604 should be taken, the patient's name 620, information about the medication 624 within the pouch 600, and a scannable feature 628 (e.g., a QR code, barcode, etc.) associated with the pouch 600. Other pertinent information (eg, instructions for taking medication 604, pharmacy information, etc.) may also be printed on pouch 600.

[0052] Such pouches 600 work well when each pouch 600 has a relatively small number of medications (e.g., seven pills or less). However, when more than a threshold number of medications need to be taken at a given time, multiple pouches need to be made to hold all of the medications. In some scenarios, the pouches 600 may be labeled, for example, "1 of 3," "2 of 3," and "3 of 3," etc. Such pouches may be confusing to the patient and / or the patient may forget to take the medications in all of the pouches.

[0053] 13, if the size exceeds the pouch size threshold, the method 500 includes (at block 532) splitting the batch into multiple sub-batches using the electronic processor 410. The electronic processor 410 may split the batch into sub-batches having equal or nearly equal sizes or amounts of drug. Alternatively, the batch may be split into sub-batches having different sizes or amounts of drug. As noted above, some batches of drug may contain incompatible drugs, which are split into separate sub-batches.

[0054] In some embodiments, as described above, the printer 352 can print customer information, information about the batch or sub-batch of drug, and other indicia on the material 324. For example, the printer 352 can print the name, dosage, and other information about the drug in the pouch on the material 324. The printer 352 can also print indicia (e.g., a black mark, etc.) where the end of the intended pouch is expected. The packaging unit uses this indicia when producing a pouch of a size corresponding to the batch of drug. In some embodiments, the information and indicia on the material 324 is printed prior to the production of the pouch, for example, while one of the previous pouches is being filled by the packaging unit 110, 300.

[0055] The method 500 also includes (at block 536) using the packaging unit 110, 300 to make a pouch sized for the sub-batch; (at block 540) using the packaging unit 110, 300 to fill the pouch with the sub-batch of drug; and (at block 544) using the packaging unit 110, 300 to seal the pouch. The pouch is made and sealed as described above in blocks 520 and 524. In some embodiments, the compartments with sub-batches of a single batch of drug are not separated by serrated edges. By not providing the pouch with serrated edges between each compartment, the compartments with sub-batches cannot be easily separated from each other, essentially indicating to the patient that there is an additional drug or pouch to be taken at the prescribed time. Thus, by not providing serrated edges to the sub-batches within a batch, prescription adherence is improved. In systems where serrated edges are provided between the sub-batch pouches, the user may accidentally cut off only a portion of the drug and miss out on taking all of the drug required as prescribed. The difficulty in cutting the pouches by not providing the sub-batch pouches with serrated edges indicates to the user that all of the pouches between the serrated edges are for the current time. In other embodiments, compartments with sub-batches of a single drug batch are separated by serrated edges. In these embodiments, a label may be used to alert the user that all of the compartments belong to the same drug batch. Specifically, the label is continuous and extends across the compartments of the drug batch. Additional indications, such as lines or colors, may be provided to indicate the beginning and end of the drug batch.

[0056] In some embodiments, not providing a serrated edge to the pouch may be accomplished by temporarily moving a cutting mechanism of the packaging unit 110, 300 away from the pouch material. For example, a solenoid, cam-type mechanism, or other suitable actuator may be coupled to the cutting mechanism. The actuator may receive a signal from a control system of the packaging unit 110, 300 to not create a serrated edge for a given pouch as the packaging unit 110, 300 is creating a series of sub-batches. Additionally or alternatively, a cutting block (e.g., a rubber strip) opposite the cutting mechanism may be moved away from the pouch to prevent the cutting mechanism from creating a serrated edge between sub-batches.

[0057] The method 500 includes determining (at block 548) using the electronic processor 410 whether the end of the sub-batch has been reached. The electronic processor 410 determines whether all of the multiple sub-batches of the batch of drug have been packaged into pouches. If the end of the sub-batch has not been reached, the method 500 includes repeating blocks 536-544 until all of the sub-batches of the batch have been sealed into pouches. Once the end of the sub-batch has been reached, the method 500 includes providing a serrated edge to the pouch at the current seal location (at block 552).

[0058] 15A-B illustrate front and back views of a pouch 700 containing multiple drug sub-batches 704 contained within separate compartments 708. The pouch 700 is defined between serrated edges 712 on either end of the pouch 700. The pouch 700 is also designed to contain multiple drug sub-batches 704 without having serrated edges between adjacent compartments 708. In other words, the pouch 700 and each compartment 708 is sealed on all four sides, but the serrated edges 712 are only provided at the beginning and end of the entire pouch 700 (i.e., batch). As such, the individual compartments 708 of a single drug batch cannot be easily separated. In the illustrated embodiment, the pouch 700 contains three compartments 708 separated by heat seals 714 (rather than serrated teeth). In other embodiments, pouch 700 may be separated by heat seal 714 and serrated edges. However, it should be apparent that in other embodiments, pouch 700 may include any number of compartments required for filling a batch of drug.

[0059] Similar to pouch 600 of FIG. 14A, one side of the illustrated pouch 700 (FIG. 15A) includes information about the pouch 700 and the medication 704 therein. For example, pouch 700 includes date and time information 716 regarding the time the medication 704 should be taken, the patient's name 720, information about the medication 724 in the pouch 700, and a scannable feature 728 (e.g., a QR code, barcode, etc.) associated with the pouch 700. In some embodiments, the information about the medication 724 may be printed to match the compartment that contains the particular medication. For example, if drug A is provided in a first compartment and drug B is provided in a second compartment, the information about drug A 724 is printed on a portion of a label directly over the first compartment and the information about drug B 724 is printed on a portion of a label directly over the second compartment. In other embodiments, the information regarding the medication 724 may not line up precisely with each compartment due to the date and time information 716, the patient name 720, and the size of the compartments. In such embodiments, the information regarding the medication 724 may still be presented in the order of the compartments. For example, one or more medications 704 in a first compartment may be listed first, followed by one or more medications 704 in a second compartment. Other relevant information (e.g., instructions for taking the medication 704, pharmacy information, etc.) may also be printed on the pouch 700. However, unlike conventional pouches, the date and time information 716, the patient name 720, and the scannable features 728 are not reprinted for each compartment 708 or sub-batch of medication. Rather, this information is printed only once, giving the sub-batch the appearance of a single, continuous pouch.

[0060] Additionally, the illustrated pouch 700 includes a continuous identifier that spans the batch's multiple compartments 708. In the illustrated embodiment, the identifier includes a border 732. In other embodiments, the identifier may also or alternatively include images, graphics, watermarks, lines, colors, and the like that span the batch's multiple compartments 708. Although the identifier further enhances the appearance of one continuous pouch, the pouch still has multiple separate compartments 708 for having a greater number of medications and / or incompatible medications.

[0061] In some embodiments, as described above with respect to FIG. 12, the packaging unit 110 includes a sensor 338 to detect a drug that obstructs the seal formation area 334 (FIG. 8) of the pouch. The electronic processor 410 is configured to detect the drug in the seal formation area 334 of the pouch using the sensor 338. The sensor 338 may be, for example, a camera, an infrared sensor, and / or an optical sensor. In response to detecting the drug in the seal formation area, the electronic processor 410 is configured to stop the seal formation of the pouch. By stopping the seal formation of the pouch, crushing of the drug and incorrect packaging of the pouch is prevented. In some embodiments, the electronic processor 410 generates an alert in response to detecting the drug in the seal formation area. The alert may be in the form of an audible sound or alarm generated at the packaging unit 110, an audible sound or visual alarm generated at a device or interface used to verify the pouch, and the like. In some embodiments, the electronic processor 410 is also configured to detect the drug in the path to the pouch using sensors provided along the track 138. In response to detecting medication in the path to the pouch, the electronic processor 410 can prevent the pouch from sealing and generate the alarm described above.

[0062] The electronic processor 410 may resume packaging in response to detecting that the drug is cleared from the seal forming area 334 and / or the track 138. For example, the electronic processor 410 may receive a signal from the sensor 338 indicating that there is no drug in the seal forming area 334. The drug may be cleared by, for example, a user tapping the packaging unit 110 after opening a cabinet door of the packaging unit 110 and / or by physically removing the drug. In some embodiments, a vibration mechanism may be provided in the seal forming mechanism to clear the seal forming area 334. The vibration mechanism may be activated by a vibration motor provided in the seal forming mechanism 330. In response to detecting the drug in the seal forming area 334 and / or the track 138, the electronic processor 410 activates the vibration mechanism to vibrate the pouch and further remove the drug from the seal forming area 334.

[0063] Various features and advantages of the invention are set forth in the following claims.

Claims

1. 1. An automated packaging machine for packaging drugs, comprising: a cartridge for dispensing said medication; a packaging unit for receiving the drug dispensed from the cartridge; an electronic processor electrically coupled to the cartridge and the packaging unit; Determining the drugs in a batch of drugs; determining whether the batch of drug is to be split based on the drugs in the batch of drug; responsive to determining that the batch of drug will be divided, dividing the batch of drug into a plurality of sub-batches of drug; using said packaging unit to produce a pouch containing a plurality of separate compartments corresponding to said sub-batches of drugs; using said packaging unit to fill said plurality of separate compartments with sub-batches of said plurality of drugs; an electronic processor configured to Including automatic packaging machine.

2. The electronic processor includes: determining a size for the batch of drugs based on the drugs in the batch of drugs; determining whether a size for the batch of drug is greater than a pouch size threshold; and determining that the batch of drug will be divided if the batch of drug is larger than the pouch size threshold; The automatic packaging machine of claim 1 further configured to:

3. The electronic processor includes: determining whether the batch of drugs includes an incompatible drug based on the drugs in the batch of drugs; determining that the batch of drug will be split if the batch of drug contains an incompatible drug; The automatic packaging machine of claim 1 further configured to:

4. The electronic processor includes: using said packaging unit to seal said plurality of separate compartments without having serrated edges between adjacent compartments; in response to determining that a sub-batch of the plurality of drugs is to be packaged, providing the pouch with a serrated edge at an end of the pouch. The automatic packaging machine of claim 1 further configured to:

5. The electronic processor includes: Determining the drugs in the second batch of drugs; determining, based on the drugs in the second batch of drug, that the second batch of drug is not to be split; in response to determining that the second batch of drug is not to be divided, filling a second pouch with the second batch of drug using the packaging unit without creating a compartment; Using the packaging unit to provide a seal and a serrated edge to the second pouch at an end of the second pouch. The automatic packaging machine of claim 1 further configured to:

6. 2. The automated packaging machine of claim 1, wherein the electronic processor is further configured to print a consecutive identifier on the pouches that provides the appearance of one continuous pouch across a subset of the plurality of separate compartments.

7. The packaging unit comprises: a packaging device operable to form the pouch; a truck configured to direct the medication to the packaging device; a container coupled to the track for receiving the medication from the track, the pouch being formed within the container; and a seal forming mechanism for sealing the pouch along a seal forming area of ​​the pouch after the medication is received within the pouch; The automatic packaging machine of claim 1 further comprising:

8. The packaging unit further includes a sensor configured to detect whether a drug is within the seal forming area, and the electronic processor further comprises: Detecting a drug within the seal-forming area using the sensor; in response to detecting the drug within the seal formation area, ceasing to seal the pouch; The automatic packaging machine of claim 7 further configured to:

9. The automated packaging machine of claim 8 , wherein the electronic processor is further configured to generate an alert in response to detecting a drug in the seal forming area.

10. 9. The automated packaging machine of claim 8, wherein the electronic processor is configured to, in response to detecting a drug in the seal forming area, activate a vibration mechanism configured to vibrate the pouch to displace the drug from the seal forming area.

11. 1. A method of packaging a drug using an automated packaging machine, comprising: determining, using an electronic processor of the automated packaging machine, the drugs in the batch of drugs; determining, using the electronic processor, based on the drugs in the batch of drugs, whether the batch of drugs is to be split; using the electronic processor, in response to determining that the batch of drug is to be divided, dividing the batch of drug into a plurality of sub-batches of drug; using a packaging unit of the automated packaging machine to create a pouch including a plurality of separate compartments corresponding to the sub-batches of the plurality of drugs; filling said plurality of separate compartments with sub-batches of said plurality of drugs using said packaging unit; The method includes:

12. determining a size for the batch of drugs based on the drugs in the batch of drugs using the electronic processor; determining, using said electronic processor, whether a size for said batch of medication is greater than a threshold pouch size; determining, using the electronic processor, that the batch of medication will be split if the batch of medication is larger than the pouch size threshold; The method of claim 11 further comprising:

13. determining, using the electronic processor, whether the batch of medications includes an incompatible medication based on the medications in the batch of medications; determining, using the electronic processor, that if the batch of medication contains an incompatible medication, the batch of medication will be split; The method of claim 11 further comprising:

14. using the packaging unit to seal the plurality of separate compartments without serrated edges at seal locations between adjacent compartments; in response to determining that the packaging unit is to be used to package a sub-batch of the plurality of drugs, providing the pouch with a serrated edge at an end of the pouch; The method of claim 11 further comprising:

15. The electronic processor includes: determining a drug in a batch of a second drug using said electronic processor; determining, using the electronic processor, based on the drugs in the batch of the second drug, that the batch of the second drug is not to be split; in response to determining that the second batch of drug is not to be divided, filling a second pouch with the second batch of drug using the packaging unit without creating a compartment; providing a seal and a serrated edge to the second pouch at an end of the second pouch using the packaging unit; The method of claim 11 further comprising:

16. 12. The method of claim 11, further comprising using the packaging unit to print a consecutive identifier on the pouches across a subset of the plurality of separate compartments to provide the appearance of one continuous pouch.

17. forming the pouch with a packaging machine; directing the medication along a track to the packaging device; receiving the medication from the track in a container, wherein a pouch is formed in the container, and after the medication is received in the pouch, the pouch is sealed using a seal forming mechanism along a seal forming area of ​​the pouch; detecting a drug substance in the seal-forming area using a sensor; using the electronic processor to stop sealing the pouch in response to detecting a drug in the seal formation area; generating an alert in response to detecting a drug in the seal-forming area using the electronic processor; using the electronic processor, in response to detecting a medication in the seal-forming area, activating a vibration mechanism configured to vibrate the pouch to displace the medication from the seal-forming area; The method of claim 11 further comprising:

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