HK40060312B - Pharmaceutical compounding system and method - Google Patents

Description

Drug preparation systems and methods

Technical Field

Embodiments of the present invention relate to drug formulation systems and methods, particularly drug formulation systems and methods for combining various components.

Background Technology

Drug formulation involves a process of creating a customized medicine or pharmaceutical product to meet the therapeutic needs of a patient. This process may include combining ingredients using various tools to form a drug, which can then be administered to the patient via various methods, such as intravenous injection (IV). In some cases, drug formulation can be used to create a drug product specific to an individual patient.

Automated systems can be used in environments such as hospitals to automate the dispensing of IV syringes or bags. In some cases, robotic systems can be used in such systems to prepare sterile syringes, for example, for intravenous injection, based on commands received from the hospital pharmacy.

Summary of the Invention

The following implementation methods and aspects thereof are described and illustrated in conjunction with systems, tools and methods intended to be exemplary and illustrative, and not to limit the scope.

In one embodiment, a drug preparation system is provided, comprising a plurality of vials and containers, the system being arranged to extract substances stored in the vials and combine them in the containers to form a drug, wherein each vial is continuously held within the system during drug preparation.

The system may include a pump component, such as a syringe, for assisting in the combination of substances used to form a drug.

In some embodiments, the pump component is continuously held within the system during the composition of the substance to form a drug.

Possibly, a retainer is provided for clamping the pump component, wherein the retainer is in a loaded state within the system so as to initially load the pump component to be clamped into the system.

In addition to the exemplary aspects and implementations described above, other aspects and implementations will become apparent from the accompanying drawings and the following detailed description.

Attached Figure Description

Exemplary embodiments are illustrated in the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative rather than restrictive. However, the organization and operation of the invention, as well as its objects, features, and advantages, can be best understood by referring to the following detailed description, in conjunction with the accompanying drawings:

Figure 1A schematically shows a perspective view of an embodiment of the drug preparation system of the present invention in the home state;

Figure 1B schematically illustrates the drug preparation system of Figure 1A, wherein the pre-coverage is partially removed, exposing its interior;

Figures 1C and 1D schematically show enlarged cross-sections of the system in Figure 1B;

Figures 2 to 5 schematically illustrate the system of Figure 1 in various different states or operations; and

Figure 6 schematically illustrates a drug preparation system that is largely similar to the GUI illustrated in the previous figures for auxiliary setup and operating system.

It should be understood that, for the sake of simplicity and clarity, the elements shown in the accompanying drawings are not necessarily drawn to scale. For example, the dimensions of some elements may be enlarged relative to others for clarity. Furthermore, where deemed appropriate, reference numerals may be repeated in the drawings to indicate similar elements.

Detailed Implementation

Referring first to Figures 1A and 1B, a possible embodiment of the drug preparation system of the present invention is illustrated. In Figure 1B, a portion of the system's outer casing is removed to expose the otherwise hidden internal parts of the system.

Embodiments of the drug preparation system of the present invention can be used in various environments, such as pharmacies, for example, hospital pharmacies found in hospital settings. Embodiments of the drug preparation system can be arranged to prepare, substantially automatically, receptacles suitable for administering therapeutic substances.

Such a container may be an IV bag, an infusion bottle (etc.). In at least some embodiments, such a container may be formed of a relatively elastic and/or expandable material arranged to deform and thus allow liquid to enter and/or exit without significantly creating pressure changes within the container that could otherwise interfere with the operation of such a system.

In some embodiments, a controller associated with or included in such a system of the invention may be arranged to dispense such a container based on an order received from a hospital pharmacy (or similar). In the system embodiment illustrated in the drawings, such a container arranged to receive ingredients that may later be given to a patient is indicated by reference numeral 12.

The system 10 in the illustrated example may include one or more vials 14 (see, for example, an enlarged view of Figure 1C) arranged to store liquids, powders, etc. The vials 14 may be (possibly manually by a technician such as a pharmacist) removably fitted to corresponding docking stations 16 of the system, each docking station defining a docking plane P, and the system 10 may also be seen (see, for example, Figure 1D) as including a pump component 18, which, in the illustrated example, is specifically implemented as a syringe. Each vial may be arranged to include an opening, which may have a diaphragm at one end, and the vial may be clamped at a docking station 16 adjacent to its opening, wherein each opening may be parallel to the plane P of its docking station.

The syringe 18 can be (possibly manually by a technician such as a pharmacist) fitted to the system retainer 20, which can in turn be coupled to move together with the syringe manipulator 22. The syringe is fitted to the system 10 preferably in the system's "start" or "load" state, illustrated here by the system retainer located on the opposite left-hand side of the system. In the example provided in the figures, the syringe can be inserted through the system housing via opening 24, which provides access from the front of the system toward the retainer 20 (see opening 24 and the forward direction F and rearward direction R marked in Figure 1A).

Installing the syringe into its holder in the system's "loaded" state may include engaging (e.g., by snap-fit) the removable cap 17 located on the syringe needle to the system's cap clip 19; and engaging the syringe barrel and plunger to the holder's base 21 and oscillating member 23, respectively. After a new syringe is loaded into the system, the retaining member 13 can be controlled to push the retaining shaft 3 against the cap 17 to secure it firmly to the cap. The syringe can be seen to have an axial extension along axis L, and in this example, the oscillating member 23 can be controlled via manipulator 22 to move axially back and forth relative to the base 21 along axis L to allow material to enter or exit the syringe.

System 10 may include a laterally extending slider 28 extending along a laterally extending axis _YS generally parallel to the ground. In this example, slider 28 may be specifically implemented as a sliding screw coupled to actuator 37 (see actuator 37 and axes _YS and _YA marked in the enlarged view on the upper side of FIG1B). Actuator 37 may be controlled to rotate slider 28, thereby actuating syringe manipulator 22 together with retainer 20, and thus moving syringe along axis _YS .

Additionally, the manipulator 22 can be controlled to rotate the retainer 20 about a rotation axis R that extends generally forward and is perpendicular to the axis _YS . Furthermore, the manipulator 22 can be controlled to move the retainer 20 in a direction that is generally parallel to the axis L.

The syringe in the "loaded" state can be arranged such that its axis L is generally parallel to the ground and axis _YS , and moving the syringe out of the "loaded" state can include a "first" initial step, namely, pushing the syringe manipulator 22 and the syringe together along axis _YS in a direction away from the clamp 19 and the fixing member 13, in which the clamp and fixing member retain the cap 17 is clamped, thus exposing the needle of the syringe.

The vials 14 within system 10 may include liquid or dry (e.g., powder) type ingredients. In some embodiments, such as the illustrated embodiment, system 10 may be arranged to group vials according to the type of ingredient within the system. In the illustrated embodiment (see, for example, FIG1C), system 10 can be seen to include a first group 141 and a second group 142 of vials. The first group 141 and the second group 142 may include vials adapted to contain liquid type ingredients, while the second group 142 may include vials adapted to contain dry type ingredients.

The vials in the first group 141 can be substantially fixed in position within the system, with the opening of each vial facing downwards in this example. The vials in the second group 142 can be coupled to a pivot arm 30 adapted to rotate about an axis _YA that is generally parallel to axis _YS . In Figure 4, the system is shown in a state where arm 30 is pivoted approximately 180 degrees about axis _YA to position the vials of the second group 142 with their openings facing upwards; in the remaining figures, the system is shown with the opening of each vial in the second group 142 facing downwards. In some embodiments, arm 30 can be pushed to the position shown in Figure 4 to discard the vials held therein (possibly into drawer 100), preferably after the substance stored in these vials has been used to form a medicine.

Referring to Figure 2, a possible state of the system is illustrated, wherein the syringe has been moved to a position suitable for drawing substance from a vial within group 141. The movement of the syringe from the “loaded” state shown in Figure 1 toward the position shown in Figure 2 may include a “first” initial step of withdrawing the needle from the cap, followed by linear and/or rotational movements along a combination of axes Y, _S , L and about axis R.

Referring to the upper left of Figure 2, possible calibration procedures can be performed before piercing the opening of the vial with a syringe needle. In some cases, such as due to a faulty needle that may be slightly angled to the axis L of the syringe, calibrating the exact position of the needle tip can help to successfully advance it into the vial through the opening.

This calibration can be performed, for example, by means of a calibration device (such as calibration device 401 illustrated in the upper left of Figure 2). Calibration device 401 may include a transmitter that sends a signal 6001 (possibly an optical signal) and a receiver for receiving the signal. A syringe, guided to position its needle below the opening of the vial, can be guided to intercept signal 6001 to ensure that the needle is correctly oriented for insertion into the vial through the opening.

In one embodiment, the calibration device 401 and therefore the signal 6001 are arranged to detect the correct placement of the needle around the axis R. In at least some embodiments, the detection of the correct placement of the needle around the axis R can be obtained by guiding the signal 6001 along an axis generally parallel to the axis R.

Once signal 6001 is captured, possible “correction values” can be derived, which define “angle correction”, that is, rotation about axis R can be considered in order to properly “aim” the needle of a given syringe within the system to successfully enter or pierce the orifice, inlet or opening of a medicine bottle.

This "calibration value" can be taken into account when the syringe is rotated about axis R, allowing for the correct needle orientation to be achieved within the system. This correct orientation can be useful when advancing the syringe needle into or toward another position within the system, such as when attempting to insert the syringe needle back into its cap 17. A calibration device such as 401 can be mounted below and/or adjacent to the docking station 16 of one or more vials within the system.

After the substance is drawn from one or more vials, the syringe can be advanced as shown in Figure 3 to release the substance into the container. In some cases, the amount of substance drawn from the vial (of group 141 or 142) and inserted into container 12 can be specifically prescribed for an individual patient who can then receive the prescribed treatment, for example, via intravenous therapy.

Obtaining a substance (in this example, a dried component) from a vial of group 142 may include a reconstitution process in which a diluent is added to the dried component to make it a liquid. In the embodiment shown here, this can be achieved by first advancing a syringe to draw a dose of liquid from the container, as shown in Figure 3.

The syringe can then be advanced toward the vials of group 142, which can then be pushed into a position suitable for receiving liquid from the syringe. In the illustrated example, this position may include rotating the vials approximately 180 degrees via arm 30 to position the openings of these vials generally upward, as shown in Figure 4. The syringe can then be advanced with its needle generally downward to pierce one or more vials within group 142 and drain liquid into them.

In at least some embodiments, the system may include a vibrator, for example associated with each vial within group 142, to facilitate a reconfiguration process within the vial receiving the liquid. In some embodiments, such a vibrator may be configured to be adjacent to and/or close to a docking station 16 to which the vial is attached. For example, in some examples, the docking station may be positioned above the vibrator. The vibrator may be arranged to propel vibratory motion in several directions, such as along all axes of a Cartesian coordinate system, such as x1, y1, z1 marked in FIG. 1C, wherein, for example, the plane x1, y1 may be substantially parallel to the plane P of the vibrating docking station.

After the liquid has been received into the desired vials of group 142, arm 30 can be pushed to rotate the vials of group 142 upwards back to a position where their openings are generally facing downwards. A vibrator can also be activated during the upward pivoting of arm 30 to facilitate the reconfiguration process within the vials of group 142. After or during the upward and backward pivoting of the vials of group 142, a syringe can be advanced as shown in Figure 5 to draw substance from the previously liquid-filled vials, and then advanced to discharge the substance into container 12. Different vials may vibrate according to different vibration parameters. For example, different vibration parameters can be defined based on vial size, type of substance contained in the vial, etc.

After the required dose of substance from the vial is prepared into a container and/or if the vial is no longer needed in the system, the system can discharge the vial into a collection container 100, which may be in the form of a drawer from which the empty vial can be discarded.

Referring to Figure 6, a drug preparation system substantially similar to the drug preparation system discussed in the previous embodiments is illustrated, wherein a GUI 1000 communicating with and/or associated with the system is provided exemplarily to assist in setup and/or operating system.

The GUI 1000 can present the required loading arrangement of vials within the system based on specific patient information and/or the required medication. The GUI can clearly indicate where to place each vial; in this example, it indicates placing four vials in four first docking stations from left to right. Instructions provided in the GUI can additionally indicate the type of medication or ingredient within each vial to ensure correct vial placement according to the medication in the vials within the system.

Additional devices used to assist in the correct placement of medicine bottles within the system may include LED indicators, such as adjacent docking stations within the system, that mark where to place individual medicine bottles and/or sensors (such as barcode readers that may be arranged to detect barcodes placed on medicine bottles mounted to the system) to ensure that the correct medicine bottle has been loaded into its intended docking station within the system.

Parameters that can be provided to the processor may include: syringe size or type, needle type mounted on the syringe, and ingredients used according to the prescription(s), which the processor controls the correct preparation of various ingredients for a given patient according to the required prescription. Data related to syringe type or size can be used, for example, to correctly guide the syringe through the system, such as correctly positioning the system's retainer in the loading state so that the syringe can be easily assembled into its position without interfering with other parts within the system.

Data related to needle type can, for example, help determine appropriate rates for withdrawing substances from vials or containers that largely avoid drawing air out of the vial or container along with the liquid substance being drawn. For instance, a relatively thick needle with a relatively wide lumen can allow for a higher rate of substance withdrawal than a relatively thin needle with a relatively thin lumen.

In the specification and claims of this application, each of the verbs “comprising” and “having” and their inflections, used to indicate the object of the verb, is not necessarily a complete list of the components, parts, elements or components of the subject of the verb.

Furthermore, although this application has been illustrated and described in detail in the accompanying drawings and the foregoing description, such illustrations and descriptions are intended to be illustrative or exemplary and are not restrictive; thus, the technology is not limited to the disclosed embodiments. Those skilled in the art, in practicing the claimed technology, will understand and implement modifications to the disclosed embodiments from the study of the drawings, the technology, and the appended claims.

In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude a plurality. A single processor or other unit can perform the functions of several items listed in the claims. The simple fact that specific measures are listed in different dependent claims does not indicate that a combination of these measures cannot be advantageously used.

If terms, features, values, or ranges are used herein in conjunction with terms such as "approximately," "close to," "substantially," "generally," or "at least," then the art is also to be understood to include such exact terms, features, values, or ranges. In other words, "approximately 3" should also include "3," or "substantially vertical" should also include "vertical." Any reference numerals in the claims should not be construed as limiting the scope.

Although this embodiment has been described to a certain extent, it should be understood that various changes and modifications can be made without departing from the scope of the invention as claimed below.

Claims (16)

1. A drug preparation system (10) comprising at least one vial (14) and a container (12), the system being arranged to remove a substance stored in the at least one vial for discharge into the container to form a drug, wherein, during the removal, discharge, and preparation of the drug, each vial is continuously held within the system, wherein, The vial is removably assembled within the system, and wherein, The system includes multiple docking stations (16) adapted to hold medicine bottles, wherein at least one medicine bottle stores a liquid substance and at least one other medicine bottle stores a powder substance, and wherein at least some (141) of the medicine bottles storing liquid are held substantially fixed in place within the system. Its features are, All the vials (142) storing the powder can move within the system while being continuously clamped; The system also includes a pump assembly for assisting in the removal and discharge of substances for forming the drug, and a retainer for holding the pump assembly, wherein the retainer includes a base and a swinging member controlled via an actuator of the pump assembly to move axially back and forth relative to the base along a linear axis to allow substances to enter or exit the pump assembly. The system further includes a calibration device for detecting the position of the needle of the pump component within the system to generate a calibration value. The calibration device includes a transmitter for sending a signal and a receiver for receiving a signal, wherein the pump component is guided to position the needle below the opening of the vial and the pump component is guided to intercept the signal. Once the signal is intercepted, a calibration value is derived. The calibration value is taken into account when the pump component is driven to rotate about a rotation axis perpendicular to the linear axis, thereby obtaining the correct orientation of the needle within the system. The detection of the correct placement of the needle about the rotation axis is obtained by guiding the signal along an axis parallel to the rotation axis. 2. The system of claim 1, wherein the pump component is a syringe, and wherein the pump component is continuously clamped within the system during the extraction and discharge of the substance for forming the drug. 3. The system according to claim 1 or 2, wherein the retainer is placed in a loading state within the system to initially load the pump component to be clamped into the system, and wherein loading the pump component into the system in the loading state includes clamping a cap on a needle located within the system, and wherein pushing the pump component out of the loading state includes removing the needle from the cap. 4. The system according to claim 1 or 2, wherein the pump component is arranged to move within the system along at least one axial linear axis and about at least one rotational axis. 5. The system according to claim 1 or 2, wherein the vial is manually removably assembled within the system. 6. The system according to claim 1 or 2, wherein the container is adapted to later administer the drug to the patient. 7. The system of claim 1, wherein the movement of the powder-storing vials comprises moving the vials between a position in which the opening of the vials is generally facing downward and a position in which the opening of the vials is generally facing upward, wherein the movement comprises pivoting all the powder-storing vials about a common axis. 8. The system of claim 7, wherein, prior to movement, the moved vial is locked to a corresponding docking station adapted to hold the vial, and the system includes one or more vibrators for vibrating the vial containing powder, and also vibrating the vial containing powder during movement, wherein the vial is continuously held within the system during vibration. 9. The system of claim 6, wherein the container is an IV bag or an infusion bottle. 10. The system of claim 7, wherein the movement of the medicine bottle storing the powder includes moving back and forth between the positions at least once. 11. A method for combining various substances in a pharmaceutical formulation system, the method comprising the steps of: A drug preparation system (10) is provided, the drug preparation system including a pump component (18), at least one vial (14) for storing liquid or powder, at least one container (12) and a retainer for holding the pump component, wherein the retainer includes a base and a swinging member controlled by an actuator of the pump component to move axially back and forth relative to the base along a linear axis so as to allow substances to enter or exit the pump component; Actuate the pump component to draw substance from the at least one vial; and The substance extracted from the at least one vial is discharged into the container to form a drug, wherein, Extracting a substance from a vial containing powder includes: first moving the vial from an initial position where the opening of the vial is generally facing downwards to a position where the opening of the vial is generally facing upwards; The system further includes a calibration device for detecting the position of the needle of the pump component within the system to generate a calibration value. The calibration device includes a transmitter for sending a signal and a receiver for receiving a signal, wherein the pump component is guided to position the needle below the opening of the vial and the pump component is guided to intercept the signal. Once the signal is intercepted, a calibration value is derived. The calibration value is taken into account when the pump component is driven to rotate about a rotation axis perpendicular to the linear axis, thereby obtaining the correct orientation of the needle within the system. The detection of the correct placement of the needle about the rotation axis is obtained by guiding the signal along a path parallel to the rotation axis. 12. The method of claim 11, wherein extracting a substance from a vial comprising liquid comprises: moving the pump member toward the vial to extract the liquid substance from the vial, and then moving the pump member to discharge the substance into the container. 13. The method of claim 11 or 12, further comprising the steps of: actuating the pump member to draw liquid from the container while the vial comprising powder is oriented with the opening of the vial generally facing upward to form a remodeling process in the vial, and then discharging at least a portion of the liquid into the vial comprising powder, including vibrating the vial. 14. The method of claim 13, wherein extracting the substance from an initially powder-containing vial comprises: pushing the vial back toward a position generally downward toward the opening of the vial after undergoing a remodeling process in the vial. 15. The method of claim 11 or 12, comprising at least one initially liquid-type vial and/or at least one initially powder-type vial, wherein the vials are grouped according to the type of substance stored therein, and wherein the system includes at least one vibrator arranged for vibrating the powder-type vials, and wherein the system further includes a GUI for assisting in setting up and operating the system, wherein the GUI is arranged to present a desired loading arrangement of the vials within the system based on specific patient information and/or the desired medication, and wherein, after the medication is formed, the vials and/or pump components clamped within the system are released from their clamps and discarded. 16. The method of claim 11, wherein extracting a substance from a liquid-containing vial comprises: moving the pump member toward the vial to extract the liquid substance from the vial, and then moving the pump member to discharge the substance into the container, while the liquid-containing vial remains substantially fixed in place throughout the system.