Patent Description:
Compounding involves the preparation of customized fluid ingredients including medications, nutritional liquids, and/or pharmaceuticals, on a patient-by-patient basis. Compounded medications and solutions can be made on an as needed basis whereby individual components are mixed together to form a unique solution having the strength and dosage needed by the patient. This method allows the compounding pharmacist to work with the patient and/or the prescriber to customize a medication to meet the patient's specific needs. Alternatively, compounding can involve the use of a compounding device to produce compounds in an anticipatory fashion, such as when a future or imminent demand for a particular combination of medicaments or pharmaceuticals or other compound components is known. Further, compounding devices can be used to produce pooled bags, for example, that include certain fluids that are needed for either a number of patients or for the same patient for a number of days or a number of administrations. Thus, the pooled bag(s) can be used by including further specific compounding components, if any, either for a specific patient or for a specific timing for the same patient.

Compounding devices typically use three types of measuring methods: gravimetric (e.g., additive gravimetric (weight final container) or subtractive gravimetric (weight the source containers as the pump delivers)), volumetric, or a combination of gravimetric and volumetric where each type can be used to check the other type. Compounders can be further broken down into three categories based on the minimum volumes they can deliver and the number of components they can accommodate: macro, micro, or macro/micro. Compounders typically have a stated minimum measurable volume and accuracy range. When compounding, higher volumes usually have larger absolute deviations, but lower percentage deviations. Operating software has been used to maximize the effectiveness and efficiency of compounding devices.

Gravimetric devices generally use a peristaltic pump mechanism combined with a weight scale or load cell to measure volume delivered. The volume delivered is calculated by dividing the weight delivered by the specific gravity of the ingredient. Gravimetric devices are not typically affected by running the source containers empty and delivering air into the final bag. These devices can be calibrated by using a reference weight for each ingredient. For example, the device's load cell can be calibrated using a reference mass on the load cell, and individual amounts of fluid dispensed measured by the load cell can be corrected based on the specific gravity of the fluid being dispensed.

Volumetric devices generally use both a peristaltic pump mechanism and a "stepper" motor to turn the pump mechanism in precisely measurable increments. The device calculates the volume delivered by the precision of the delivery mechanism, internal diameter of the pump tubing, viscosity of the solution, and the diameter and length of the distal and proximal tubing. Delivery from these devices can be affected by many factors including: variances in the pump tubing's material, length, elasticity, and diameter; temperature, which affects solution viscosity and tubing size; total volume pumped; ingredient head height; final bag height; position (e.g., initial and final positions) of the pump rollers relative to the pump platens; and empty source components. Thickness of the pump tubing can significantly affect delivery accuracy, and wear on the pumps over time can also cause diminishing accuracy.

Monitoring and replacing source containers before they are empty can prevent the volumetric devices from delivering air in lieu of the ingredient to the final container.

In some cases, due to injury, disease, or trauma, a patient may need to receive all or some of his or her nutritional requirements intravenously. In this situation, the patient will typically receive a basic solution containing a mixture of amino acids, dextrose, and fat emulsions, which can provide a major portion of the patient's nutritional needs. These mixtures are commonly referred to as parenteral mixtures ("PN"). Parenteral mixtures that do not include lipids are commonly referred to as total parenteral nutritional mixtures ("TPN"), while parenteral mixtures containing lipids are referred to as total nutritional admixtures ("TNA"). Often, to maintain a patient for an extended period of time on a PN, smaller volumes of additional additives, such as vitamins, minerals, electrolytes, etc., are also prescribed for inclusion in the mix.

Compounding devices facilitate the preparation of PN mixtures in accordance with the instructions provided by a medical professional, such as a doctor, nurse, pharmacist, veterinarian, nutritionist, engineer, or other. Compounding devices typically provide an interface that allows the medical professional to input, view, and verify the dosage and composition of the PN to be prepared and afterward confirm what had been compounded. The compounding device also typically includes source containers (i.e., bottles, bags, syringes, vials, etc.) that contain various solutions that can be part of the prescribed PN. The source containers can be hung from a framework that is part of the compounding device or can be mounted to a hood bar that is either part of or separate from the compounding device. A single pump or a plurality of pumps may be provided which, under the control of a controller, pump the selected solutions into a final container, for example, a receiving bag. The receiving bag is typically set on a load cell while being filled so that it can be weighed to ensure that the correct amount of solution is prepared. Once the bag has been filled, it can be released from the compounding device and, in this exemplary embodiment, can be used as a reservoir for intravenous infusion to a patient. Compounding devices are typically designed for operation in aseptic conditions when compounding pharmaceutical or neutraceutical ingredients. One example of a compounding device is described in <CIT>, wherein a fluid transfer tubing set assembly is used to transfer individual fluids from multiple supply containers to a single receiving container. In <CIT>, another apparatus for compounding an admixture solution from at least one source solution is disclosed. Furthermore, other examples of devices for compounding and dispensing fluids from a plurality of additives contained in individual vials are disclosed in <CIT> and <CIT>. Further, in <CIT> a peristaltic pumping apparatus comprising a valve assembly is described. Moreover, in <CIT> a method for providing input data to a pharmaceutical compounding device is described. Further, in <CIT> a system for performing peritoneal dialysis comprising a liquid distributing cassette is described. Furthermore, in <CIT> a fluid delivery system comprising multiple fluid sources connected to a pump including multiple pump cylinders via an inlet selector valve is described. Further, in <CIT> a liquid supply set comprising supply bottles each connected via a line to a manifold and from there to a bag is described. Moreover, in <CIT> a modular cassette infusion system comprising inlet valves and outlet valves that can be actuated by pistons is described.

When pharmaceuticals are used, a pharmacist can review instructions that are sent to the compounding device to ensure an improper mixture does not occur. The pharmacist can also ensure the specific sequencing of fluids/liquids is appropriate.

In the medical field, compounding devices can be used to compound fluids and/or drugs in support of chemotherapy, cardioplegia, therapies involving the administration of antibiotics and/or blood products therapies, and in biotechnology processing, including diagnostic solution preparation and solution preparation for cellular and molecular process development. Furthermore, compounding devices can be used to compound fluids outside the medical field.

Recently, there have been efforts to provide a compounding device that can operate more efficiently, with less downtime during source container replacement, and with increased usability features promoting more intuitive use of the system, as well as bubble and/or occlusion sensor mechanisms that cause fewer nuisance alarms.

Accordingly, it may be beneficial to provide a compounding device, system, method, kit or software that operates more efficiently, improves set up time, and reduces downtime when an ingredient runs out and needs replacement, and which provides an aesthetically pleasing and intuitively operational structure, method of set up and use, and an associated usable, efficient and aesthetically pleasing computer interface. Certain embodiments of the disclosed subject matter also increase accuracy at small dispensed volumes, provide a form factor that promotes easier cleaning/disinfecting to maintain aseptic conditions, and also prevent errors, especially in transfer set/fluid path connections.

According to the disclosure, a compounding device for transferring materials from at least two distinct material sources to a final container, comprising the features of the independent claim <NUM> is disclosed.

Advantageous further embodiments are the subject of the dependent claims.

According to another aspect of the disclosure, a method for compounding materials from a plurality of source containers into a final container includes: providing a micro pump, a macro pump, a first material source including a first material, a second material source including a second material, a third material source including a third material, a final container, and a controller; operating the micro pump via the controller to transfer the first material from the first material source to the final container; operating the macro pump via the controller to transfer the second material from the second material source to the final container; operating one of the micro pump and the macro pump via the controller to transfer the third material from the third material source to the final container; and mixing the first material, second material, and third material at a location downstream of the micro pump and the macro pump.

The disclosed subject matter of the present application will now be described in more detail with reference to exemplary embodiments of the apparatus and method, given by way of example, and with reference to the accompanying drawings, in which:.

<FIG> and <FIG> are two different perspective views of an exemplary embodiment of a compounding system <NUM> made in accordance with principles of the disclosed subject matter, with safety lids which are also hereinafter referred to as a sensor bridge cover 10f and a pump cover <NUM> in a closed position and opened position, respectively. The system <NUM> can be used to compound or combine various fluids from small or large containers 4a, 4b and consolidate the fluids into a single/final container, such as an intravenous fluid bag <NUM>, for delivery to a human or animal patient, or to a lab for diagnostics, or to a storage facility for later sales or use. In one example, the system <NUM> can include a plurality of small supply containers 4a and large supply containers 4b each attached to an ingredient frame <NUM>, a housing <NUM> having at least one pump (<NUM>, <NUM>) (See <FIG>), a transfer set <NUM> (See <FIG>) that is selectively connectable to the housing <NUM> and that includes a manifold <NUM> attached to a plurality of micro input lines <NUM>, macro lines <NUM>, a controller connection <NUM>, a controller <NUM>, and a discharge tray <NUM> in which a final container, such as IV fluid bag <NUM>, can rest while connected to an output line(s) of the transfer set <NUM>. The transfer set <NUM> is intended to be a sterile, disposable item. In particular, the transfer set <NUM> can be configured to create or compound many different mixtures or prescriptions into appropriate receiving bags <NUM> for a predetermined time or predetermined volume limit. Once the transfer set <NUM> reaches its predetermined time and/or volume limit, the set <NUM> can be disposed of and replaced by a new transfer set <NUM>. In other words, the transfer set <NUM> is a pharmacy tool that is to be used for a full compounding campaign, for example, for a 24hour compounding run in which prescriptions for multiple patients are filled during that time period. Before beginning a given compounding procedure, the operator loads the various components of the transfer set <NUM> to the housing <NUM> of the compounding device <NUM>.

As shown in <FIG>, the transfer set <NUM> (See <FIG>) can be connected (or connectable) between the at least one input container (such as micro container(s) 4a and/or macro container(s) 4b) and the output container (such as an IV fluid bag <NUM>) via a plurality of lines (for example, micro input line(s) <NUM> and/or macro line(s) <NUM>). The transfer set <NUM> can include a plurality of micro and macro lines <NUM>, <NUM> extending therethrough, a manifold <NUM>, a strain relief clip <NUM>, a union junction <NUM> and an output line <NUM>. The micro and macro lines <NUM>, <NUM> run through at least one manifold <NUM> such that fluids from each of the separate supply containers 4a, 4b can be at least partially mixed in the manifold <NUM> prior to further mixing at junction <NUM> located downstream of pump <NUM>. The transfer set <NUM> is connectable to the main housing <NUM> of the system <NUM> and provides the connection between the input supply container(s) 4a, 4b and the output container. The housing <NUM> provides (among other features) pumping and control functionality to safely and efficiently select and deliver exact quantities of various fluids from containers 4a, 4b through the transfer set <NUM> to the output container. The manifold <NUM> can include two separate flow paths such that compounding can continue along a first flow path while the second flow path is interrupted.

The transfer set <NUM> macro lines <NUM> and micro lines <NUM> are all attached to specific inlet tubing ports (i.e., 20a and 20b) of the manifold <NUM>. The free or upstream ends of these lines are each uniquely marked with a permanent identification tag <NUM>. In this exemplary embodiment, the identification tag <NUM> is a bar coded flag or sticker. The identification tag <NUM> provides one-to-one traceability and corresponds to a specific instance of the inlet tubing port (20a or 20b) to which it is attached. The source containers 4a and 4b possess unique data identifying the type and kind of fluids contained therein. This data can also be formatted in bar code format and placed onto tag <NUM>. During use, the attached source containers (i.e., 4a and 4b) can be linked in the controlling software to the specific lines <NUM> or <NUM> by linking the source container data on the bar code format located on tag <NUM> to the bar code (or other identification information) located on the attached line identification tag <NUM>. Once connected, correlated and linked in this way, when the compounding device requires the specific ingredient, the software links established above determines which valve actuator 102a' or 102b' must be turned in order to introduce the required or intended source fluid into the compounded receiving bag <NUM>.

Connection of the transfer set <NUM> to the main housing <NUM> can be initiated by connecting the manifold <NUM> to the housing <NUM>. The manifold <NUM> can include a plurality of ports, such as micro input line port(s) 20a and/or macro input line port(s) 20b. The lines of the transfer set <NUM> can include a plurality of lines, such as micro lines <NUM> and/or macro lines <NUM> and/or combination micro/macro line(s) referred to as flex line(s). The plurality of lines can correspondingly connect to the above-referenced micro container(s) 4a and/or macro container(s) 4b at an input end of respective micro and macro line(s) <NUM>, <NUM>. An output end of each of the micro and macro line(s) <NUM>, <NUM> can be connected to the manifold <NUM>. The manifold <NUM> can be selectively connected to the housing <NUM> such that at least one valve 21a, 21b located in the manifold <NUM> can be aligned with a valve actuator 102a' and 102b' that can be incorporated in a stepper motor 102a, 102b located in the housing <NUM> (which will be described in more detail below).

In this exemplary embodiment, as shown in <FIG>, when installing the transfer set <NUM> onto housing <NUM>, the manifold <NUM> is connected to a top left side of housing <NUM> within a shallow tray indent 10c in the upper surface of the housing <NUM>. The shallow tray 10c allows spilled fluids or leaks to run off the pump housing <NUM> in order to prevent ingress of the fluids to the internal electronics and mechanisms of the compounding system <NUM>. In <FIG>, transfer set <NUM> and manifold <NUM> are not yet in position and are located above the housing <NUM> as if a user is starting the process of placing the transfer set <NUM> onto the housing <NUM> and preparing for use of the compounding system <NUM>. The transfer set <NUM> includes a manifold <NUM> that has two distinct channels: a first channel 24a that connects to a plurality of micro lines <NUM> and/or macro lines <NUM>, and a second channel 24b that connects to a plurality of macro lines <NUM>. Of course, in other embodiments the first and second channels could each be connected solely to micro, macro, flex, or other types of lines, respectively, or could be connected to combinations of micro, macro, or other types of lines. The first channel 24a and the second channel 24b are located in the manifold <NUM> and can be completely separate from each other (i.e., in fluid isolation from each other), such that no fluid from the first channel 24a mixes with fluid from the second channel 24b. The channel is considered that portion or area in the manifold through which fluid can flow. In this embodiment, a micro outlet 25a and a macro outlet 25b can be located on a downstream side of manifold <NUM> and connected to micro line <NUM> and macro line <NUM>, respectively. It should be noted that the lines downstream of the manifold (e.g., outlet lines, or micro line <NUM> and macro line <NUM>) can incorporate different tubing as compared to the inlet lines <NUM>, <NUM> that supply fluid to the manifold <NUM>. For example, the inlet lines can include tubing made of more or less rigid material as compared to the outlet lines, and can also include tubing made with larger or smaller diameter openings, or made of larger or smaller side wall thicknesses. In addition, the color of the inlet lines can be different from the color of the outlet lines, and the lines can also have different surface textures either inside or outside of the tubing. For example, the texture on the inside could be configured to promote or prevent turbulence, depending on the application and location of the line.

A sensor structure <NUM> can be located in the manifold (See <FIG>) and is configured to trip a sensor <NUM> (See <FIG>) located in the housing <NUM> that tells the system that the manifold <NUM> is in a correct/operational position. Alternatively, the sensor <NUM> can be configured to confirm the presence and gross positional information for the manifold <NUM>, but not necessarily configured to confirm that the position is fully operational. The sensor structure <NUM> can include a magnet <NUM> that goes into a housing <NUM> and provides a signal to (or actuates) the sensor <NUM> in the housing <NUM> which indicates that manifold <NUM> and transfer set <NUM> are properly (i.e., securely) in place (See <FIG>). Software used with the system can be configured such that the compounder <NUM> will not operate/function when sensor <NUM> does not sense or is not actuated by the magnet <NUM> (i.e., when the manifold <NUM> is not in proper position with respect to the housing <NUM>). After the manifold <NUM> is secured to the housing by clips 27a, 27b located on opposing ends of the manifold <NUM> (See <FIG>), a strain relief clip <NUM> can be seated onto the housing. The strain relief clip can be pre-assembled and attached to both the micro line <NUM> and macro line <NUM>. When installed, the strain relief can be placed to the right and immediately adjacent a sensor bridge 10e that forms a right wall of the shallow manifold tray indent 10c in which the manifold <NUM> is seated. The strain relief clip <NUM> can be pre-assembled to the transfer set <NUM> to ensure ease of use by the end user.

As shown in <FIG>, once the manifold <NUM> is attached to the housing <NUM> and the strain relief clip <NUM> is in place, the sensor bridge cover 10f can be closed over the sensor bridge 10e in order to protect the sensors and strain relief clip <NUM> from inadvertent contact and/or contamination from dust, liquids or other contaminants. The sensor bridge 10e can include a sensor or sensors (for example, an ultrasonic sensor, photo sensor, or other sensor) acting as a bubble detector and/or occlusion detector.

<FIG> shows an exemplary next step of installing the transfer set <NUM>, which includes connecting the union junction <NUM> to the housing by snapping clip locks 60f (see <FIG>) located on the junction <NUM> to mating locks formed on an upper surface of the housing <NUM> and to the right of the pump <NUM>. The output line <NUM> can be set within an output guide <NUM> (See <FIG>) formed in an outer wall that defines a second shallow pump tray indent 10d in the upper surface of the housing in which the pump <NUM> is located.

As shown in <FIG>, once the junction <NUM> and output line <NUM> are in place, the micro line <NUM> and macro line <NUM> can be seated within the peristaltic pump <NUM>. Alternatively, the union junction <NUM> can also be snapped into place after installing the pump tubing around each rotor <NUM>, <NUM>. In particular, micro line <NUM> can be placed about the outer periphery of first rotor <NUM> and macro line <NUM> can be placed about the outer periphery of second rotor <NUM>. In this position, the micro line <NUM> will be located between the first/micro rotor <NUM> and the first/micro platen 43a, and the macro line <NUM> will be located between the second/macro rotor <NUM> and the second/macro platen 43b.

<FIG> shows an exemplary next step for connecting the transfer set <NUM> to the housing <NUM>, which includes rotating the first/micro platen lock 44a clockwise to lock the platen 43a at its closed position relative to the first rotor <NUM>, and rotating the second/macro platen lock 44b counter-clockwise to lock the second platen 43b at its closed position relative to the second rotor <NUM>. In this position, when the rotors <NUM> and <NUM> are actuated and when any one of the valves 21a, 21b are rotated to the open position, each of the rotors will draw fluid(s) through respective lines <NUM>, <NUM> through peristaltic forces/actions. If one of the valves 21a or 21b is not opened and the pump rotor operates, the peristaltic forces will create a vacuum between the manifold channels 24a, 24b inside the micro lines <NUM> or macro lines <NUM> between the manifold <NUM> and the pump rotors <NUM>, <NUM> possibly resulting in an occlusion of the affected line. The occlusion will be detected as the wall of the micro lines <NUM> and macro lines <NUM> will partially collapse and this will be measured by the occlusion sensor within the sensor bridge 10e. The occlusion sensor 33o can be an optical sensor, a force based sensor, pressure sensor, an ultrasonic sensor or other known sensor for determining whether an occlusion has occurred in the line. In another embodiment, an occlusion sensor 33o and a bubble sensor 33b can be incorporated into the sensor bridge 10e. Alternatively, a combined sensor 33o/b or sensors 33o, 33b can be incorporated into the strain relief <NUM>, or at other locations along the system <NUM>, and can be integrated into the strain relief <NUM> or bridge 10e or can be separate and independent structures that are attached to the system <NUM>.

<FIG> shows an exemplary final step in the setup of the system <NUM>, in which the pump cover <NUM> is closed over the pump <NUM> to protect the pump <NUM> from contact with other devices/structures/persons and to protect the pump <NUM> and associated lines <NUM>, <NUM> from contamination from dust, liquids, or other contaminants. Each of the sensor cover 10f and pump cover <NUM> can include a magnet or other type of sensor or locking mechanism to ensure the covers are in place during operation of the system <NUM>.

Once the transfer set <NUM> is correctly connected to the housing <NUM>, input/storage containers 4a, 4b, and receiving bag <NUM>, and the covers 10f and <NUM> are closed, calibration of the system <NUM> and then processing and compounding of various fluids can take place.

<FIG> depicts an exemplary embodiment of a platen lock 44a. The platen lock 44a can be configured to rotate about a rotational axis and cause a cam <NUM> to come into resilient contact with the platen 43a. The cam <NUM> can include a biasing member, such as, for example, a spring <NUM>, including, but not limited to, a plate spring, coil spring, or other type of spring to cause the cam <NUM> to keep in constant contact with and apply a preset and constant force to the platen 43a, which in turn keeps a constant or preset force on the micro line <NUM> located between the platen and the rotor <NUM> to ensure accurate and predictable volumetric output by the pump <NUM> over the life of the transfer set. The spring <NUM> can be an important factor in the wear of the tubing lines during compounding, which can also impact the output of the pump <NUM>.

Accuracy can also be a function of pump tubing inner diameter, tubing wall thickness, and the spacing between rollers and platen. Accuracy is also affected by the speed of rotation, but both motors can have the same accuracy.

The platen lock 44a can have a streamlined appearance, being configured substantially as a simple, L-shaped structure with an overhang upper extension <NUM> and a rotational lower extension <NUM>. The lower extension having a longitudinal axis about which the platen lock 44a rotates. The platen lock 44a can be made from aluminum or other rigid material such as plastics, ceramics and/or other metals or alloys. The simple structure provides a user a sense of efficiency in the nature of operation of the platen lock structure 44a. The lower extension <NUM> can be configured with an opening to slide onto and attach to rotational post <NUM> extending from/within the housing <NUM>. The platen lock 44a can lock onto the post <NUM> via a simple friction fit, a spline type relationship between the post <NUM> and the opening in the lower extension <NUM>, or other structural configuration. In an alternate embodiment, a set screw structure <NUM> can be provided in the lower extension <NUM> for quick connection to the rotational post <NUM> that extends from the housing <NUM> of the compounding system <NUM>. In the embodiment depicted in <FIG>, a set screw <NUM> can be used to set the preload on the spring <NUM> that is contained inside the platen lock 44a, 44b. This spring <NUM> applies force on the platen 43a, 43b and ultimately squeezes the platen 43a, 43b against the respective rotor <NUM>, <NUM>. A magnetic lock structure <NUM> and <NUM> can also (or alternative to the screw structure <NUM>) be provided and can have multiple functions, including: locking the platen lock 44a to the housing <NUM> to prevent removal of the platen lock 44a from the housing <NUM> until the magnetic locks <NUM> and <NUM> are released. The location of platen lock 44a with respect to platen 43a can be achieved by a detent position on the backside of the platen 43a. As the platen lock 44a is rotated against the platen 43a towards the lock position, the cam <NUM> follows a profile on the back of the platen which includes a raised feature to compress the cam <NUM>, which the user has to rotate past to reach the final lock position. The action of the cam over this feature provides feedback to the user that the lock point has been reached, and mechanically maintains this lock position due to the cam sitting in a cavity feature. Continued rotation past the desired lock point can be prevented by providing hard stop geometry in the platen profile such that the cam cannot get past the hard stop geometry. The location of the cam <NUM> when the platen lock 44a is in this lock position, is where sensor 2904a is tripped via a magnet <NUM> embedded in the bottom of cam <NUM>. The coupling of lock arm 44a to the post <NUM> is achieved via a pair of magnets, the first <NUM> embedded in the top of post <NUM>, the second <NUM> at the end of the receiving bore in the lower extension <NUM> of the lock arm 44a.

Another benefit of this exemplary embodiment of the system <NUM> is that the configuration allows the operator to easily remove the platens 43a, 43b and platen lock components 44a, 44b from the pump housing for cleaning without the use of tools. Both platens 43a, 43b can be removed by simply pulling them upward and away from the pump housing surface 10d.

In addition, both rotors <NUM>, <NUM> can be removed without tools by simply unscrewing thumb screws that can be provided at a center / rotational axis of the rotors <NUM>, <NUM>. Because the rotors <NUM>, <NUM> can be interchangeable, their life can be extended by swapping their positions after cleaning, e.g., macro to micro and micro to macro.

The pump <NUM> can include rotors <NUM>, <NUM> that are each mounted upon and separately rotated by a respective stepper motor <NUM>, <NUM> (See <FIG>). Each of the stepper motors <NUM>, <NUM> can have a preset microsteps per revolution value that is relatively high (for example, on the order of <NUM><NUM> greater than the microsteps per revolution value for the stepper motors 102a, 102b used to rotate valves 21a, 21b located in manifold <NUM>, as described in more detail below). The high value of microsteps per revolution for the stepper motors <NUM>, <NUM> allows for greater accuracy or precision in fluid delivery for the system <NUM>. Each of the stepper motors <NUM>, <NUM> can be connected to controller <NUM> and can be separately, sequentially, serially, concurrently or otherwise controlled to cause each of the rotors <NUM>, <NUM> to rotate a known and predetermined amount and possibly at a predetermined speed such that a highly accurate amount and timing of material flow through the compounding device can be achieved. In addition, steppers <NUM>, <NUM> can be provided with absolute encoders that are in communication with controller <NUM> to provide explicit positioning control of the steppers <NUM>, <NUM>.

The rotors <NUM>, <NUM> can be substantially identical to each other such that they can be interchanged. For example, in one embodiment, the macro rotor <NUM> can be configured to rotate more than the micro rotor <NUM> and will thus be subject to higher wear. Thus, at some point during a break in operation of the compounding system <NUM>, the macro rotor <NUM> can be interchanged with the micro rotor <NUM> such that the rotor <NUM> will act as the macro rotor and be subject to the heightened wear for a time period. In this manner, the life of both rotors <NUM>, <NUM> can be extended.

The cam <NUM> and the spring <NUM> can also be configured to provide a known force to the platen 43a when the platen lock 44a is in a certain rotational position such that the platen lock 44a is effectively locked in place due to both resilient forces and frictional forces that occur when at the certain position relative to the platen 43a. In other words, once the platen lock 44a passes a predetermined rotational position, resilient force acting on the platen lock 44a by the platen 43a tends to cause the platen lock to continue its clockwise rotation. A sensor, such as a magnet <NUM>, can be provided in the platen lock 44a and configured to trip a corresponding sensor 2904a in the housing <NUM> that tells the system the platen lock 44a is in the correct position. However, if there is a rotational stop located in either the post in the housing or the lower extension <NUM>, the platen lock 44a will be unable to rotate further in the clockwise rotational direction and will simply maintain the above-referenced known resilient force (due to cam <NUM> and cam spring <NUM>) with the resilient force also acting to prevent release of (counterclockwise rotation of) the platen lock 44a. Unlocking the platen lock 44a from the platen 43a in this case would simply require the operator to overcome the resilient and frictional forces of the cam in the detent position tending to hold the structures in place. It should also be noted that the platen lock 44b and platen 43b can be configured in a similar manner as described above with respect to the platen lock 44a and platen 43a, except that locking would occur in a counterclockwise rotational motion.

<FIG> and <FIG> show a portion of an exemplary transfer set <NUM> that includes a manifold <NUM> connected via micro line <NUM> and macro line <NUM> to a strain relief clip <NUM>. Micro line <NUM> and macro line <NUM> extend past the strain relief clip <NUM> and eventually combine or merge at the union junction <NUM>, resulting in a single outlet line <NUM> for the transfer set <NUM>. The macro lines <NUM> can be portions of the same continuous tubing structure. By contrast, in this example, micro lines <NUM> are separate structures joined together by shunt <NUM>. The shunt <NUM> can be made from a material that is harder than the micro lines <NUM>. For example, the micro lines <NUM> can be made from silicone tubing while the shunt <NUM> can be made from a relatively more rigid PVC material. The shunt <NUM> provides extra rigidity such that the strain relief clip <NUM> can connect securely thereto without causing the inner diameter of the shunt <NUM> to be squeezed or otherwise reduced. One or more collars 33d can be provided on the shunt <NUM> to lock to the clip <NUM> and prevent the shunt <NUM> from moving along a longitudinal axis of the micro lines <NUM>. Additional collars are contemplated so that manufacturing can be easier with respect to consistently locating/ assembling of the manifold set structures. By contrast, the macro line <NUM> can be sufficiently large enough in diameter and thickness such that its inner diameter is not squeezed or reduced when the clip <NUM> is attached thereto. Thus, when the strain relief clip <NUM> is attached to the micro lines <NUM> and macro line <NUM>, the clip <NUM> does not significantly change the inner diameter characteristics for the lines while preventing forces acting along the longitudinal axes of the lines from being transmitted past the clip <NUM>. Thus, when the micro line <NUM> and macro line <NUM> are connected about a respective rotor <NUM>, <NUM> of the peristaltic pump <NUM>, the rotary forces acting on the lines do not translate along the micro and macro input lines back towards the manifold <NUM> and the bubble and occlusion sensors. The strain relief clip <NUM> acts as a damper to minimize transmission of linear forces and vibrations from the pump <NUM> to the manifold <NUM>. Minimizing these forces and vibrations optimizes the functionality of the bubble and occlusion sensors which would otherwise be impacted by changes in tubing tension as the tubing is pulled by the peristaltic action of the pump. Similarly, the strain relief provides a fixed position on the set <NUM> relative to the manifold <NUM> to facilitate installation of the tubing or line segments through the occlusion and bubble sensors 33o, 33b, 33o/b and maintains a repeatable tension on these line segments.

The strain relief clip <NUM> can be of various shapes, and in the embodiment shown in <FIG> the clip <NUM> is configured as a two piece clam shell type design in which an upper portion 33a can be attached to a lower portion 33b by clips 33i that are integrally formed at locations about a perimeter of each portion 33a and 33b, and mate with snap latch receptacles 33j in an opposing portion 33a, 33b. Throughways 33c can be formed as half cylindrical cutouts in the upper portion 33a and lower portion 33b. A guide sleeve <NUM> can be provided at a corner of one of the clam shell portions 33a, 33b to guide the opposing claim shell portion 33a, 33b into engagement when coupling the clam shell portions 33a, 33b. The micro line <NUM> and macro line <NUM> can pass through these throughways 33c and be locked to the strain relief clip <NUM> by a series of ridges 33r that connect to mating ridge <NUM> in the shunt <NUM> and/or to the macro line <NUM> itself. It is possible that the strain relief parts 33a and 33b are in fact identical so that the above described process and configuration is possible with the use of two instances of the same component.

<FIG> show various cross-sections of the exemplary manifold <NUM> of <FIG> without valve structures located therein for clarity. The cross section shown in <FIG> depicts two sets of ports: two macro ports 20b and two flex ports 20bf that are each cylindrical in shape and are in fluid communication with a valve housing 20bh and 20bfh, respectively, located immediately underneath the ports 20b and 20bf. The ports 20b and 20bf are configured such that a macro line <NUM> can be slid into the inner periphery of the upward and outward facing cylindrical opening in the ports 20b and 20bf for attachment thereto. Thus, the ports 20b and 20bf can be connected to various macro source containers 4b via the lines <NUM> attached to the ports 20b and 20bf. A valve 21b, 21a (to be described in more detail below) can be located within the valve housing 20bh, 20bfh, respectively, located beneath the ports 20b, 20bf. When the valve 21b, 21a is located in the housing 20bh, 20bfh, the valve 21b, 21a selectively connects the fluid located in line <NUM> with the fluid located in channel 24b, 24a of the manifold depending on the valve's rotational position within the housing 20bh, 20bfh.

The manifold described above can, in the exemplary embodiment, be formed (e.g., molded) as one unitary structure <NUM> including all of the features 20a, 20b, 20bf, 20ah, 20bh, 20bfh, 24a, 24b, 25b, <NUM>, 27a, 27b, and <NUM>. Also, it is possible to join any or all separate structures (components) 20a, 20b, 20bf, 20ah, 20bh, 20bfh, 24a, 24b, 25b, <NUM>, 27a, 27b, and <NUM> in any combination into a manifold assembly <NUM> to achieve the same purpose.

<FIG> show a bottom view of the manifold <NUM>, an exploded view, and an assembled view, respectively. The manifold <NUM> includes an array of macro ports 20b located in a linear fashion along either side of second channel 24b. The first channel 24a includes both flex ports 20bf and micro ports 20a located along the length thereof and provides fluid communication therebetween. Thus, the first channel 24a can be connected to both a macro flex line <NUM> and a micro line <NUM>. In this embodiment, the flex line is configured as shown in <FIG> as a first macro line <NUM> that is joined at a junction <NUM> to two outgoing macro lines <NUM> to allow fluid from macro container 4b to be supplied to both the first channel 24a and second channel 24b. In other words, a jumper branch connection in a macro line <NUM> can be provided such that the macro line <NUM> branches in two directions after leaving the macro storage container 4b, and can be connected to both the second channel 24b and the first channel 24a. The flex line conducts the same fluid/solution (e.g., nutritional ingredient) from container 4b to both channels 24a and 24b of the manifold <NUM> after passing through the valves 21bf and 21b, respectively. This facilitates the option of a singular or larger source container 4b being used for purposes of flushing/clearing the channels 24a and 24b as opposed to two separate containers 4b, wherein one container is connected to channel 24a and a separate other container is connected to channel 24b. A plurality of flex lines can be used since multiple types of flushing ingredients may be required during a compounding campaign depending on the varying clinical needs of the intended final contents of sequentially filled receiving containers (e.g. final bags <NUM>). It should be noted that in this embodiment flex lines are terminated at flex ports 20bf (See <FIG>) farthest along the channels 24a and 24b from the outlets 25a and 25b, thereby allowing the entire channels 24a and 24b to be flushed with the flushing ingredient. In this embodiment, the micro line <NUM> is not branched after leaving the micro storage container 4a, and therefore, there are no micro ports 20a that communicate with the second channel 24b. It is contemplated that an embodiment of the disclosed subject matter could include a manifold configured with valves adapted to allow micro lines to be attached to both the first and second channels 24a and 24b. Flex lines are designed to be used for any ingredient which may be requested across a wide range of volumes among different patient prescriptions. Hence, for some prescriptions where they are requested in small volumes, they can be delivered by the micro pump. Similarly, for prescriptions where they are requested in large volumes, they can be delivered by the macro pump. The y-connection fluid path of the flex line gives the ingredient access to both fluid paths (micro and macro) therefore the system can decide which pump to use to deliver that ingredient appropriately based on the requested volume.

In <FIG>, the valves 21a, 21b and filler <NUM> are disassembled to better show their relationship with the macro valve housing 20bh, micro valve housing 20ah, and first channel 24a in which each of these structures resides when assembled and ready for use. As can be seen, each of the valves 21a and 21b include a keyway 21a4 and 21b4, respectively, that allows for positive attachment to an actuator member 102a' and 102b' that extends from a manifold indent/surface 10c in the housing <NUM> of the compounding device.

The operational valve structures are in fact combinations of the rotating members (valves 21a and 21b) and the inner diameter (ID) of the socket in the manifold (20ah and 20bh) in which the valves 21a, 21b are located. The configuration of the operational valve structures was intended to create a more moldable elastomeric valve in which, under static fluid conditions, gravity based movement of fluids (like the motion caused by fluids of differing densities or different specific gravities settling or rising when the valve is left open) can be prevented or limited.

The actuator member is controlled by at least one stepper motor 102a, 102b such that rotation of the valves 21a and 21b can be precise. In one embodiment, the stepper motor 102a for the micro valves 21a can be of higher precision than the stepper motor 102b for the macro valves 21b (See <FIG>). Higher precision stepper motors can be used to provide the positional accuracy of the micro valves 21a due to the inherent flexibility of the micro valves 21a. For example, a stepper that has a preset value of about <NUM> microsteps per revolution can be used (which preset value can be on the order of <NUM><NUM> less than the microsteps per revolution value for the pump). Accuracy of the valves 21a, 21b (i.e., precise movement of the valves 21a, 21b) can be further controlled through the use of a tall gear box, which would result in large input rotations for the stepper motors 102a, 102b providing for small movement of each of the valves 21a, 21b, respectively. The flexibility of material that makes up each of the valves 21a, 21b can be configured or selected to enhance or provide improved sealing surfaces which withstand pressure differentials without leaking. Given this torsional flexibility and considering the friction opposing rotation of the micro valve 21a, it follows that during rotation, the upper features of the micro valve 21a, i.e., those opposite the drive slots 21a4, angularly lag behind the lower features of the micro valve 21a. Thus, in order to properly place the fluid opening between the micro valve 21a and the first channel 24a, the higher precision stepper motors first rotate the micro valve 21a so that the top of the micro valve 21a is properly positioned, and then reverse direction to bring the lower features also into proper position and therefore straightening the micro valve 21a. The same action returns the micro valve 21a to the closed position. The rotation of the steppers 102a and therefore the actuators 102a' and the micro valve 21a, can be clockwise, counter-clockwise, or any combination of these directions. Because, the micro valves 21a typically control the smaller volume ingredients, the volume should be measured and distributed with relatively higher accuracy as compared to that of the macro valves 21b which typically distribute large volume ingredients in which high accuracy is easier to achieve. However, it should be understood that accuracy of delivery is not necessarily a direct function of valve operation. As long as the valves 21a, 21b are properly opened and closed, the pumps <NUM>, <NUM> can be used to provide accuracy of amount and control of fluid delivery.

In operation, the micro valves 21a and macro valves 21b can be described as being overdriven by the stepper motors past the 'open' position since the valves are flexible and the top of the valve lags behind the bottom of the valve when rotated. Thus, to properly open the valve, the bottom of the valve is overdriven from the target angular position. Once the top has achieved a proper location, the stepper reverses and brings the bottom of the valve into proper position. This operation effectively twists and then straightens the valve, and occurs in both the opening and closing process for the valves 21a, 21b.

<FIG> and <FIG> show the valves 21a, 21b and filler <NUM> in place in the manifold <NUM>. The filler <NUM> takes up volume within the first channel 24a such that the cross sectional area of the first channel 24a taken normal to a longitudinal axis of the channel 24a is smaller than the cross sectional area of the second channel 24b taken normal to a longitudinal axis of the channel 24b. Thus, the inner periphery of the first channel 24a and second channel 24b can be similarly shaped, allowing for certain architectural benefits in placement of the valves 21a, 21b and in fluid flow geometry of the channels 24a, 24b. The filler <NUM> can include a filler rod <NUM> that includes a plurality of spacers <NUM> located along the rod <NUM> so as to keep the rod <NUM> centered within the channel 24a. A clip lock <NUM> can be provided at a proximal location of the rod <NUM> and configured to lock with a mating clip lock indent in the manifold <NUM>. In particular, a flexible tab 203a can be located on the lock <NUM> and configured to mate and lock with opening 203b in manifold <NUM> (See <FIG>). A sealing member <NUM>, such as an O-ring <NUM>, as shown in <FIG>, can seal the filler <NUM> in the socket <NUM> to prevent fluid such as air or liquids from leaking into or out of the channel 24a via the socket <NUM> when the filler <NUM> is located therein. The sealing member <NUM> can be located in an indent or receiving groove 204a on the rod <NUM> to lock the sealing member <NUM> in place with respect to the filler <NUM>. One function of the filler <NUM> is to reduce common volume in channel 24a, which reduces priming volume and flushing volume. Because the micro pump only achieves limited flowrates, the large cross section of channel 24a without the filler would be difficult to be flushed of residuals.

Placement of the filler <NUM> in the channel 24a has the added benefit of increasing (or otherwise controlling and directing) turbulence within the channel 24a, and thus increases maximum fluid velocity within the channel 24a, permitting faster and more thorough flushing of residual fluids in the channel 24a to output 25a. The filler <NUM> can be conveniently loaded into the manifold via socket <NUM> during the time the manifold assembly <NUM> is being manufactured. The filler <NUM> geometry, particularly at the downstream end, is designed to promote flushing and to avoid areas where residual fluid can hide out and not flush properly.

Each of the micro and macro valves 21a and 21b can be configured as a rotational type valve that, when rotated a set amount, permits a corresponding or known amount of fluid to bypass the valve. In one embodiment, the valves 21a, 21b can be configured such that rotation of each of the valves does not move fluid, and only opens/closes a fluid path. The amount of fluid that bypasses the valve can, however, be ultimately determined by the pump speed, size and in conjunction with the tubing size when using a peristaltic pump. The valves can be configured to simply open or close the fluid lines. <FIG> shows a macro valve 21b that includes an inlet 21b1 at a top of the structure and an outlet 21b3 at a side wall of the structure. Thus, fluid enters the top of the valve 21b along a rotational axis of the valve 21b, and exits a side of the valve 21b in a direction substantially normal to the rotational axis of the valve 21b. Rotation of the valve 21b is accomplished by connection to a stepper motor 102b via actuator connection slot 21b4 located in a bottom surface of the valve 21b. The slot 21b4 acts as a keyway for a corresponding projection 102b' extending from the top of the stepper motor 102b. When the stepper motor 102b turns the projection 102b' a preset amount, the valve 21b is also caused to turn the same amount due to the connection between the projection 102b' and the keyway or slot 21b4. When the valve 21b is located in an open position or a semi open position, fluid can travel from the inlet 21b1 down through a center of the valve 21b until it passes wall 21b2, which can be configured as a gravity wall, or P-Trap, or similar structure. After passing the wall 21b2, the fluid then changes directions by approximately <NUM> degrees and moves up and over the outlet wall in the manifold <NUM> to be distributed into the second channel 24b. The wall 21b2 and geometry and configuration of surrounding manifold walls prevents fluid from inadvertent and uncontrolled mixing between lines <NUM>/<NUM> and the common volume of channel 24a on the micro side and between lines <NUM> and the common volume of channel 24b on the macro side when <NUM>) the valve is open, <NUM>) the fluid is static (i.e., pump rotors <NUM> and <NUM> are not moving), and <NUM>) there exists a differential in specific gravity between the respective fluids in the input lines and in the channels. The motivator for this backflow is specific gravity differences between the ingredient fluid and the fluid in the channel. This wall 21b2 is a technical feature of the valve that mechanically prevents this backflow from occurring without additional control mitigations, and requires no additional software/valve controls to limit the effect of this backflow tendency because the wall structure physically stops or prevents backflow from happening. Thus, the walls 21b2 and surrounding geometry of the valve housing 21bh prevents contamination of the ingredients in the supply lines and storage containers 4b and prevents uncontrollable flow/mixing into the channels 24a and 24b of the manifold <NUM> due to, for example, differences in specific gravity of the solutions or fluids running through the valves. The output of the micro and macro valves 21a, 21b (with respect to each respective opening into the common channels 24a, 24b located in manifold <NUM>, shown in <FIG>) is above the above-described "P-trap" thus not allowing flow that might otherwise enter into the manifold <NUM> due to specific gravity differences. Thus, the valves 21a, 21b work with the structure of the manifold <NUM> in this embodiment to form the specific gravity "P-trap" structures.

Although <FIG> show a macro valve 21b, the micro valve 21a can be configured and will operate in the same manner, albeit using smaller dimensions.

The two motors that drive each of the rotors <NUM>, <NUM> can be the same, and similarly the rotors <NUM>, <NUM> can be identical. The tubing in each channel can be different, and the platen positions can be different because of the difference in the diameter and wall thickness of the tube sections.

<FIG> shows a perspective view of the union junction <NUM>. The union junction <NUM> is configured to retain and/or receive a tubing structure that includes a micro input line inlet port 60a, a macro input line inlet port 60b, a union junction line <NUM> and an outlet port <NUM>. The micro input line inlet port 60a is configured to receive the micro line <NUM> which carries fluid from the micro channel, which can include fluid from one or both the micro fluid containers and macro fluid containers that were described earlier. The macro input line inlet port 60b is configured to receive the macro line <NUM> which carries fluid from the macro fluid containers that were described earlier. The micro input line inlet port 60a and the macro input line inlet port 60b are both coupled to a junction line <NUM>. Thus, fluid flowing from the micro line <NUM> enters the micro input line inlet port 60a and flows through the junction line <NUM> and is combined with fluid received by the junction line <NUM> from the macro line <NUM> via the macro line inlet port 60b. In this manner, fluid from micro line <NUM> is combined with fluid from the macro line <NUM> for delivery to the receiving/final container (e.g., IV bag <NUM>). <FIG> also shows macro input line tie down 60c that maintains the macro input line inlet port 60b in place. A similar tie down 60c can be used to secure or maintain the micro input line inlet port 60a in place. The junction line <NUM> includes an outlet port <NUM> coupled to a combined fluid line <NUM>. As fluids from the micro line <NUM> and the macro line <NUM> combine in the junction line <NUM>, they flow through the outlet port <NUM> to the combined fluid line <NUM>. The fluid flows from the combined fluid line <NUM> to the final container or receiving bag filling station which is described in greater detail below. <FIG> also shows that the union junction <NUM> includes handles 60e which can be used for the placement and removal of the union junction <NUM> onto mating receptacles on the housing <NUM>. Locks, such as flexible spring locks 60f, can mate with receptacles on the housing <NUM> to further secure the junction <NUM> thereto.

<FIG> shows a bottom side perspective view of the union junction <NUM>. <FIG> shows that the union junction <NUM> includes a plurality of standoff ribs <NUM> and pin bosses <NUM> which are spaced apart from each other along an interior surface of the union junction <NUM>. The standoff ribs <NUM> and pin bosses <NUM> are configured to provide an insertion spacing stop to retain the junction <NUM> at a predetermined distance/height relative to the housing surface. The standoff ribs <NUM> and pin bosses <NUM> can also provide structural integrity for the tubing structures described above, including the micro input line inlet port 60a, the macro input line inlet port 60b, the junction line <NUM> and the outlet port <NUM> so that those structures are maintained in place even as fluids are passed therethrough.

<FIG> shows a top view of the union junction <NUM> with the tubing structures described above in place. As can be seen in <FIG>, the union junction line <NUM> receives fluid via the micro input line inlet port 60a and the macro input line inlet port 60b. The fluids mix in the union junction line <NUM> and are carried to the outlet port <NUM> for eventual delivery to the receiving bag <NUM>. As shown in the <FIG> and in this exemplary embodiment, the micro input line inlet port 60a joins the union junction line <NUM> in a direction perpendicular to a longitudinal direction of the union junction line <NUM>, while the macro input line inlet port 60b causes fluid to flow into the union junction line <NUM> in the same direction as the longitudinal axis of the union junction line <NUM>. In alternative embodiments, the micro input line inlet port 60a can join the union junction line <NUM> at any angle relative to the longitudinal direction of the union junction line <NUM> so as to optimize usability of loading onto the platform 10d and notch <NUM> and simultaneously ensure proper contact with pump rotors <NUM>, <NUM> and optimize flushability of the union junction <NUM>.

The tubing structure described above, including the micro line inlet port 60a, the macro line inlet port 60b, the union junction line <NUM> and the outlet port <NUM> can be formed, e.g., molded, into the union junction <NUM> so as to form a unitary structure. Alternately, the tubing structure can be formed as a separate unit that can be placed or snapped into the union junction <NUM> and retained in place using a mechanism such as the standoff ribs <NUM> and pin bosses <NUM> described above. In addition, it should be understood that the compounding device <NUM> can be configured without the presence of a union junction <NUM> as shown. Instead, the union structure can be the final container, such as the receiving bag <NUM> itself. For example, lines <NUM> and <NUM> can extend about rotors <NUM>, <NUM> and continue all the way to two separate ports in the receiving bag <NUM> such that mixing of materials from lines <NUM> and <NUM> occurs only at the receiving bag <NUM>. In this case, it may be beneficial, depending on the particular operating parameters, to secure lines <NUM> and <NUM> at locations downstream of the rotors <NUM>, <NUM> to ensure proper and efficient operation of the pump <NUM>.

<FIG> shows perspective view of the compounding system <NUM> in accordance with an exemplary embodiment. <FIG> shows housing <NUM> located adjacent a bag tray <NUM> for holding a receiving bag <NUM> during the filling process. A load cell <NUM> or other device, such as an analytical balance, can be integrated into the bag tray <NUM> to provide information relative to the weight and contents and to facilitate calibration as well as confirmation of operational functions for the compounding device <NUM>. Protective devices and/or software can be incorporated into the device to protect the load cell <NUM> or other measuring device from damage due to accidental overload or other mishaps. As shown in <FIG>, the bag tray <NUM> includes a bag tray receiving section <NUM> that accommodates the shape of the receiving bag <NUM>. The bag receiving section <NUM> can be formed as a generally indented surface within the surface of the bag tray <NUM>. The bag tray <NUM> also includes bag tray pins <NUM> which are formed on an upper section of the bag tray <NUM>. As shown in <FIG>, the bag tray pins <NUM> are formed perpendicular to the surface of the bag tray <NUM> so as to project in a direction away from the top surface of the bag tray <NUM>. The bag tray pins <NUM> are positioned to receive and hold a receiving bag <NUM> for filling. <FIG> also shows a bag tray clip <NUM> which is formed along an upper section of the bag tray <NUM>. The bag tray clip <NUM> can be configured to keep a known tubing artifact constant with respect to the fluid line(s) <NUM> connected to the receiving bag <NUM> (i.e., can be configured to dampen vibration or other force transmission to the bag <NUM> and/or load cell <NUM>). Depending on how the bag <NUM> is connected to the outlet of the transfer set, and how the tube is positioned, variances can occur. The clip <NUM> prevents these variances.

<FIG> shows a close up view the upper section of the bag tray <NUM> illustrating the placement of the bag tray pins <NUM> that are positioned to receive and retain a receiving bag <NUM> for filling. <FIG> also shows the bag tray clip <NUM> which is provided to secure the container input tubing, which includes the combined fluid line <NUM>. <FIG> shows a close up view of the upper section of the bag tray <NUM> including a receiving bag <NUM> placed in the bag tray <NUM>. The exemplary receiving bag <NUM> includes two openings <NUM> for receiving the bag tray pins <NUM>. Thus, when the bag tray pins <NUM> are placed through respective openings <NUM> of the receiving bag <NUM>, the receiving bag <NUM> is maintained in place for filling. <FIG> also shows a twist lock <NUM> formed on the end of the combined fluid line <NUM>. The twist lock <NUM> is configured to connect to and lock with a port <NUM> formed on a top surface of the receiving bag <NUM>. The twist lock <NUM> allows the combined fluid line <NUM> to be securely coupled to the receiving bag <NUM> so that the receiving bag <NUM> can be filled. The bag tray clip <NUM> can be configured to securely retain the port <NUM> and twist lock <NUM> that allows for quick placement, filling and removal of the receiving bag <NUM>. The clip <NUM> also secures the tubing to the bag tray to prevent unwanted artifacts in the load cell <NUM> measurement that could occur from excessive motion of the tubing segment that spans the gap between the bag tray and the pump module. This tubing motion could be caused by user interaction or pump vibration during compounding. Manual port <NUM> can be provided at the top of the receiving bag <NUM> such that a user can inject an ingredient that is either not included in the compounding system <NUM> or has run out and is required to complete the receiving bag <NUM>.

In similar fashion to the description above, a dual chamber bag may be filled using a slightly modified workflow, wherein the dual chamber bag keeps incompatible ingredients separate by two physical separated chambers that are kept separate from each other during compounding, but are combined just before infusion of the patient is started. All of the steps described above are followed for the 'primary' side of the receiving bag. Once complete on the primary side, the primary side port 1360a is disconnected from the twist lock <NUM>. The secondary bag port 1360b can then be connected to the twist lock <NUM> and the secondary chamber thus filled.

<FIG> is a rear partial perspective view of the compounding system <NUM> that shows an exemplary sensor array used in conjunction with the system. Sensors <NUM> can be configured to sense when the covers 10f and/or <NUM> are in place (See <FIG>). Alternatively, a reed switch sensor can be built into the combination sensor assembly to provide confirmation that 10f is closed. Sensors <NUM> can be magnetic, such that they serve two purposes: <NUM>) communication to a controller <NUM> information indicating that the covers 10f and/or <NUM> are in a closed/operational position; and <NUM>) securing, via magnetic force, the covers 10f and/or <NUM> in place in the closed/operational position. It should be understood that the sensors themselves may not provide enough force to provide a hold down function. Instead, a ferrous catch plate and lid magnet can be used in conjunction with the magnetic sensor. Sensors 2904a and 2904b can be configured to communicate to the controller <NUM> that the platen locks 44a and 44b, respectively, are in a closed/operational position. Sensor <NUM> can be provided in housing <NUM> and configured to communicate with the controller <NUM> information that indicates that the manifold <NUM> has been properly affixed to the housing <NUM> and is ready for operation.

Sensor <NUM> can be located adjacent a rear surface of the housing <NUM> and configured to communicate with the controller <NUM> information that places the compounding system <NUM> in a service or firmware/programming mode when a maintenance operator or technician activates this sensor (for example, by placing a magnet adjacent the sensor <NUM>). The location of the sensor <NUM> may be known only to service and technical maintenance personnel.

The exemplary compounding system <NUM> can also include a compounding control manager which resides in a central processing unit (e.g., controller <NUM>). The compounding control manager allows a clinician or other healthcare or compounding professional to enter, view, adjust and offload information pertaining to a given compounding protocol. In general, the compounding control manager is the program language that provides the operator with real time feedback and interaction with the compounding device through graphical user interface (GUI) elements. The GUI elements, created in a graphical format, display the various inputs and outputs generated by the compounding control manager and allow the user to input and adjust the information used by the compounding control manager to operate the compounding device. To develop the GUI elements, the compounding control manager can utilize certain third party, off-the-shelf components and tools. Once developed, the compounding control manager can reside as a standard software program on a memory device.

The controller <NUM> can include firmware that provides several adjustment algorithms or hardware solutions to control the accuracy of the pump <NUM>. For example, the pump output can be corrected for wear of the pump tubing lines <NUM>, <NUM> over the life of the transfer set or manifold <NUM>. This adjustment is applied as a function of the number of pump rotations experienced by each tubing line. The controller <NUM> can also include software or hardware such that pump output or "flow factor" can also be adjusted for the specific fluid being pumped. This "flow factor" can account for fluid viscosity, pump speed, line type, and source container/spike type. The controller <NUM> can also be configured to correct pump output for the rotational location of the pump rotor <NUM>, <NUM> rollers relative to the platens 43a, 43b. This adjustment can be significant for small volumes that are dispensed and which represent only a few rotations of the pump head or less. Note that absolute encoders can be included on both pump motors <NUM>, <NUM> (and valve steppers) to provide the firmware (e.g., controller <NUM>) with the information necessary to make the above-noted adjustment(s). The controller <NUM> can include a bubble detection algorithm that attempts to minimize nuisance alarms.

<FIG> are a walk-through of display screens generated by a representative embodiment of the compounding control manager, which demonstrate various features of the compounding control manager. After an initial start-up mode of software initialization, a main work area is created on a display device, which initially opens a log-in screen. The operator first identifies him or herself, either by using the bar code scanner to scan an operator badge number, or by entry of a badge number or other selected form of identification on the graphical touch screen entry pad. This identification procedure is required for logging-in and/or assessing the operator's level of security clearance. Desirably, a system administrator would have previously established a list of authorized users, against which the sign-in data is compared.

<FIG> depicts an interface that may be presented to a user after the user has logged in and been authenticated as an authorized user. <FIG> is a control panel that allows the user to indicate the type of transfer set to be used, select the number of stations to be used and select the source solution configuration template. The user may then be presented with the interface shown in <FIG>. The interface of <FIG> allows the user to scan a bar code located on a lid of a tray in which the transfer set <NUM> is provided. In this manner, the system knows the transfer set <NUM> that the user has chosen. The user can then remove the transfer set <NUM> from the packaging and install it. The process of installing the transfer set <NUM> includes opening the device doors and platens, placing and snapping the transfer set manifold <NUM> to the top of valve actuators 102a', 102b' and platform 10c and draping the leads of the transfer set over a rack that is disposed in the laminar flow hood.

After the user snaps down the manifold <NUM> onto the device, the user may then route the tubing through a bubble and occlusion sensor followed by closing the sensor lid. Next, the user can route the tubing around the pump rotors and secure union junction to the pump module. Each of the rotors can include a bottom flange or guide member that is configured to prevent the tubing from being installed too low or slipping or being pinched between the pump surface and the rotor. Finally, the user can close the platen locks and then close the pump door or cover. The user is also presented with the interface of <FIG> which includes a checklist of each of the tasks described above. Once each of the tasks is completed, the user can select "OK" to verify completion of the tasks. In this manner, the system ensures that the user has completed the transfer set installation before proceeding to the next step.

The user can then initiate calibration of the load cell <NUM> by selecting the "scale calibration button" shown in <FIG> shows a further interface that is presented to the user to ensure that the load cell <NUM> is properly calibrated. When the calibration is completed, the user can then select the "close" button.

The user then confirms the source solutions. <FIG> shows an interface that is presented to the user for confirming the source solutions. The user can select the button that reads "confirm solution. " At this point, the user can select the tubing lead (i.e., micro line <NUM> or macro line <NUM>) to be confirmed and can remove a protective cap that covers the lead. The user can then attach the appropriate lead. The user can then attach the source container to the tubing lead and hang the container on the rack or rail. The user is then presented with the interface of <FIG> whereby the user can scan the bar code flag <NUM> of the tubing lead for the solution to be confirmed. The user can then scan the source container bar code <NUM> for the solution attached to the tubing lead that is scanned. The lot number and expiration date bar can also be scanned (<FIG>).

After completing confirmation of the first container, the user can select the "next ingredient" button shown on the interface of <FIG>. This allows the user to repeat the steps of <FIG> above which allows confirmation of all of the source solutions.

Once the source solutions have been confirmed, the user can initiate the priming of the solutions. The user first attaches a receiving bag <NUM>, i.e., calibration container, to the load cell <NUM>. Then, after all of the solutions have been confirmed, the user taps the "setup and prime" tab shown in <FIG>. After priming is completed, the user can select the "next" button and repeat this process for all stations. The user can also initiate the manifold flush at this point. Next, the user can initiate a pump calibration sequence via the interface of <FIG>. The user can then follow steps <NUM>-<NUM> of <FIG> to calibrate the pump. These steps include confirming that that calibration final container is attached and marked "Not for Patient Use"; calibrate the macro pump; confirm that the macro pump is calibrated; calibrate the micro pump; and then confirm the micro pump calibration. The user can then remove and discard the calibration bag.

Next, the user can install the final container (e.g., receiving bag <NUM>). The user may be presented with the interface of <FIG> which allows the user to select the option of installing the final container. The user may then be presented with the interface of <FIG> which allows the user to select a single chamber or a dual chamber receiving bag. The user can then scan or enter the lot number and expiration date. The user can then attach the final container by removing the protective caps and attach the receiving bag <NUM> to the transfer set connector. The user can then install or otherwise attach the receiving bag <NUM> by using the hanging holes formed in the container to connect to the load cell pins and then attach the tubing inlet to the tubing clip.

At this stage, the system has been calibrated, the solutions to be dispensed have been verified and the receiving bag <NUM> has been installed and is ready to be filled. The user can manually program an order for the solutions to be dispensed using the interface shown in <FIG>. Alternatively, the user can scan in an order or select an order from a transaction pending buffer (TPB) manager or a. Utilizing the interface of <FIG>, the user can enter all of the solution volumes to be dispensed. Once the solution volumes have all been programmed, the user can select the "start" tab shown in <FIG>. As shown in <FIG>, if a solution requires a source container 4a or 4b change while compounding the next formulation, the station will display the solution requiring a change in yellow.

The controller <NUM> can be configured to review the prescription and to require the user to either change the sequence of the script or to add a buffer to avoid incompatibility issues in either of the common channels 24a, b (micro/macro). The pump <NUM> will control deliveries from each of the common channels by stopping one or more of the pumps <NUM> if the incompatible fluids would meet in the union connector <NUM> after the pumps <NUM>.

<FIG> shows a warning interface that is presented to the user when the software determines that the source solution container 4a or 4b has insufficient volume. The user can then replace the container or, if there is some solution remaining, a manual dispense can be performed. If the user chooses to perform a manual dispense, the user enters the estimated volume remaining using the interface of <FIG>.

In order to replace the solution, the user can remove the empty container 4a or 4b and place a new container on the tubing lead and hang. The user can then access the interface of <FIG> to scan the bar code flag of the tubing lead for the new solution to be confirmed. The user can then scan the source container bar code for the solution attached to the tubing lead that is scanned. The lot number and expiration date bar codes can also be scanned. The user can then select the "confirm" button to complete this step.

The user can then resume compounding via the interface of <FIG>. Once the order is complete, the user can select the appropriate disposition for the receiving bag <NUM> (i.e., complete filling; scrap bag, etc.). Finally, the user can select the "apply disposition button. " This completes the compounding process and the receiving bag <NUM> is ready for removal and can be used with a patient or other end user.

After all the required ingredients have been processed, the controller <NUM> will direct the compounder to use a universal ingredient (UI) to flush all of the ingredients out of the manifold <NUM> and output tubing and into final container (e.g., fluid bag <NUM>).

The fluid bag <NUM> resides on a gravimetric scale <NUM> that provides a final weight check back to the controller <NUM> to verify that all compounded solutions were added. However, if a manual add of a particular component is necessary or desired during operation, the final check by the controller <NUM> can be overridden. The load cell <NUM> can also be used to accomplish pump calibrations as well as in process calibrations, if desired.

The controller <NUM> can include hardware or software that performs calibration of the load cell <NUM> and pump <NUM>. For example, the system can be configured to allow up to <NUM> verification weights to ensure the load cell is within required accuracy. Pump calibration and in process calibrations ensure accuracy over the life of the disposable manifold <NUM>.

The controller <NUM> can also include a tube wear algorithm such that tubing wear is accounted for during the life of the manifold <NUM>. In other words, the timing and speed of both the valves and the pump motors can be changed over time to account for tubing wear such that a substantially equal volume and flow rate can be achieved by the device.

The controller <NUM> can also include software and/or hardware to track and possibly mark bags such that manual adds can be added to a particular bag after automatic compounding. Use of a separate (possibly networked) control panel at a manual add station will open the compounding event and allow the user to manually add ingredients while tracking the fact that such ingredients were added before approving the bag for distribution to a patient or other user.

An algorithm can be incorporated into the software and/or hardware of the controller <NUM> to determine if any bubble event requires the pump <NUM> to stop and for the user to verify if they accept the bubble that was sensed. A flow algorithm can also be incorporated in coordination with the use of pressure sensors to detect occlusions and/or flow pressures. Furthermore, it is conceivable that intelligent bubble handling technology can be incorporated into either the controller <NUM> or the occlusion or bubble sensor(s) 33o, <NUM>, 33o/b that monitors what has been delivered into the common volume (and attempts to determine a worse case bubble event). The technology can include hardware and/or software that causes the system to stop and require a user to accept or reject the operation depending on the presence (or lack thereof) of bubbles or an occlusion, etc. Software and/or hardware can also be provided that determines whether any occlusion or bubble event, when weighed against the size/volume of delivery, was large enough to effect accuracy, and provide a user with an automated or user defined option to accept or reject delivery of the end product.

The interface for the controller <NUM> can include dual display of stations that uses colors and/or numbers to identify each station. The screen for the controller <NUM> can include a first column that represents flex lines, a second and third column that represent micro lines, and a fourth or last column that represents macro lines. The screen can group the different (in this case, three) types of stations in order to present a clear picture of what fluids are at what station and what type of station it is. Of course, the number and arrangement of micro, macro and flex lines can change depending on a particular application for a different embodiment of the compounding system <NUM>.

The controller <NUM> can also be configured to require a username/password or bar coded badges to sign in/out. In addition, access can be further controlled to require username/password or bar coded badges for confirmation of required steps (e.g., addition of an ingredient that requires a prescription or that is in another way regulated).

The controller <NUM> can also be configured to display a real time status of the compounding event. For example, the controller <NUM> can display which solution(s) are currently being pumped from which station as well as how much solution is left in each source container 4a, b.

Templates can also be stored in the controller <NUM> to quickly and efficiently determine the set-up and sequence of ingredients for a particular application or a particular patient or user. A database located in or accessible by the controller <NUM> can include data related to storage, additions, removals of all drugs allowed for compounding and their associated data. The controller <NUM> can be configured to include multiple interfaces for the user and can be networked such that a plurality of compounding devices can be controlled and/or monitored by a separate entity or controller. In addition, a print wizard can be incorporated into the controller <NUM> software and/or hardware that automatically prints certain items when certain actions take place using the compounding device.

In another alternate exemplary embodiment, the occlusion sensor and bubble sensor can be positioned under the manifold common volume instead of being located in the manifold outlet tubing. Although locating the sensor area in the common volume in the manifold may make the flushing act slightly more difficult, the location of the bubble sensor in the common volume can allow a user to better discriminate which source line generated the bubble. For example, an array of bubble sensors could be located along the length of a common volume in the manifold to accomplish this feature.

In yet another exemplary embodiment, the filler <NUM> could be removed from the micro common volume (e.g., first channel 24a) and the inner diameter of the common volume could be reduced as compared to the volume depicted in, for example, <FIG>. This modification comes with certain complications in that manufacturing and design of the valves would be more complicated to affect the volumetric flow rates desired in the modified first channel 24a of the compounding device.

In another embodiment, the filler <NUM> could be configured with vanes on its outer diameter (OD) surface that induce turbulence and/or swirl to promote better flushing. Additionally, the filler <NUM> could be removable from the channel in order to provide an alternate flushing port. Likewise, the filler <NUM> could be removable such that different style fillers (e.g., fillers having different cross-sectional shapes, sizes, number and shape of vanes, etc.) could be used in the manifold <NUM>.

In yet another embodiment, a cross connect channel can be located between the downstream end of the micro and macro common volumes (e.g., the first channel 24a and second channel 24b). A valve could be provided to close this channel, allowing dispensing to occur as usual, and then the valve could be opened to allow the micro common volume to be flushed by the macro pump, which operates at higher flowrates and provide more efficient flushing.

As described above, the platen/lock arm design has springs in the lock arms that press the platens against the rotors <NUM>, <NUM> when the lock arms 44a, b are closed. An alternate approach would locate torsional springs at the platen hinge points (potentially inside the instrument) such that the platens are always spring loaded against the rotors. The platen lock arms 44a, b could be replaced by "platen disengagement arms" configured to pull the platens 43a, b away from the rotors <NUM>, <NUM> during transfer set installation and removal.

The pump output is a function of upstream suction pressure. To provide better volumetric accuracy, the occlusion sensor could be used to compensate for variations in upstream suction pressure and prevent alarms due to partial occlusions. In this approach, the number of commanded pump rotations and rotor speed could be adjusted based on the measured suction pressure during pumping.

In yet another embodiment, LEDs or other types of lights or light sources can be located in the top surface of the pump under each ingredient source line. The molded manifold would guide light into the source tubing line, possibly all the way up to the spike where a visual indication could be provided if a source container or line needs attention. The light or light source would be connected to the electronic control unit for the compounding device, which would dictate when and how to provide light to a particular location, depending on error codes, programming desires, reminder notices, etc..

While it has been disclosed that a plurality of different sizes and shapes of tubings/lines and containers can be connected to the compounding device, in yet another alternative configuration of the disclosed subject matter, the compounding device can be configured for use with only a single type of container and tubing, such as only macro lines and macro containers, or only micro lines and micro containers. In this manner, the compounding device can be an effective replacement for current compounding systems and applications that include only single types of containers and lines.

The number of channels can also vary and remain within the scope of the presently disclosed subject matter. For example, three, four or more different sized channels could be incorporated into the manifold. Similarly, more than one same shaped and sized channel could be included in the manifold <NUM>.

The strain relief clip <NUM> is disclosed as being pre-assembled to the lines <NUM> and <NUM>. However, it should be understood that the strain relief clip <NUM> or similar structure could be attached during use or installation of the manifold. Moreover, the strain relief clip <NUM> could be attached only when its function is needed for a particular application. Similarly, the strain relief clip <NUM> can be configured in various different shapes and sizes and attached at different locations on the line or tubing. The strain relief clip <NUM> could also be configured as a two piece structure that can be attached at different locations on a respective one of the lines. It is also contemplated that the strain relief clip <NUM> can be integrated into the bubble occlusion sensor or vice versa. In addition, the strain relief clip <NUM> can be configured as a dampening material, adhesive or putty that can be located at a portion of the line(s) and attached to the housing to dampen movement of the lines where strain would otherwise be present.

Claim 1:
A compounding device (<NUM>) for transferring materials from at least two distinct material sources (4a, 4b) to a final container (<NUM>), comprising:
a housing (<NUM>), the housing (<NUM>) defining a valve surface (10c) and a pump surface (10d);
at least one micro valve actuation device (102a, 102a') adjacent the valve surface (10c);
at least one macro valve actuation device (102b, 102b') adjacent the valve surface (10c);
a micro pump (<NUM>, <NUM>) located adjacent the pump surface (10d) on the housing (<NUM>); and
a macro pump (<NUM>, <NUM>) located adjacent the pump surface (10d) on the housing (<NUM>),
wherein the at least one micro valve actuation device operates (102a, 102a') with the micro pump (<NUM>, <NUM>) to convey material from at least one of the material sources (4a, 4b) to the final container (<NUM>), and the at least one macro valve actuation device (102b, 102b') operates with the macro pump (<NUM>, <NUM>) to convey materials from at least another one of the material sources (4a, 4b) to the final container (<NUM>),
wherein each micro valve actuation device (102a, 102a') includes a first stepper motor (102a), and each macro valve actuation device (102b, 102b') includes a second stepper motor (102b),
wherein each micro valve actuation device (102a, 102a') further includes a first actuator member (102a') controlled by the first stepper motor (102a) for rotating a micro valve (21a), and each macro valve actuation device (102b, 102b') further includes a second actuator member (102b') controlled by the second stepper motor (102b) for rotating a macro valve (21b), and
wherein the rotation of the first and second stepper motors (102a, 102b) and therefore the first and second actuator members (102a', 102b') and the micro and macro valves (21a, 21b) is clockwise, counter-clockwise, or any combination of these directions.