ES2586679T3 - Medical device and disposal - Google Patents

Abstract

A medical device (1 ') provided with a needle element (14') and an arrangement (30 ') for use with the medical device (1') to provide clean gas to a receptacle (6 '), the arrangement comprising (30 ') a shield (22') for a tip (23 ') of a needle element (14') of a medical device (1 '), whereby the arrangement (30') comprises a filter (21 ' ) for the filtering of gas to be transferred out of or into the medical device (1 ') through the needle element (14') when the arrangement (30 ') is interconnected with the medical device, and in which the filter (21 ') is integrated with or constitutes at least a portion of the shield (22') of the tip of the needle element, whereby the filter (21 ') is adapted to be placed to cover at least partially or surround the tip ( 23 ') of a needle element of a medical device (1') when the arrangement is interconnected with the medical device (1 '), in which e The medical device (1 ') comprises a connector (2') and a container (3 ') configured to fill with gas that passes through the filter (2 1') before the medical device (1 ') is connected to the receptacle (6 '), in which the container (3') has a variable volume, characterized in that the container (3 ') comprises a first portion (17') made of a relatively rigid material, the first portion of which is coupled to the connector (2 '), and a second portion (18') made of a relatively flexible material attached to the first portion (17 '), thereby making the volume of said variable container

Description

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Medical device and disposition Technical field

The invention relates to a medical device and a provision for use with the medical device.

The invention can be implemented in various medical equipment and used for a number of purposes, but hereinafter, fields of application that constitute a provision used in conjunction with a device for the purpose will be described in particular, but not in any way limited to the invention. aseptic preparation of drugs.

Background of the invention

In the field of drug preparation for injection or infusion, two basic problems generally have to be considered. First, certain demands are made under aseptic conditions to avoid contamination of the drug and, secondly, the drug has to be managed in such a way that drug leaks to the environment are avoided or minimized. By sterile or aseptic manipulation of the drug, the risk for the transfer of bacteria or any other unwanted substance to the patient is reduced. By preventing the leakage of drugs into the environment, the exposure of medical and pharmacological personnel to dangerous drugs is reduced.

To achieve aseptic conditions, safety boxes, cabinets or special insulators are being used where the air is filtered through HEPA filters to avoid contamination during drug preparation. Ventilated cabinets are also used to reduce uncontrolled leakage to the environment and avoid occupational exposure to potentially dangerous drugs. These types of facilities, however, require a large amount of space and are associated with relatively high costs. On the other hand, the protection offered may be insufficient and environmental problems due to accidental exposure to drugs, for example, cytotoxins, have been reported.

Another solution to the problems mentioned above is to create a system called "closed" or "no ventilation" for the handling of drugs during preparation. Such systems exist and allow the preparation to be carried out without the use of clean rooms or special gas cabinets. In this closed system, the drugs are managed isolated from the environment during each stage to avoid contamination of the drug and the unwanted drug leak to the environment.

A known problem associated with the preparation of drug solutions is the fact that medical bottles or vials are usually made of a non-compressible material, such as glass or plastic. To allow the vial to drain, the air has to flow into the vial to avoid negative pressure in the medication vial that otherwise counteracts the negative pressure or further prevents the transpose of liquid from the vial to another receptacle, such Like a syringe

Different systems for providing sterilized or clean gas are described, for example, in WO 00/35517 and WO 02/11794. However, these systems have drawbacks due to the number of manipulations to be performed and / or the special equipment necessary to provide the gas.

Any type of penetration needle is often used within the field of medical devices. For example, hollow needles are used for penetration of a closure (which may be of rubber, for example) that covers an opening of a drug vial. Such injection needles or cannulas can be used to allow the transport of liquid gas or between a drug vial and another receptacle. The expression "piercing element" or "needle" which is used below is understood to also include peaks and similar components for the penetration of this closure to create a channel for the transport of gas or liquid.

A medical device comprising such a needle has drawbacks because the person handling the device can be injured by the needle due to imprudence. In addition, the package that encloses the device can be damaged by the needle during transport and storage of the device. To solve this problem such medical devices may be provided with a shield protection of the needle covering the tip of the needle, whose shield functions as a protection during storage and initial handling of the device.

US 5,102,406 is directed to a clean air tube that provides a constantly renewable source of purified air to be loaded into a medication syringe prior to the use of the syringe for the withdrawal of liquid medication from a multi-dose vial. The tube is equipped with a clean filter membrane, through which the ambient air is filtered when injected into the tube.

The disclosure also describes the sequence of steps to be followed in loading the syringe with clean filtered air.

WO 02/11794 refers to a procedure for aseptic preparation with an injection syringe. The syringe comprises a container for the injection agent and an immovable connection nozzle connected to the

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container. The procedure is based on loading the container with air. The air is forced to pass through an air filter disposed in the connection nozzle. This allows the syringe container to be loaded with aseptic air in a simple and reliable way. The disclosure also refers to devices for performing the procedure, namely. an injection syringe equipped with an air filter in the connection nozzle, a filter unit that can be connected to the connection nozzle of an injection syringe and a system comprising an injection syringe and a separate filter unit.

Document FR 2 850 564 refers to a device and a method for the extemporaneous preparation of an individual amount of sterile treatment fluid that can be compressible, in particular, a treatment gas, said device comprising a rigid cartridge with a valve of output, an administration syringe and a filter type connection / sterilization device. The cartridge simply contains an individual amount of pressure treatment fluid, and the syringe barrel is adapted to contain this individual amount of sterile treatment fluid.

US 6,073,759 discloses a syringe filled with unit dose gas, which is filled with gas and packaged in a gas barrier material before use to increase the shelf life, that is, to minimize leakage of gas and dilution of the contents of the syringe. The syringe is filled with a selected gas and sealed inside a container made of a high gas barrier material. The container is also filled with the selected gas. The material of the container is selected to have a sufficient gas transmission rate to prevent the selected gas from diffusing out of the container into the atmosphere. The volume of gas in the container is greater than the atmospheric pressure to prevent atmospheric contaminants from entering the container and the syringe.

Summary of the invention

An object of the invention is to provide a medical device and a disposition for use with the medical device, the arrangement of which can reduce the total number of components required and / or provide an additional function to a medical device. In particular, the invention aims to provide such an arrangement suitable for use in conjunction with a medical device to provide clean gas in a rational and safe manner during the preparation of medicaments.

In accordance with the invention, the object is achieved by a medical device and an arrangement according to revindication 1.

By providing an arrangement comprising a shield for a needle tip element of a medical device, in which the arrangement comprises a filter, preferably an air particle filter for gas filtration that is transferred out of or into the medical device through the needle element when the arrangement is interconnected with the medical device, and the filter is integrated with or constitutes at least a portion of the needle element tip shield, two important functions are provided in a single component . The tip of the needle element is protected or shielded and the gas can be cleaned using the filter. Therefore, the invention is based on the idea that, by providing a shield of the tip of the needle element with a filter, the two functions can be achieved in a single and the same component.

According to a preferred embodiment of the invention, the shield of the tip of the needle element is principally or totally constituted by the filter. By manufacturing the needle shield from a filter material, a single component that has two functions can be obtained in a very rational way.

Other advantages and advantageous features of the medical device and the arrangement according to the invention are disclosed in the following description and in the remaining dependent claims.

Brief description of the drawings

With reference to the accompanying drawings, a more detailed description of preferred embodiments of the invention follows, cited as examples.

In the drawings:

Figure 1 is a perspective view of a medical device and an arrangement according to the invention,

Figure 1b is a cross-sectional view illustrating a portion of a filter that has a channel for receiving a needle element,

Figure 2 is a view corresponding to Figure 1 illustrating the medical device in another state,

Figure 3 is a perspective view of the device according to Figure 1, where the arrangement according to the invention has been removed from the medical device,

Figure 4 is an exploded view corresponding to Figure 3,

Figure 5 is a partially sectioned view illustrating a variant of the arrangement according to the

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invention.

Detailed description of preferred embodiments of the invention

In Figures 1 and 2, a medical device l 'for providing clean gas, for example, air, to a receptacle and thereby facilitating the conduction of a substance out of the receptacle is illustrated. Said substance may be various solutions and liquids that constitute drugs, for example, cytotoxic or antibiotic drugs, for use in the medical field. The device comprises a connector 2 'and a container 3 ‘that can form an integrated unit 4'. The connector 2 'is provided with first means 5' for connection to a receptacle 6 'or, in other words, to a first portion of connector 5'. See also Figure 3, which illustrates the device connected to a medicine bottle or vial 6 ', and the exploded view in Figure 4.

The first connection means 5 'may be designed for connection to a bottle, such as the neck of a vial. In the embodiment illustrated in Figures 1 to 4, the first connection means 5 'are constituted by a ring-shaped portion 7' to enclose the neck 8 'of a vial 6'. The ring-shaped portion 7 'has openings 9' to form flanges 10 'projecting downward. The flanges 10 'may be provided with hooks 11' or prongs to be held around the neck 8 'of the vial 6'. The connector 2 'is suitably provided with second means 12' for connection to a transfer element 13 '(illustrated in Figures 3 and 4), such as an injector device for interconnecting with the connector, for transporting a substance outside receptacle 6 ', or in other words; connector 2 is conveniently provided with a second portion of connector 12 '.

In another embodiment, the second connection means 12 'may comprise a luer lock coupling or bayonet coupling (not shown) to allow an injection device to be connected. The injector device and the connector are suitably provided with a membrane to create a double membrane coupling between the injector and the current device.

The connector 2 'is preferably provided with a piercing element, such as a hollow needle 14' (as illustrated) for the penetration of a closure (not illustrated) made of rubber, for example, whose closure covers the opening of a container 6, such as a vial. In addition to the injection needles or cannulas, the expression "needle" is intended to comprise peaks and similar components for the penetration of this closure to create a channel for the transport of gas. In this document, a channel is created between the container 3 'and the receptacle 6' to which the connector 2 'is connected. Through a channel or passage 15 'of the needle 14', the gas contained in the container 3 'can be transferred from the container to the receptacle 6', that is, the gas can flow from the container 3 'to the receptacle 6'.

The connector 2 ‘and the container 3‘ can form an integrated unit 4 '. This implies that the connector and the container are made in one piece or the connector 2 'and the container 3 ‘can be coupled together to form an integral unit. For this reason, the different types of coupling means 16 'known from the prior art can be used as long as a hermetic connection, or at least substantially air tight connection, between the current components 2', 3 'can be obtained.

The container 3 ‘must be filled with gas before connecting the connector 2 'to a receptacle 6'. The volume of the container 3 variable is variable. To obtain a container 3 'having a variable volume, the container comprises a first portion 17' made of a relatively rigid material, whose first portion is coupled to the connector 2 ', and a second portion 18' made of a relatively flexible material joined to the first portion 17 '. The second portion 18 'can be extensible by manipulating, for example, a handle 20' disposed at the end of the container 3 ‘. Hereby, the volume of the container 3 'can be increased and decreased, respectively. For example, the container 3 'can be designed as a bellows that is compressible and extensible, affecting the container manually. The container 3 'is preferably provided with said handle 20' to regulate the volume of the container 3 '. Although the volume of the container is variable as illustrated, there may be other ways to fill the container and at the same time ensure that the gas passes to a filter 21 '. For example, the gas container could consist of a sealed flexible bag vacuum packed, the seal of which can be broken to allow gas to flow into the bag.

The amount of gas, preferably air, provided by the previously filled container, must be adapted to the volume of the container to be drained. The volume of the gas when it is in the receptacle should preferably correspond to the volume of the container so that the receptacle drains completely. This implies that the volume of the gas cleaned or sterilized in the previously filled container is preferably more or less equal to or greater than the volume of the container, provided that the gas pressure is substantially the same in the receptacle and in the container. For most medicine bottles or vials, the volume of the gas should be in the range of 1 to 100 cm 3 at atmospheric pressure.

By the expression "clean" gas it is understood that the gas has been filtered by a filter, such as an air particle filter to remove viable particles and / or microorganisms to such an extent that the gas is classified to be aseptic and accepted. by the competent authority and / or any standard. The degree of purity can be expressed in the largest particles that can pass the filter for a given gas flow rate. In some cases, none or very few particles that have a size greater than 5 IJm are allowed to be present in the gas

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cleansed. However, the allowed particle size is determined by the requirements of the current application. Some drug treatments require that substantially all particles having a size greater than 0.15 IJm be removed from the gas by the air particle filter. As an example, a filter with a mesh size of 0.2 IJm can be used to substantially eliminate all particles and microorganisms of that size.

The arrangement 30 'and the medical device l' are interconnected with each other. In the embodiment mode illustrated in Figure 1, the arrangement comprises a shield 22 'to cover the tip 23' of a needle element 14 'of the medical device 1'. According to the invention, a filter 21 'is integrated with or constitutes at least a portion of the shield 22' of the tip of the needle element. In the illustrated embodiment, the filter is arranged to filter the gas that is transferred to the medical device through the needle element 14 '. The filter 21 'is preferably an air particle filter, for the cleaning of gas, such as air that is transferred in the medical device through the needle element 14'. In this example, the shield 22 'of the needle element comprises a support or a frame 24' for the housing of the filter 21 ', hereafter referred to as an air particle filter, the frame 24' of which can be connected to the medical device 1 ', that is, to connector 2'. The main portion of the shield 22 'of the needle element is suitably constituted by the filter 21' of air particles which is arranged for cleaning the gas that is transported from the environment to the container 3 '. In other words; The air particle filter 21 'is arranged to clean the gas passing through the air particle filter 21' during filling of the container 3 'with gas (increasing the volume of the container 3') before the connection of the connector 2 'to a receptacle 6'. In accordance with the invention, the filter is integrated with or constitutes at least a portion of the shield of the needle element tip. The terms "integrated with" and "constitutes at least a portion of" are intended to comprise an arrangement in which the filter is releasably or permanently connected to the shield of the needle element tip, or is made in a single piece with the shield, as well as embodiments in which the filter itself constitutes a portion or the whole shield of the needle element. In addition, in another embodiment of the invention, the arrangement could comprise two or more filters.

The shield of the needle element tip is adapted to be arranged to at least partially cover or surround the tip of a needle element of a medical device when the arrangement is interconnected with the medical device. This implies that the shield of the needle element tip covers the tip in at least one direction to prevent a user of the arrangement from being injured with the needle due to imprudence. For example, the shield may be arranged immediately in front of the tip, so that it covers the tip in the longitudinal direction of the needle element. The shield may also be designed as a tube or as a part or parts of a tube, which surrounds the tip of the needle. This shield rather covers the tip in a direction substantially perpendicular to the longitudinal direction of the needle element, but extends beyond the tip in the longitudinal direction of the needle and out of the needle element to avoid contact with the tip of the needle element also in the longitudinal direction.

The air particle filter 21 'is preferably adapted to be placed in front of the tip 23' of the needle element 14 'and to cover at least partially or surround the tip of the needle element 14' of the medical device when the arrangement is interconnected With the medical device. As already described, the air particle filter 21 'can be arranged in a frame or support 24' or the like, which in turn fits the connector 2 '. Also, alternatively or in combination, the air particulate filter 21 'itself can be designed to engage with the connector 2' and / or with the needle element 14 ', or the air particle filter 21', can be partially penetrated by the needle element 14 'to keep the air particle filter 21' in position. Therefore, in an embodiment of the invention, the air particle filter 21 'is adapted to be placed to enclose the tip 23' of the needle element 14 'of the medical device X when the arrangement 30' is interconnected with the 1 'medical device.

Instead of being partially penetrated by the needle 14 ', the air particle filter 21' may be provided with a channel 31 '(illustrated in Figure 1b) to receive the tip 23' of the needle element 14 'therein . In both cases, the air particle filter 21 'preferably encloses the tip 23' of the needle element tightly to avoid transporting gas into or out of the needle element 14 'without passing through the air particle filter 21'.

According to a preferred embodiment of the invention, the air particulate filter 21 'is designed and arranged as a protection portion of the shield 22' of the needle element. This implies that the air particle filter 21 'cleans the gas and, at the same time, the air particle filter 21' functions as a protection during the manipulation of the device 1 ', since the air particle filter 21' , at least partially cover or surround the tip 23 'of the needle 14'. In addition, the shield 22 ’of the tip of the needle element protects the sterile container that encloses the device during transport and storage of the device.

The air particle filter 21 'is preferably arranged to bump against the tip 23' of the needle element, or rather in immediate contact with the needle portion having an opening 32 'for the transport of fluid into or out of the needle element 14 '. By covering the opening 32 'of the needle 14' by means of the air particle filter 21 ', it is ensured that the gas carried in the container 3' has to pass the air particle filter 21 '. The arrangement and, therefore, the shield 22 'of the tip of the needle element is preferably adapted to be removably placed in a medical device 1'. In the illustrated examples, the shield 22 'of the needle element is removed prior to the connection of the medical device l' to a vial 6 ', as described further below. The arrangement 30 'according to the invention, and, therefore, the particulate filter

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of air 21 'is arranged to be removed from the integrated unit 4' after the container 3 'has been filled with clean gas. After filling the container 3 ', the air particle filter 21' is removed and the connector 2 'is connected to the receptacle 6'. When removing the air particle filter 21 ', after the container 3' has been filled with the gas and before the interconnection of the connector 2 'and the receptacle 6' with each other, any contamination particles removed from the gas and collected in the air particle filter 21 'they are removed from the integrated unit 4'. Therefore, one and the same channel 15 'can be used to fill the container 3' with clean gas and to transfer the clean gas from the container 3 'to a receptacle 6'.

A variant of the arrangement 30 'according to the invention is illustrated in Figure 5. The air particle filter 21 'is arranged in a frame 24' that is connected to a medical device and the air particle filter 21 'covers the tip 23' of the needle element. According to an embodiment of the invention illustrated in Figure 5, where the air particle filter 21 'does not enclose the tip 23' of the needle element, but is arranged somewhat apart from the tip 23 'of the element of needle, the arrangement 30 'can preferably be connected to the medical device, for example, to the connector 2', to obtain a substantially hermetic connection between the medical device and the shield 22 'of the needle. This implies a limited space 35 ', whose space 35' is sealed with respect to the environment, creating around the tip 23 'of a needle element 14' of the medical device, which allows the transport of gas between the space 35 ' and the environment only through the air filter 21 '.

Cover means, for example, a cover (not illustrated) may be arranged to cover the air particle filter, preferably in a hermetic manner. The lid may have the function of preventing the transport of liquid, gas or any vapor in the direction from the medical device to the environment or in the opposite direction, that is, in the medical device from the environment, to counteract that any substance Unwanted in the receptacle is escaped into the environment or introduced into the medical device, respectively.

A lid of this type can be used to prevent further communication between the inside of the medical device and the environment through the air particle filter after the container has been filled. The container can be filled with clean gas and then the lid is mounted to cover the air particulate filter and prevent additional transport of gas through the air particle filter. Then, the arrangement can be removed from the medical device and the connector and receptacle can be interconnected, and subsequent manipulations can be performed safely.

It should be understood that the present invention is not limited to the embodiments described above and illustrated in the drawings; rather, the person skilled in the art will recognize that many changes and modifications can be made within the scope of the appended claims.

Claims (14)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 1. A medical device (1 ') provided with a needle element (14') and a disposition (30 ') for use with the medical device (1') to provide clean gas to a receptacle (6 '), comprising the arrangement (30 ') a shield (22') for a tip (23 ') of a needle element (14') of a medical device (1 '), whereby the arrangement (30') comprises a filter ( 21 ') for gas filtration to be transferred out of or into the medical device (1') through the needle element (14 ') when the arrangement (30') is interconnected with the medical device, and in which the filter (21 ') is integrated with or constitutes at least a portion of the shield (22') of the tip of the needle element, whereby the filter (21 ') is adapted to be placed to cover at least partially or surround the tip (23 ') of a needle element of a medical device (1') when the arrangement is interconnected with the medical device (1 '), in which the medical device (1' ) comprises a connector (2 ') and a container (3') configured to fill with gas that is passed through the filter (21 ') before the medical device (1') is connected to the receptacle (6 '), wherein the container (3 ') has a variable volume, characterized in that the container (3') comprises a first portion (17 ') made of a relatively rigid material, whose first portion is coupled to the connector (2'), and a second portion (18 ') made of a relatively flexible material bonded to the first portion (17'), thereby making the volume of said variable container. 2. A medical device (1 ') and an arrangement (30') according to claim 1, characterized in that the filter (21 ') is adapted to be placed to cover an opening (32') of a needle element (14 ') of the medical device (1') when the arrangement is interconnected with the medical device. 3. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized because the filter (21 ') is adapted to be placed to enclose the tip (23') of a needle element (14 ') of the medical device (1') when the arrangement is interconnected with the medical device. 4. A medical device (1 ') and an arrangement (30') according to claim 3, characterized in that the filter (21 ') is adapted to be partially penetrated by the tip (23') of the needle element (14 '). 5. A medical device (1 ') and an arrangement (30') according to claim 3, characterized in that the filter (21 ') is provided with a channel (31') to receive the tip (23 ') of the element needle (14 '). 6. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized because the filter (21 ') is adapted to be placed in front of the tip (23') of a needle element (14 ') of the medical device (1') when the arrangement is interconnected with the medical device. 7. A medical device (1 ') and an arrangement (30') according to any previous claim, characterized in that the shield (22 ') of the tip of the needle element is principally or completely constituted by the filter (21') . 8. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized in that the arrangement (30 ') is adapted to be detachably placed in the medical device (1'). 9. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized because the arrangement (30 ') is adapted to connect to the medical device (1') to obtain a substantially hermetic connection between the medical device and the arrangement. 10. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized in that the filter (21 ') is an air particle filter. 11. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized in that the arrangement (30 ') comprises a frame (24') for housing the filter (21 '), whose frame It can be connected to the medical device (1 '). 12. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized in that the arrangement (30 ') is disposed removably on the medical device (1'). 13. A medical device (1 ') and an arrangement (30') according to any preceding claim, characterized in that the arrangement (30 ') is arranged in the medical device (1') to obtain a substantially hermetic connection between the device Doctor and disposition. 14. A medical device and an arrangement (30 ') according to any preceding claim, characterized in that the medical device (1') is a device to be used in the preparation of medicaments. \ image 1 Fig. L Fig.lb