Pharmaceutical packaging systems and pouches

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] FIELD OF THE INVENTION 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] U.S. Patent Application Publication No. 2019 / 0112080 [Patent Document 2] U.S. Patent Application Publication No. 2013 / 0318931 [Patent Document 3] U.S. 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 holding 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 heat seals, but not by serrations. 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 that receives 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 drug batch and, based on the drugs in the drug batch, determine whether the drug batch is to be split. The electronic processor is also configured, in response to determining that the drug batch is to be split, to split the drug batch into multiple drug sub-batches and, using the packaging unit, to create pouches including multiple compartments corresponding to the multiple drug sub-batches. The electronic processor is further configured to fill the multiple compartments with the multiple 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, splitting 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 using a packaging unit to create a pouch including a plurality of compartments corresponding to the plurality of drug sub-batches. The method further includes using the packaging unit to fill the plurality of compartments with the plurality of drug sub-batches. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 illustrates a front perspective view of an automatic packaging machine, according to some embodiments. [Figure 2] 2 is a perspective view of a packaging unit of the automatic packaging machine of FIG. 1, according to some embodiments. [Figure 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. [Figure 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 a pharmaceutical product packaged inside, according to some embodiments. [Figure 8] 2 illustrates a portion of a packaging unit of the automatic 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 INVENTION

[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 arrangement 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 of being carried out in various ways.

[0009] FIG. 1 illustrates an exemplary 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 simultaneously dispense up to 20 separate pills. In the configuration illustrated in FIG. 1 including the universal supply cartridge 105, the automated packaging machine 100 can be used to simultaneously dispense and package 20 different pills. An exemplary universal supply cartridge is described in U.S. Patent Application Publication No. 2006 / 0129994, the entire contents of which are incorporated herein by reference.

[0010] 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. 5,629,999 and 5,729,999, the contents of which are incorporated herein by reference in their entireties. Figure 1 illustrates merely an example 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] Figures 2-6 illustrate one embodiment of a packaging unit 110 for use with an automatic 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] As shown in FIGS. 2 and 3, the manifold 118 includes a plurality of separate tracks 138 corresponding to each of the cartridges of a universal supply cartridge 105 attached to the base 114. The illustrated tracks 138 are independent channels that together form the manifold 118. The tracks 138 separate the pharmaceuticals from each other as the pharmaceuticals slide down the manifold 118 to the container 122.

[0013] As shown in FIG. 3, a camera 142 is attached to the base 114 adjacent to the discharge port within the base 114. Each camera 142 is associated with one of the cartridges of the universal supply cartridge 105 supported on the base 114. The camera 142 is operable to determine whether the appropriate number and / or type of pharmaceuticals are being dispensed from the universal supply cartridge 105. The camera 142 captures an image of the pharmaceuticals exiting the base 114 and compares the characteristics of the pharmaceuticals (e.g., color, contour, size, shape, markings, etc.) to stored images of the pharmaceuticals. In some embodiments, recognition software can be utilized to automatically compare the images captured by the camera 142 to the stored images. In other embodiments, the captured image is sent to a pharmacist or technician located remotely, and the pharmacist or technician analyzes the image and confirms that the correct number and type of pharmaceuticals have been dispensed. In further embodiments, the camera 142 may be an infrared sensor that only detects whether an object (e.g., a pill, etc.) is falling through the base 114 rather than identifying a particular type of pharmaceutical.

[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 temporarily 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] During operation, plunger 150 is initially in a lowered position ( FIG. 5 ) to temporarily suspend the medication. Plunger 150 remains in this position until all requested medications are collected in receptacle 122. If an excess or incorrect medication (as may be determined by camera 142) is dispensed from universal supply cartridge 105, an air jet, deflector, or trap door can be utilized to remove the medication from receptacle 122 or from manifold 118 before it reaches receptacle 122. In some embodiments, detecting an excess or incorrect medication can include inspecting the medication as it is in flight (e.g., falling from base 114 into manifold 118) as it is released from universal supply cartridge 105. Camera 142 mounted on base 114 can be used to identify each dispensed medication, for example, by reading markings on the pill. Camera 142 can be a high-speed camera and can include a prism and / or mirror to capture a full 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 was dispensed from universal supply cartridge 105. Once the correct medication is in 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 an opaque and / or non-plastic material. 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, medication type, etc.) is printed on the pouch 200 using, for example, a thermal printer, an inkjet printer, or a thermal transfer ribbon. In other embodiments, the identifying indicia 220 may be printed on a label that is attached to the pouch 200 using an adhesive. In further embodiments, the pouch 200 may include a header and / or footer area that is drug-free, but that provides space for printing or applying the indicia 220. In some embodiments, the packaging unit 110 can 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, 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 above-described packaging unit 110.

[0018] In the illustrated embodiment, packaging unit 300 includes a container 304 for controlling pharmaceuticals (e.g., pills P) as they are packaged into pouches (e.g., pouch 200 shown in FIG. 7). Container 304 receives 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 pouches. In other embodiments, the packaging equipment may include a single feedstock roll. Container 304 is located upstream of the packaging equipment and receives the pharmaceuticals from the tracks before they 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 a track to receive the medication. The valve mechanism 312 blocks the medication 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 prevents the medication from leaving the collection area 308 and traveling toward the packaging equipment. When in the raised position, the plunger 316 is displaced to allow the medication 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 manage material 324 being discharged by a feedstock roll of the packaging equipment to form a pouch. In particular, the flapper 320 extends within a channel 328 between the collection area 308 and the packaging equipment and engages the material 324 to prevent the material 324 from tearing or bonding. Additionally, the flapper 320 helps hold the edges of the material 324 close together to form a seal. In the illustrated embodiment, the flapper 320 is pivotable relative to the channel 328 about a pivot shaft 331. In other embodiments, the flapper 320 may move linearly relative to the channel 328. In some embodiments, the flapper 320 may be biased within the channel 328 by, for example, a spring.

[0021] In some embodiments, the flapper 320 can 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 above 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 a 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 tip of the flapper 320 presses 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 curve-out may generally match the shape and contour of the plunger 316. The curve-out provides an opening for the medication to travel 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, thereby closing the top edge of the pouch.

[0023] In some embodiments, the plunger 316 is held between the strips of material 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., a bottom edge and two side edges). This seal-forming process can be performed 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 plunger 316. By creating a seal around the plunger 316, the two strips of material 324 are connected together but do not lie flat against each other. When the plunger 316 moves to its raised position ( FIG. 9 ), the plunger 316 is removed from between the two strips of material 324, leaving the pouch open at the top. As described further below, the plunger 316 can be returned to its lowered position ( FIG. 8 ), helping to force 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 pouch separation. Alternatively, the cutting mechanism can separate the pouches at the seal when they are complete.

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

[0025] Referring again to FIGS. 8 and 9 , during operation, the valve mechanism 312 physically pushes the medications into the pouches to fill them, rather than relying on gravity to drop them into the pouches. In particular, the plunger 316 of the valve mechanism 312 is initially in a lowered position ( FIG. 8 ) as the container 304 receives the medications from the track. While in the lowered position, the plunger 316 blocks the medications from traveling to the packaging equipment, so that all of the medications are initially collected in the collection area 308. Blocking the medications with the valve mechanism 312 allows the medications to settle together toward the bottom of the collection area 308 while the previous pouch is still sealed. The valve mechanism 312 prevents medications 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 prevents medications 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 prevent 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 the pouch. The two halves are fastened 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 from about 1 inch to about 3 1 / 4 inches are made, although pouches of other lengths are also 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 material 324 by an index mark (e.g., a black line) painted on material 324. When the packaging equipment sees this mark, the feedstock roll stops discharging material 324. In embodiments where the packaging equipment includes only a single feedstock roll, material 324 from the single roll may be folded along one side or edge to close that edge. In either embodiment, material 324 may be pre-printed with pharmaceutical and patient-related indicia. After the pouch is initially formed, one of the heat seal elements separates from 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, it is positioned 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., the 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 arches one of the strips of material 324 relative to the other strip of material 324. This arrangement prevents the arched strip of material 324 from flattening against the other strip of material 324, making it easier for the pharmaceutical product to fill the pouch. Additionally, when plunger 316 is removed from the pouch, a hole or gap is left between the top edges of material 324, allowing the medication to move more easily into the pouch.

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

[0029] In other embodiments, once all of the required medication has been collected in collection area 308 and the pouch has been formed, plunger 316 moves to its raised position (FIG. 9). The medication then falls from collection area 308 toward flapper 320, which, in some embodiments, blocks path 328 to the packaging equipment. Plunger 316 then returns to its lowered position (FIG. 8), helping to force the medication into the pouch. Material 324 is advanced by the packaging equipment at approximately the same speed as plunger 316 moves, so 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, plunger 316 pushes the medication past and away from seal-forming mechanism 330, allowing seal-forming mechanism 330 to create a top seal within 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 force the medication into the pouch, more medication can be more reliably loaded into the pouch. For example, in some embodiments, the plunger 316 may be used to load 10 to 40 medications into a single pouch. Loading such a quantity of medication into a pouch may not be achievable by relying solely on gravity. Additionally, such an arrangement allows more medications to be loaded into a single pouch than with conventional devices, which reduces the potential for patient confusion by providing all of the medications in a single pouch (rather than multiple pouches each containing a small number of 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 roll, the fourth side or edge (e.g., the top) of the pouch is closed by a seal-forming mechanism 330. Like the other sides, the fourth side of the pouch can be closed by, for example, heat sealing. As mentioned above, the seal forming 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] Seal forming mechanism 330 creates a top seal along the seal forming region of the pouch (e.g., along serrated edges 340, 612, 712 or along heat seal 714 without a serrated edge). If a medication is present in seal forming region 334 of the pouch, seal forming mechanism 330 may crush or destroy the medication, rendering it unusable for distribution. To prevent this damage, a sensor 338 (e.g., a camera, etc.) may be provided with seal forming mechanism 330 (see FIG. 12 ) to detect medication that may be obstructing seal forming region 334. Packaging unit 300 may stop sealing the pouch if sensor 338 detects medication. In some embodiments, seal forming mechanism 330 may be provided with a vibration mechanism to vibrate the pouch to induce the medication to settle from seal forming region 334 into the pouch. In some embodiments, sensors (e.g., cameras, etc.) may also be provided along track 138 to detect whether medication is stuck in track 138 and cannot reach the pouch. If the sensors in track 138 detect medication stuck in the track, the pouch can be prevented from being sealed. In particular, the sensors in track 138 detect whether 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 pharmaceuticals more accurately, faster, and at higher 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's name, the 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, processor 410 is implemented as a microprocessor with a separate memory, such as memory 420. In other embodiments, processor 410 may be implemented as a microcontroller (with memory 420 on the same chip). In other embodiments, processor 410 may be implemented using multiple processors. Additionally, processor 410 may be implemented partially or entirely as, for example, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), etc., and memory 420 may not be required or modified accordingly. In the illustrated example, memory 420 includes non-transitory computer-readable memory that stores instructions received and executed by processor 410 to perform the functions of control system 400 described herein. Memory 420 may include, for example, a program storage area and a data storage area. The program storage area and 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 server at a remote pharmacist, a smartphone, 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 touchscreen, keypad, buttons, knobs, etc.), one or more output mechanisms (e.g., a display, 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 to or in addition to managing input and output via the input / output interface 440, the control system 400 can 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 can 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 can control the operation of the universal supply cartridge 105 to individually dispense medications into the packaging units 110, 300. The control system 400 can 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 exemplary verification system is described in U.S. Patent Application Publication No. 2007 / 0129994, the entire contents of which are incorporated herein by reference.

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

[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, a 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, the 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, method 500 includes (at block 504) determining, using electronic processor 410, the drugs in the next batch of drugs. Electronic processor 410 receives a prescription and determines multiple 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 morning use, a second set of drugs for midday use, and a third set of drugs for evening use. 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, electronic processor 410 may divide the above example prescription into, for example, 90 batches of drugs (e.g., 30 days of three batches of drugs per day, etc.). The electronic processor 410 can determine the type and amount of medication in each batch at the time the batch is made or the medications are packaged by an automated packaging machine. The amount of medication may include, for example, the number of medications in the batch. The type of medication may include determining whether the medication releases moisture, whether the medication absorbs moisture, whether the medication is a known allergen, and whether the medication belongs to a class that cannot be repackaged if previously packaged with other medications, etc.

[0044] Method 500 includes (at block 512) using electronic processor 410 to determine whether a batch of drugs is to be split based on the drugs in the batch. As noted above, providing multiple drugs in a single pouch can complicate the verification process. Additionally, certain types of drugs cannot be packaged with other drugs. In one embodiment, electronic processor 410 determines that a batch of drugs is to be split based on the size of the batch of drugs. Electronic processor 410 can determine the size for the batch of drugs based on the amount of drugs in the batch. For example, electronic processor 410 can determine the type of drugs in the batch and retrieve 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. 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 can package batches that meet the pouch size threshold (e.g., below a pouch size threshold (e.g., seven pills)) into a single pouch, as described in blocks 516-528 below, and can 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 will be packaged in a single pouch or multiple pouches.

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

[0047] If the batch of drug can be packaged without division, 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 discharges material 324 to form a pouch. The material 324 from each feedstock roll forms one half of a pouch. The two halves are fastened together along three sides or edges (e.g., a bottom and two side edges) to close the sides and form the pouch. The pouch may be formed, for example, along a plunger 150, 316.

[0048] In some embodiments, as described above, printer 352 can print customer information, information about the batch of drugs, and other indicia onto material 324. For example, printer 352 can print the name, dosage, and other information about the drugs in the pouch onto material 324. Printer 352 can also print indicia (e.g., black marks) where the intended pouch edge is expected. The packaging unit uses this indicia when creating pouches 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 within the pouch. In some embodiments, the information and indicia on material 324 are printed before the pouches are created, for example, while the previous pouch is being filled by 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) using the packaging unit 110, 300 to impart a serrated edge to the pouch at the current seal position. The pouch may be imparted with a serrated edge, for example, using a cutting mechanism within the packaging unit 110, 300. Once the pouch is filled, the plunger 150, 316 returns to the lowered position ( FIG. 8 ) and helps push the medication into the pouch. The material 324 is advanced to form the next pouch, for example, for the next batch or sub-batch of medication. The material 324 may be advanced until an indicia on the material 324 is detected. The plunger 316 pushes the medication past and away from the seal-forming mechanism 330, so that the seal-forming mechanism 330 can create a top seal within 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 medication batch 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 to help separate 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 for 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 contains a relatively small number of medications (e.g., seven pills or less). However, if more than a threshold number of medications need to be taken at a given time, multiple pouches must be created to contain all of the medications. In some scenarios, pouches 600 may be labeled, for example, "1 of 3," "2 of 3," and "3 of 3," etc. Such pouches may be confusing for patients and / or they may forget to take the medications in all of the pouches.

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

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

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

[0056] In some embodiments, not providing a serrated edge to the pouch may be achieved by temporarily moving the 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 the control system of the packaging unit 110, 300 to not create a serrated edge for a given pouch as the packaging unit 110, 300 produces 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] Method 500 includes determining (at block 548) using electronic processor 410 whether the end of the sub-batch has been reached. Electronic processor 410 determines whether all of the multiple sub-batches of the batch of medication have been packaged into pouches. If the end of the sub-batch has not been reached, method 500 includes repeating blocks 536-544 until all of the sub-batches of the batch have been sealed into pouches. If the end of the sub-batch has been reached, 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 are 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., the 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 illustrated pouch 700 ( FIG. 15A ) includes information about the pouch 700 and the medication 704 contained 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 within pouch 700, and a scannable feature 728 (e.g., a QR code, barcode, etc.) associated with pouch 700. In some embodiments, the information about medication 724 may be printed to match the compartment containing the particular medication. For example, if medication A is provided in a first compartment and medication B is provided in a second compartment, the information about medication A 724 would be printed on a portion of a label directly over the first compartment, and the information about medication B 724 would be printed on a portion of a label directly over the second compartment. In other embodiments, the information about the medications 724 may not align precisely with each compartment due to the date and time information 716, patient name 720, and compartment size. In such embodiments, the information about the medications 724 may still be presented in compartment order. 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 medications 704, pharmacy information, etc.) may also be printed on the pouch 700. However, unlike conventional pouches, the date and time information 716, patient name 720, and 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. While the identifier further enhances the appearance of a single, continuous pouch, the pouch still has multiple separate compartments 708 for holding 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 medication interfering with the seal-forming area 334 ( FIG. 8 ) of the pouch. The electronic processor 410 is configured to use the sensor 338 to detect medication within the seal-forming area 334 of the pouch. The sensor 338 may be, for example, a camera, an infrared sensor, an optical sensor, or the like. In response to detecting medication within the seal-forming area, the electronic processor 410 is configured to stop the seal formation of the pouch. Stopping the seal formation of the pouch prevents crushing of the medication and incorrect packaging of the pouch. In some embodiments, the electronic processor 410 generates an alert in response to detecting medication within the seal-forming 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, or the like. In some embodiments, the electronic processor 410 is also configured to detect medication within the path to the pouch using sensors located along the track 138. In response to detecting the drug 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 medication 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 the medication is no longer in the seal forming area 334. The medication may be cleared by, for example, a user tapping the packaging unit 110 after opening the cabinet door of the packaging unit 110 and / or by physically removing the medication. 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 medication 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 medication 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 automatic 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 medication is to be split based on the medications in the batch of medication; 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, the packaging unit includes a container for receiving the drug dispensed from the cartridge, the container including a plunger that is in a lowered position to prevent the drug from passing to the pouch or that is in a raised position to allow the drug to pass to the pouch; The automatic packaging machine, wherein the plunger is in the lowered position after passing the drug, thereby pushing the drug and moving it beyond and away from the seal-forming area within the pouch.

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

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

5. The electronic processor determining the drugs in the second batch of drugs; determining, based on the drugs in the batch of second drug, that the batch of second drug will not be split; in response to determining that the second batch of drug is not to be split, 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 serrated edges to the second pouch at the end of the second pouch. The automatic packaging machine of claim 1 further configured to:

6. 10. 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; a seal-forming mechanism for sealing the pouch along the 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 present in the seal-forming area, and the electronic processor using the sensor to detect a drug within the seal-forming area; ceasing sealing of the pouch in response to detecting the drug within the seal-forming region; 8. 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 automatic packaging machine of claim 8, wherein the electronic processor is configured to, in response to detecting a medication in the seal-forming area, activate a vibration mechanism configured to vibrate the pouch to displace the medication from the seal-forming area.

11. 1. A method of packaging a drug using an automated packaging machine, comprising: determining the drugs in the batch of drugs using an electronic processor of the automated packaging machine; using the electronic processor to determine whether the batch of medication is to be split based on the medications in the batch of medication; using the electronic processor, in response to determining that the batch of drug will 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 produce pouches containing a plurality of separate compartments corresponding to the sub-batches of the plurality of drugs; using the packaging unit to fill the plurality of separate compartments with sub-batches of the plurality of drugs; Including, the packaging unit includes a container for receiving the drug dispensed from the cartridge, the container including a plunger that is in a lowered position to prevent the drug from passing to the pouch or that is in a raised position to allow the drug to pass to the pouch; The method wherein the plunger is in the lowered position after passing the medication, thereby pushing the medication past and away from the seal-forming area within the pouch.

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

13. using the electronic processor to determine 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; providing the pouch with a serrated edge at an end of the pouch in response to determining that the packaging unit will be used to package a sub-batch of the plurality of drugs; The method of claim 11 further comprising:

15. The electronic processor determining the drugs in the batch of the second drug using the electronic processor; using the electronic processor to determine, based on the drugs in the batch of second drug, that the batch of second drug is not to be split; in response to determining that the second batch of drug is not to be split, 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 serrated edges to the second pouch at an end of the second pouch; 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 using packaging equipment; directing the medication along a track to the packaging device; receiving the medication from the track in the container, wherein the pouch is formed in the container, and the pouch is sealed using a seal forming mechanism along the seal forming region of the pouch after the medication is received in the pouch; detecting a drug 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-forming area; generating an alert using the electronic processor in response to detecting a drug in the seal-forming region; 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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