Machine and method for the automatic preparation of substances for intravenous application
10543941 ยท 2020-01-28
Assignee
Inventors
- Borja Lizari Illarramendi (Araico, ES)
- Naiara Telleria Garay (Arrasate-Mondragon, ES)
- Asier Lizarriturri Martiarena (Aretxabaleta, ES)
- Ana Belen Barrio Jimenez (Vitoria-Gasteiz, ES)
- Amaia Ilzarbe Andres (Donostia-San Sebastian, ES)
- Jose Ignacio Andres Pineda (Vitoria-Gasteiz, ES)
Cpc classification
B65B7/28
PERFORMING OPERATIONS; TRANSPORTING
B65B7/2828
PERFORMING OPERATIONS; TRANSPORTING
B65B39/12
PERFORMING OPERATIONS; TRANSPORTING
B65B43/54
PERFORMING OPERATIONS; TRANSPORTING
B65B3/04
PERFORMING OPERATIONS; TRANSPORTING
A61J3/002
HUMAN NECESSITIES
B65B7/2835
PERFORMING OPERATIONS; TRANSPORTING
International classification
B65B3/00
PERFORMING OPERATIONS; TRANSPORTING
B65B39/12
PERFORMING OPERATIONS; TRANSPORTING
B65B7/28
PERFORMING OPERATIONS; TRANSPORTING
B65B3/04
PERFORMING OPERATIONS; TRANSPORTING
Abstract
A machine and a method are for the automatic preparation of substances for intravenous application. The machine includes a container receiving zone which defines a matrix of individual positions for initial and final containers, and a number of actuators for transferring substances from initial container to final container. Each of the actuators is positioned beneath the zone for receiving initial and final containers, each of the actuators is able to move relatively, independently of the rest of the actuators, and each of the actuators is suitable for receiving and operating injectors with different volumes and degrees of precision in order to remove substances from initial containers and insert them into final containers.
Claims
1. A machine for the automatic preparation of substances for intravenous application comprising: a container receiving zone which defines a two-dimensional matrix of individual positions for initial and final containers arranged on a plurality of metering lines; a plurality of actuators for transferring substances from initial container to final container, each of said actuators being positioned beneath said zone for receiving initial and final containers, each of said actuators being able to move relatively, independently of each other, along a horizontal guide parallel to one of said plurality of metering lines of said matrix, each of said actuators being configured to receive and operate injectors with different volumes and degrees of precision in order to remove substances from initial containers and insert them into final containers, wherein each injector comprises an adaptor arranged on an inlet/outlet port for direct connection to/disconnection from respective initial/final containers.
2. The machine according to claim 1, wherein each of the actuators for transferring substances can move vertically and horizontally independently of the rest of the actuators.
3. The machine according to claim 1, wherein the actuators comprise rotation actuators for twisting and untwisting any stoppers arranged in the inlet/outlet ports for substances of the respective containers and rotation actuators for connecting and disconnecting the inlet/outlet ports of the injectors to/from the inlet/outlet ports of the respective containers.
4. The machine according to claim 1, wherein the actuators comprise holding actuators for holding and operating plungers of said actuators.
5. The machine according to claim 1 further comprising automatic actuators for removing, holding and inserting injector caps.
6. The machine according to claim 1, wherein said injectors consist of syringes having a piercing point.
7. The machine according to claim 1, wherein said injectors consist of syringes having no piercing point.
8. The machine according to claim 1, wherein the adaptor is a Luer-Lock adaptor.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) To better understand the machine according to the present invention for the automatic preparation of substances for intravenous application, the accompanying drawings show an embodiment thereof as an explanatory but non-limiting example.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(16)
(17) The traceability zone is the zone where the user controls the loading and unloading of the material to be used, and comprises different devices for the control and traceability of all the types of initial and final containers that are involved in the automatic preparation of substances for intravenous application. Said devices, which are distributed between both modules (2, 3), may comprise, among others, a touch screen 21, a printer 22, a set of scales 31, different RFID or bar code readers (not shown) and different enabling and/or emergency switches (not shown). The features of each element will be explained in more detail below.
(18) The preparation zone, which is located exclusively in the module 3 (horizontal laminar flow cabinet) of the machine 1, is the zone where the initial and final containers are arranged and where products or substances are automatically metered from said initial containers to said final containers. Said preparation zone is made up of two distinct sub-zones: (a) A first sub-zone 32 which comprises a preparation tray 4 (see
(19) As will be explained in more detail below, the metering carried out by the machine 1 according to the present invention takes place using syringes 5 which are operated by each actuator (331, 332, 333) of each metering line respectively. Accordingly, the machine 1 comprises in the second sub-zone 33 a front-access door 34 allowing access to the loading and unloading of the syringe 5 of its respective actuator.
(20) In general, the syringes used in the present invention may be of the type that comprises a Luer-Lock distal nozzle. Said Luer-Lock nozzle, widely known in the prior art, particularly in the health sector, consists of a male screw-type connection which enables connection of elements such as a piercing point, or a female Luer-Lock adaptor, thus providing a secure and hermetic seal, avoiding leaks and direct contact risks. The locking system using Luer-Lock connections secures the needle or any adaptor so that it cannot move or be broken off the syringe. It should be noted in addition that, in the health sector, where a syringe has a distal end comprising a Luer-Lock connection, said Luer-Lock connection is normally known as the male connection, whereas at the point where said male Luer-Lock connection is coupled the Luer-Lock connection is known as the female connection, such as said port of a container, a needle or an adaptor.
(21) The dimensions of the module 2 in the configuration of the machine shown in
(22) Dimensions of the module 3 such as those above allow a tray 4 to be arranged defining a matrix of 123 elements, or in other words, twelve elements per metering line, the first four of which, for example, starting at the right of the tray 4 are initial containers 40 and the next eight elements are final containers 41. Different combinations of initial and final containers are possible depending on the requirements of each case. Similarly, the tray 4 may have smaller or larger dimensions.
(23) The horizontal laminar flow cabinet is characterised by having the following common systems, which it should include: Fan motor system (not shown); HEPA (high-efficiency particle arresting) air filters: said high-efficiency filters are known in the prior art and avoid the propagation of bacteria and viruses through the air; they are therefore very important for preventing infections.
First Embodiment of the Preparation Zone
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(25) According to this first embodiment, the tray 4 comprises a plurality of support elements 44 for receiving any type of container, such as flasks, syringes or bags. However, although the standard volume of a bag-type container could occupy all the receiving space of one element 44, other types of container, such as a flask or a syringe, could occupy half the space of an element 44. Consequently, a support element 44 in the tray 4 could be used to house at least two flasks 40 or two syringes 41, allowing the storage capacity of said tray 4 to be doubled, as illustrated in
(26) Alternatively, starting at the right of the tray 4, for each metering line four flasks 40 could first be arranged as initial containers and then four infusion bags as final containers.
(27) In addition, depending on the type of container to be housed in each of the support elements 44 of the tray 4, a specific adaptor could be used for each type of container, and the elements 44 will, in turn, be capable of universally housing any type of container having its respective adaptor. The correct position of the adaptors on the tray 4 can be ensured by foolproof systems to minimise and avoid connection errors. Thus, a flask adaptor, a syringe adaptor or a bag adaptor can be placed in each support element 44 without the need to fit any additional component, allowing the syringe 5 to always maintain the same horizontal position of the injection point in each of said recesses 44. Thus, the vertical movement distance of the respective actuator (331, 332, 333) will be the same for any type of container. In addition, high flexibility is obtained when making preparations as more or fewer flasks, more or fewer syringes or more or fewer bags can be loaded depending on the requirements in each case.
(28) With regard to the container adaptors, said adaptors can take the form of a wedge (not shown) so as to centre the container at the same point of the element 44. In addition, by using ball positioners arranged in the elements 44 (not shown) in the tray 4, the adaptors can always be fitted in the same position in each support element 44. Moreover, the elements 44 may have an automatic or manual system for retaining and releasing the adaptors, ensuring that the adaptor does not move vertically when the syringe 5 punctures the port of the container.
(29) In the case of syringe adaptors or other types of container such as infusers or cassettes, the holding will take place at said connection point, which may consist of a female-female Luer-Lock connector. Said holding will therefore be valid for any type of syringe, provided it has a Luer-Lock connection.
(30) In addition, each container adaptor may carry an RFID label to identify at all times the type of substance or medicine contained in the container which is fitted in said adaptor. The substance metering process can thus be traced and controlled for each operation.
(31) Each of the actuators (331, 332, 333) may also comprise an RFID antenna to check, prior to puncturing, that the medicine or substance in the container placed in the recess 44 is the correct one.
(32) Alternatively, bearing in mind that the use of infusion bags as initial or final containers could result in too much space being occupied in the tray 4 and that, on occasion, said bags can be very unstable, it would be possible for said bags to be hung from hooks arranged in said first sub-zone 32.
(33) In addition, in this first embodiment, the metering takes place through the use of syringes 5 having piercing points, said syringes being operated respectively by an actuator (331, 332, 333) arranged on a respective horizontal guide (3310, 3320, 3330) each defining a metering line. Said actuators (331, 332, 333) can move independently along the respective horizontal guide (3310, 3320, 3330). In principle, for each metering operation, the movements of each actuator (331, 332, 333) will be from right (where the initial containers 40 are located) to left (where the final containers 41 are located).
(34) Furthermore, in this first embodiment, there is one mechanism 42 for holding the caps of the needles of the syringes 5 for each metering line. Said mechanism 42 for holding the caps of the needles of the syringes 5 is arranged to the right of the initial containers 40.
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(37) In
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(41) Each actuator (331, 332, 333) according to this first embodiment can perform the operations as described with reference to
(42) Once a substance transfer operation has taken place between an initial container and a final container, and whenever the syringe 5 needs to be changed, the actuator 331 is placed so as to position the holder 3313 of the syringe 5 beneath the mechanism 42 for holding the caps of the needles of the syringes 5. By moving the carriage 3311 along the vertical guide 3312, the piercing point 52 of the syringe 5 is inserted inside the cap 51, which is held by a clamp (not shown) of the mechanism 42 which retains said cap 51. Once the piercing point 52 of the syringe 5 has been inserted inside the cap 51, the clamp of the mechanism 42 releases the cap 51 and by moving the carriage 3311 along the vertical guide 3312, the assembly (syringe 5, cap 51) moves back downwards allowing an operator to subsequently unload the syringe 5, having its piercing point 52 covered by the corresponding cap 51, through the front access door 34 of the machine 1 (see
(43) In addition, the actuators (331, 332, 333) may have a visual control camera (not shown) which allows the type of syringe 5 loaded in said actuators (331, 332, 333) to be checked at any time. Said camera can also check whether substances have been correctly removed and/or inserted between initial containers and final containers and can even detect whether air has been removed at any time.
Second Embodiment of the Preparation Zone
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(45) In this second embodiment, as will be explained in more detail below, metering takes place using syringes 7 having no piercing point, operated by a respective actuator 6 along a horizontal guide 60. The barrel 71 of each syringe 7 comprises a female-female Luer-Lock adaptor 710 arranged on its respective inlet/outlet nozzle, as shown in
(46) Each actuator 6 comprises, on one side, an actuator 61 for twisting and untwisting the stoppers of the initial and final containers and, on the other side, an actuator 62 for connecting and disconnecting the respective nozzles of the syringes 7 to/from the respective initial and final containers and subsequently to insert and/or remove substances between the initial and final containers.
(47) The actuator 61 comprises a seating component 613 provided with a groove 614 for receiving stoppers of the initial and final containers. Said seating component 613 can rotate in order to twist and untwist said stoppers, and can move vertically along a vertical guide 615. In addition, said actuator 61 comprises a carriage 610 that can slide vertically along a vertical guide 611 which comprises rigidly connected clamps 612 for actuating the plunger 74 of the syringe 7.
(48) On the other hand, the actuator 62 is made up of a rotary actuator 623 for adaptors 710, which comprises a first central guide 628 through which passes a through-hole 624 for receiving the distal portion of the syringe 7 having its corresponding adaptor 710. Said first central guide 628 can rotate by means of the action of a second guide 626 actuated by a motor 625, said first guide 628 and second guide 626 being connected by a transmission belt 627. The assembly (actuator 623 and motor 625) together with its respective guides (first central guide 628 and second guide 626) can move vertically along a vertical guide 629.
(49) Said actuator 62 also comprises a syringe barrel holder 620 that can move vertically along a vertical guide 621. Said syringe barrel holder 620 comprises a plurality of grooves 622 suitable for receiving different types of adaptor 720 for different types of syringe. In reality, the syringe 7 which is loaded in the holder 620 to remove and insert substances is held by a syringe adaptor 720, as shown in
(50)
(51) In
(52) Next, and as illustrated in
(53) Next, the actuator 6 is moved horizontally to the left of its horizontal guide 60 so as to position the rotation actuator 623 of the actuator 62 beneath the initial syringe 80. At the same time, the carriage 610 is moved vertically upwards, along the vertical guide 611, in order to insert the distal zone of the syringe 7 having its corresponding adaptor 710 through the through-hole 624, such that the adaptor 710 is facing the nozzle of the syringe 80, as can be seen in
(54) As illustrated in
(55) Finally, and as illustrated in
(56) Next, the actuator 6 is moved along its respective horizontal guide 60, so as to position the seating component 613 of the actuator 61, comprising the respective stopper 9 of the syringe 80, exactly beneath said syringe 80. Next, said seating component 613 is moved closer to said syringe 80 with the aid of the vertical guide 615 so as to insert the stopper 9 into the nozzle of the barrel of the syringe 80. Next, the motor 10 having a central shaft 101 rotates the seating component 613 in the opposite direction so as to twist the stopper 9 into the nozzle of the syringe 80.
(57) The actuator 6 is then be able to insert the substance contained inside the syringe 7 into any final container 81 using an analogous and similar process to that explained earlier by making use of the actuators 61 and 62.
(58) Each actuator 6 according to this second embodiment can carry out the operations described with reference to
(59) In addition, the actuators 6 may have the same elements included in the actuators (331, 332, 333) of the first embodiment.
(60) Traceability Zone
(61) As mentioned earlier, the traceability zone is distributed between the modules (2, 3) of the machine 1 according to the present invention with the following peripherals:
(62) (i) Peripherals of the Module 2 Touch screen 21: an information screen with access to prescriptions in order to load material appropriately and monitor the automatic filling process; Printer 22: for double-labelling the final products, before and after preparation, and the flasks. An example of a printer could be the Zebra series GK420D printer, among others. RFID code reader, such as the Omron V680 system, for example. The label of the final product can be printed on reading the RFID of the adaptor of the final container, so as to place the label on the appropriate final container. Emergency push button: Stops the machine in an emergency.
(63) (ii) Peripherals of the Module 3 Scales 31: for weighing each product before and after preparation. It is used to ensure the accuracy and precision of the metering process. An example set of scales could be the Metler Toledo ref. MI3002/01 scales, among others. These scales have a tray, used to weigh infusion bags effectively. Dataman 200S bar code reader. RFID code reader such as the Omron V680 system, for example. Enabling switch: used to start automatic preparation once the initial and final containers have been correctly loaded. Display (not shown): allows step-by-step monitoring of what is being carried out. Emergency stop button: Stops the machine in an emergency.
(64) In general, when initial and final containers are loaded on the tray 4, the following steps may be followed for each loading of the initial or final container: place the container in its corresponding adaptor; read the bar code on the container. If it is an infusion bag or syringe, weigh said bag or syringe; read the RFID of the adaptor; a green light (LED) will be illuminated in the position of the tray 4 where the respective container should be placed (the LEDs are not shown in the figures); place the respective container in the tray 4 and confirm; previously illuminated light switched off.
(65) For unloading, the opposite process will be followed. If any of the initial containers is a flask, they will not be weighed. The programmable logic controller (PLC) of the machine 1 will check the quantity of medicine remaining in the flask, as it already knows the quantity held in the flask initially and the number and volume of the removals carried out. The RFID of the flask adaptor will be read and the corresponding adhesive label applied. For unloading the final containers, said containers will be weighed, the RFID of the adaptor will be read and said containers re-labelled. Accuracy is thus ensured. When a reconstitution process takes place, the flasks will be the final container, and like all the final products, will be weighed.
(66) Although the invention has been described in relation to preferred embodiments, said embodiments should not be considered to limit the invention, which will be defined by the widest interpretation of the following claims.