This application claims priority to European Patent Application No 22382634.8 filed on Jul. 1, 2022, the disclosure of which including the specification, the drawings, and the claims is hereby incorporated by reference in its entirety.
The present application relates to a machine for the preparation of medical product, specifically to a machine with a device for loading bags of medical product in said machine.
Automated machines for the preparation of medical products, such as the preparation of intravenous medication, for example, and for filling or loading medical containers, in other words containers with a medical product, are known. An example of such machines are dosing machines. These types of machines or devices are usually made up of a laminar flow cabinet and robotic means in the interior thereof which performs the necessary movements for removing medicine from a source container and injecting said medicine into end medical containers. The medicine is injected into the medical containers through an injection or dosing point located on the medical container.
These machines may comprise a worktop with holes for introducing the dosing points of the medical containers. Once introduced, robotic means of the machine fill the various medical containers by introducing the medical product into a dosing point of the container. In this type of dosing machine with a worktop, the robotic means for filling containers are positioned inside the machine, beneath the worktop and arranged below the containers such that the dosing point of the medical container is situated below the worktop. Other types of dosing machine may use safety barriers which separate the load from the robotic means without using a worktop.
A problem with dosing machines that have a worktop is the introduction or loading of the medical containers into the machine. Most dosing machines are designed for filling a specific type of medical container and comprise supports for said type of container. However, a very sought-after characteristic of these machines is to have flexibility for loading various types of containers. Machines are known that allow different types and makes of end medical containers to be supported, in which the dose of the preparation is introduced using specific adaptors for each container arranged in holes in the machine, which offer great flexibility of use and allow batch working for different types of end medical containers (syringes, bags, infusers, cassettes, etc.). These adaptors must be introduced into the adaptor supports of the machine before beginning a batch of preparations. Spanish patent document ES2643119 B1 discloses an example of an adaptor for a dosing machine.
A known method for loading containers consists in the operator removing the adaptors from the machine, introducing the medical containers into the adaptors and then placing the adaptors, with the containers incorporated, back into the supports for said adaptors of the machine. Said current manual placing method has the drawback of having to remove and place all the adaptors of the machine before preparing a batch. Therefore, when producing long batches, which is one of the most common applications of this type of machine, where high productivity is particularly valued, loading and unloading the containers individually becomes slow and tedious.
Another known method of loading containers consists in first arranging the adaptors in their supports in an operating position of the machine and then placing the containers therein. In the case of a dosing machine with a worktop, the adaptors of the machine are placed such that the dosing points of the containers are arranged towards the inside of the machine once positioned and the containers are then placed in the adaptors without being removed.
If the medical containers are bags, in said machine operating position the bag adaptors are positioned beneath the worktop so that the bag can be filled through the dosing point. There is therefore very little space for the operator to be able to introduce the bags, which is very inconvenient. Moreover, it is difficult to see the connection point as the dosing point of the machine is below the visual field of the operator. This may result in poor positioning of the dosing point of the bag.
An object of the present invention is to disclose means for facilitating the introduction of the containers into the machine, to achieve greater speed in loading medical containers, a reduction in the force required from the operator when loading the material, and a reduction in the level of concentration required of the operator to load the material correctly. Another object is to disclose means that make it possible to work both in batch mode and in patient-specific mode (a specific preparation for a particular patient), in other words, making use of different types of end containers and/or doses in the same loading cycle (in this case, the same type of medicine is dosed on each line of the machine).
More specifically, the present invention discloses a machine for the preparation of medical product which has a device for loading a medical product in said machine. Said device comprises a shaft with the ability to rotate, a plurality of adaptors for housing injection points of bags of medical product which are arranged on the shaft, such that the rotation of the shaft causes the adaptors to rotate. The device also comprises two stops which limit the rotation of the shaft. Said stops define a position for loading bags by an operator and an operating position of the machine.
The present invention therefore discloses a machine that allows bags to be placed in the adaptors of the device in a first loading position. From said loading position, the device allows the adaptors to rotate in order to place said adaptors in an operating position of the machine in which the dosing point of the bags is positioned in the correct direction for filling. This allows the bags to be placed in the adaptors in a convenient loading position for the operator, and also increases the visibility of the connection point for the operator during loading, while allowing subsequent rotation thereof in order to position the adaptors, and therefore the dosing points of the bags, in the operating position.
Preferably, the operating position of the machine is a position in which the injection points of the bags are positioned beneath the worktop of the machine.
Preferably, the device for loading bags comprises a lever mechanically connected to the shaft, actuation of the lever causing the shaft to rotate.
Preferably, the device comprises a guide, the ends of which define the stops. More preferably, the lever comprises a protrusion, said protrusion of the lever being housed in the guide, such that the protrusion is guided by said guide during the actuation of the lever. Still more preferably, the guide comprises a curved central segment and end segments situated at the ends of the central segment, there being a change of direction between the central segment and the end segments, such that the end segments correspond to the bag loading position and the operating position of the machine. In an especially preferred way, the lever comprises an actuator with a pusher and elastic position recovery means for the pusher, such that the actuator allows the relative position of the protrusion with respect to the lever to be modified, facilitating the passage of the lever from the end segments to the central segment and vice versa.
The end segments, particularly in combination with the actuator, allow the position of the device at the ends of the guide to be locked, such that the protrusion cannot pass accidentally from the end segments to the central segment without previously actuating the actuator.
Preferably, the end segments are arranged so as to extend perpendicular to the rotational movement of the lever. This means that while the protrusion is positioned in an end segment, it is not possible to rotate the shaft.
Preferably, the device is in the form of a tray. Also preferably, the device for loading bags of medical product may comprise handles for manual handling. Also preferably, the guide may be arranged in one of said handles.
Preferably, the machine is a machine for dosing medical products, more preferably, for dosing intravenous medicines, still more preferably non-cytostatic intravenous medicines (for example, antibiotics or anaesthetics). Preferably, the machine comprises at least one hole for introducing the injection point of bags of medical product for filling, said hole being arranged in or below a worktop of said machine.
Preferably, the plurality of adaptors is arranged on the upper portion of the shaft. In this way, the positioning of the dosing points of the bags in their housings on being introduced into the device of the machine is facilitated. Preferably, the adaptors are adaptors for bags. More preferably, the adaptors are adaptors for bags with a Luer-Lock termination (also known as a Luer-Lock connector). Alternatively, the adaptors are adaptors for bags with another type of connector or termination. In this other type of bag, the dosing point could be accessed, for example, by the robotic means of the machine using a needle. Preferably, the shaft is cylindrical. Alternatively, the shaft is cylindrical in part.
Preferably, the shaft is housed inside a housing of the lever, and is secured thereto by dimensional interference, for example. More preferably, the shaft comprises planar faces in the area housed in the housing in order to produce said dimensional interference during the rotation of the lever and shaft. More preferably, comprises the shaft comprises at least four of said planar faces. Preferably, the portion of the shaft connected to the lever is an end of said shaft.
Preferably, the adaptors comprise push-fitting means for the injection points of the bags of medical product. More preferably, the adaptors comprise an area of the housing which comprises at least one planar face, said adaptor comprising push-fitting means for at least one valve of at least one bag with a Luer-Lock termination. Said planar face helps ensure that the bags with a Luer-Lock termination do not rotate. Alternatively, the adaptors might not comprise an anti-rotation system. Preferably, the adaptor comprises an upper stop. Said upper stop improves the securing of the bag.
Preferably, the device for loading bags of medical product is removeable. More preferably, the device for loading bags of medical product comprises fastening means to the worktop of the machine. Still more preferably, said fastening means comprise claws arranged on the lower portion of the device, said claws being L-shaped such that the distal portion of the claw is beneath the worktop after placing the device on said worktop. Preferably, the device comprises a rear portion for the arrangement thereof on the worktop of the machine. More preferably, the device comprises connection structures between the rear portion and the shaft.
Preferably, the machine comprises a cross-piece for supporting the bags of medical product in the operating position of the machine. More preferably, said cross-piece is positioned on the device for loading bags. More preferably, the cross-piece comprises at least one side segment, said side segment being arranged on a connection structure of the device. When the bags are positioned, depending on the length of the bag, the worktop may be covered, making it difficult to see said worktop. Said cross-piece allows the bags to be supported to avoid said visual interference. Still more preferably, at least one side segment of the cross-piece comprises a groove, said groove of the cross-piece being arranged preferably at an end of the side segment in contact with the connection structure of the device. In addition, the connection structure comprises a through-element arranged in said groove, the dimensions of the groove being greater than those of the through-element. Movement of the cross-piece allows extension thereof into a vertical position to give support to the bags or the compressed arrangement thereof.
Furthermore, the groove with the through-element allows the cross-piece to fall by gravity until positioned on the through-element at the moment when a vertical position is adopted, locking or preventing unwanted movement thereof during operation.
Preferably, the device comprises radiofrequency identification (RFID) tags. Said tags allow the various elements such as containers, adaptors or supports for said adaptors to be identified. The use of RFID antennae or tags allows the types of adaptors loaded into the machine to be identified and provides confirmation that it is the correct container type (bag, syringe, infuser, cassette, etc.) where the dose should be injected.
The present invention also discloses a method for loading bags of medical product into a machine for the preparation of medical product according to any one of the preceding claims, which comprises the steps of:
As used in the present document, the term “medical container/s” refers to any type of container used in medicine for storing, preparing or administering medicines (for example, intravenous medicines, such as non-cytostatic intravenous medicines including antibiotics and anaesthetics) and other solutions used in intravenous treatments (such as physiological solutions, saline solutions or nutritional solutions). The concept “medical product/s” is used in the present document to refer to these medicines and other solutions.
As used in the present document, the terms “dosing point/s” and “injection point/s” refer to the point or element of the medical container through which said container is dosed, in other words, the point through which the medicine (preferably intravenous medicines, such as non-cytostatic intravenous medicines including antibiotics and anaesthetics) or intravenous treatment solution (such as physiological solutions, saline solutions or nutritional solutions) is introduced into the medical container.
With regard to the types of medical containers, bags with a Luer-Lock termination are known, the dosing points of the bags are situated in their valves, which are the dosing point thereof. The Luer-Lock system is a standardised thread system for medical devices and fluid accessories such as syringes, bags, infusion equipment, etc. which comprises a closure with a rotating thread to allow syringes, bags, etc. from different manufacturers to be combined, facilitating the fastening of the actuators of the machine (for example, needles) to the dosing point. Also known are bags without a Luer-Lock termination. This type of bag does not comprise valves, unlike bags with a Luer-Lock termination.
As used in the present document, the term “push-fitting means” and its plural refers to conjugate structures which interact by elastic spatial interference. One of the structures resists the passage of the other, forcing the other to move slightly on its vertical axis and/or horizontal axis in order, once introduced into the structure that provides resistance, to return to its position. The terms “push-fitting”, “push-fitting structure” and their plurals and similar terms will be interpreted in accordance with the definition given for “push-fitting means” and its plural.
For a better understanding, the accompanying drawings of an embodiment of the present invention are given as an explanatory but non-limiting example.
The worktop comprises holes 101 for loading medical containers, more specifically for the introduction of the dosing points of medical containers. These holes allow the introduction of supports for any type of medical container such as bags or syringes, or the introduction therein of fixed supports 102, such as universal supports used for different types of medical containers. These fixed supports 102 serve to position the dosing points of medical containers. Alternatively, the worktop may comprise a single hole.
The worktop 100 of the machine comprises a support 200 for attaching the loading device. The worktop may comprise various lines, each with a respective fastening support 200 and holes 101. Multiple lines allow various batches of containers to be filled at the same time. Each fastening support 200 comprises an actuator or retention element 221 and protruding teeth 222 for interconnection with a device for loading medical containers. Said fastening support 200 should be understood as an element of the machine that facilitates the fastening of the device to the rest of the machine.
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The device 3 comprises a rear portion 30 intended to be placed in the support 200 of the worktop 100 of the machine and connection structures 6 between the rear portion 30 and the shaft 1 which gives the device robustness. In the context of this patent, it should be understood in the expression “rear” to the portion which is positioned farthest from the operator once the device or tray is placed in the machine, while the “front” portion is the one that is closest to the operator during the operation of loading bags into the machine. The device also comprises, at the ends thereof, two handles 4 which, in this case, are connected to the rear portion 30 of the device and with the shaft 1. Alternatively, said device might not have handles, or could have walls instead of handles.
The device 3 comprises a lever 2 rigidly connected to the shaft 1, actuation of the lever 2 causing the shaft 1 to rotate. Said lever 2 may be arranged on the right or on the left of the device 3. The handles 4 comprise a housing in the lower portion thereof (not shown) which houses the shaft 1 such that said shaft is rigidly connected to the lever. One of the handles 4 is positioned between the portion of the shaft which comprises the adaptors 5 and the lever 2. The shaft 1 in the example has a cylindrical cross section although, alternatively, the shaft could have other cross sections, such as a cam-type cross section to confer a given trajectory on the bags.
The device 3 of the machine comprises a guide 41 with a curved central or main segment. In the example, the guide is arranged on a handle 4 of the device. The distal ends on the guide 41 define two stops to the rotation of the shaft. The stops define a bag loading position for the operator and an operating position of the machine.
The lever 2 also comprises a protrusion 24 which acts as a through-element. Said protrusion 24 of the lever 2 is situated or housed in the guide 41, so as to pass through said guide. When the lever is actuated, the protrusion 24 travels through the guide 41. Moreover, actuating the lever causes the shaft 1 to rotate. The rotation of the shaft in turn causes the adaptors 5 to rotate conjointly. The guide 41 and the lever 2 are shown positioned on the left portion of the device (seen from the position occupied by the operator during loading). This position is more ergonomic for the operator, although in another position said guide and lever could be on the right of the device.
The device 3 also comprises a cross-piece 8 for supporting the bags of medical product. In the example, the cross-piece is situated on said structures 6. The cross-piece provides support for the bags once the machine is in the operating position. The cross-piece 8 may be moveable and may be extended and retracted. The cross-piece may also comprise grasping areas 81 to make it easier for the operator to push the cross-piece downwards in order to extend and retract said cross-piece.
The device or tray 3 also comprises fastening means to a machine for the preparation of containers of medical products. In the embodiment shown, said fastening means are arranged at the bottom of the rear portion 30 of the device, and comprise protrusions 322 or teeth intended to produce dimensional interference with a protrusion of the attachment support 200 of the machine, claws 35 with an L-shape such that the distal portion of the claw is below the worktop after the device is placed on said worktop, intended to produce dimensional interference with the lower portion of the worktop, preventing the device from moving upwards once the device 3 is placed in the machine, and a groove 321 for the introduction of a retention element 221 of the attachment support 200 of the machine. However, the invention is not limited to these types of attachment means and other known attachment means may also be used.
Once the points of the bags are loaded, the operator presses the pusher 21, moving the protrusion 24 from the end point of the outer segment 410 of the guide to the beginning of the central segment of the guide 41, which in turn compresses the spring 23. Once in the curved central segment of the guide 41, the operator rotates the main body 20 of the lever, which in turn causes the shaft to rotate and in turn the adaptors and the injection points of the bags rotate until positioned in the device operating position. At the same time, the protrusion travels along the central segment of the guide until reaching the other end segment.
To sum up, the device allows easy and uncomplicated loading for the operator, who only has to place the device in the operator bag loading position, once in said position, secure the bags in the adaptors, and then rotate the lever from the operator bag loading position to the machine operating position.
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The adaptor 5 also comprises an anti-rotation system. Accordingly, an area of the adaptor 5 comprises various planar faces 52. These planar faces impede the lateral movement and rotation of the valves or injection points of bags with a Luer-Lock termination once positioned in the housing and push-fitted therein. More specifically, said area of the housing comprises planar faces of a shape conjugate with a transverse cross section of the valve of the bag, so as to prevent movement of the dosing point of the valve of the bag. In the case of bags with no Luer-Lock termination, the adaptor could, for example, have no anti-rotation system and the dosing point could be accessed by the robotic means of the machine using a needle.
The rear portion of the adaptor 5 also comprises a claw 54 which acts as an upper vertical stop which makes it difficult for the valve to be able to leave its position. The valve is placed in the adaptor by introducing the dosing point into the push-fitting means 53 and positioning the valve in the portion that includes the planar faces and the upper vertical stop 54.
Although the invention has been described and illustrated based on representative examples, it should be understood that said embodiment given as an example in no way limits the present invention, and therefore any variations included directly or by equivalence in the content of the accompanying claims, should be considered included within the scope of the present invention.
Number | Date | Country | Kind |
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22382634 | Jul 2022 | EP | regional |
Number | Name | Date | Kind |
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20100017031 | Rob | Jan 2010 | A1 |
20100170206 | Kim | Jul 2010 | A1 |
20190031375 | Miyata | Jan 2019 | A1 |
20210309398 | Kircher | Oct 2021 | A1 |
Number | Date | Country |
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2643119 | Mar 2018 | ES |
20160027466 | Mar 2016 | KR |
Entry |
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Machine translation of KR-20160027466-A (Year: 2016). |
Number | Date | Country | |
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20240002082 A1 | Jan 2024 | US |