JP5026590B2 - Mounting tool for use with medical devices - Google Patents

Description

The invention relates to a fixture for use with a medical device according to the premise of claim 1 and to a medical device according to the premise of claim 14.
The present invention can be implemented in a variety of medical devices and can be used for a number of purposes, but will hereinafter be a specific, non-limiting application field that constitutes a fixture for use with a device for aseptic preparation of drugs. Will be described.

  In the field of injection or infusion preparation, two basic issues generally need to be considered. First, to avoid drug contamination, certain demands on sterility arise, and second, the drug needs to be handled to prevent or minimize leakage of the drug to the environment. By handling the drug in a sterile or aseptic condition, the risk of transferring bacteria or other undesirable substances to the patient is reduced. By preventing drug leakage to the surroundings, medical and pharmacological personnel are less exposed to harmful drugs.

  To achieve aseptic conditions, special safety boxes, cabinets, or isolators in which air is filtered through HEPA filters are used to prevent contamination during dispensing. Ventilation cabinets are also used to reduce uncontrolled leakage to the surroundings and prevent occupational exposure to potentially harmful drugs.

However, such equipment requires a lot of space and leads to a relatively high cost. Furthermore, the protection provided may be inadequate, and work environment problems have been reported due to inadvertent exposure to drugs, eg, cytotoxins.

  Another solution to the problem described above is to create a so-called “closed” or “non-vented” system for handling the drug during preparation. Such systems exist and make it possible to achieve preparation without the use of special clean rooms or fume hoods. In such a closed system, the drug is handled isolated from the surroundings throughout all steps to avoid drug contamination and unwanted drug leakage to the environment.

  A known problem associated with dispensing solutions is usually the fact that medical bottles or vials are made of incompressible materials such as glass or plastic. Emptying the vial requires air to flow into the vial to avoid negative pressure in the drug vial; otherwise, the negative pressure will cause another receptacle, such as a syringe, from the vial. Further movement of the liquid is inhibited or prevented.

  Various systems for providing sterilized or clean gas are described, for example, in WO00 / 35517 and WO02 / 11794. However, such systems have the disadvantage that the number of operations that must be performed and / or special equipment for supplying the gas is required.

  In the field of medical devices, very often some kind of puncture needle is used. For example, a hollow needle is used to penetrate a closure (eg, made of rubber) that covers the opening of the drug vial. Such a needle or cannula can be used to allow gas or liquid transport between the drug vial and another receptacle. As used herein, the expression “puncture member” or “needle” is intended to include spikes and similar components that penetrate these closures to form a gas or liquid transport path.

  A medical device having such a needle has the disadvantage that a person handling the device is inadvertently injured by the needle. Furthermore, the package enclosing the device may be damaged by the needle during transport and storage of the device. In order to solve this problem, such medical devices may be provided with a needle shield that covers the tip of the needle, and such shield serves as a protector during storage or initial handling of the device.

  It is an object of the present invention to provide a fitting for use with a medical device that can reduce the total number of required components and / or provide additional functionality to the medical device. In particular, the present invention seeks to provide such a fitting that is suitable for use with a medical device to provide a clean gas in a rational and safe manner during dispensing.

According to the invention, the object is achieved by a fixture according to claim 1.
A fixture having a shield for the tip of a needle member of a medical device, and when the fixture is interconnected with the medical device, filters the gas to be transferred to or from the medical device via the needle member Providing a fitting, preferably a particulate air filter, wherein the filter is integral with, or at least forms part of, the needle member tip shield, so that two important functions can be achieved in a single component. Provided. The needle member tip is protected or shielded and the gas can be cleaned using a filter. Accordingly, the present invention is based on the insight that by providing a needle member tip shield with a filter, two functions can be achieved in a single, identical component.

According to a preferred embodiment of the present invention, the needle member tip shield is mainly constituted by a filter. By manufacturing the needle shield with filter material, a single component with two functions can be obtained in a very reasonable way.
Other advantages and advantageous features of the fixture according to the invention are disclosed in the following description and in the dependent claims.
The invention further relates to a medical device provided with a needle member and a fitting according to the invention.

It is a perspective view which shows a medical device provided with the fixture by this invention. It is sectional drawing which shows a part of filter which has a channel which accommodates a needle member. FIG. 2 is a view corresponding to FIG. 1 showing the medical device in another state. 2 is a perspective view of the device according to FIG. 1 with the fitting according to the invention removed from the medical device. FIG. 4 is an exploded view corresponding to FIG. 3. It is a fragmentary sectional view which shows the deformation | transformation of the fixture by this invention.

  Preferred embodiments of the present invention will be described below in more detail with reference to the accompanying drawings.

  FIGS. 1 and 2 illustrate a medical device 1 ′ that facilitates transport of a substance from the receptacle by providing a clean gas, such as air, to the receptacle. Such materials may be various solutions and liquids that make up drugs used in the medical field, such as cytotoxic drugs and antibiotics. The apparatus comprises a connector 2 'and a container 3' that can form an integral unit 4 '. The connector 2 'is provided with a first means 5' for connecting to the receptacle 6 ', in other words, a first connector portion 5'. See also the exploded view of FIG. 3 and FIG. 4 showing the device connected to a medical bottle or vial 6 '.

  The first connecting means 5 'can be designed to connect to a bottle, such as the neck of a vial. In the embodiment shown in FIGS. 1 to 4, the first connecting means 5 ′ is constituted by an annular portion 7 ′ that surrounds the neck 8 ′ of the vial 6 ′. The ring-shaped portion 7 'has a slit 9' so that a flange 10 'protruding downward is formed. The flange 10 'can be provided with a hook 11' or barb for gripping around the neck 8 'of the vial 6'. The connector 2 ′ has a second means 12 for connection with a transfer member 13 ′ (shown in FIGS. 3 and 4), such as a syringe, to be interconnected with the connector for transport of material from the receptacle 6 ′. 'Is appropriately provided, in other words, the connector 2' is appropriately provided with the second connector portion 12 '.

  In another embodiment, the second connecting means 12 'can comprise a luer lock coupling or bayonet coupling (not shown) so that a syringe can be connected. Both the syringe and the connector are suitably provided with a membrane to form a double membrane bond between the syringe and the target device.

  The connector 2 ′ is preferably provided with a puncture member such as a hollow needle 14 ′ (not shown) that penetrates a rubber closure (not shown), for example, and the closure is a receptacle 6 ′ such as a vial. Cover the opening. In addition to infusion needles or cannulas, the expression “needle” is intended to include spikes and similar components that penetrate these closures to form a gas transport path. Here, a flow path is formed between the container 3 ′ and the receptacle 6 ′ connecting the connector 2 ′. The flow path or passage 15 'of the needle 14' allows the gas contained in the container 3 'to move from the container to the receptacle 6', i.e., allows the gas to flow from the container 3 'to the receptacle 6'.

  Connector 2 'and container 3' may form an integral unit 4 '. This means that the connector and container can be made as one piece, or the connector 2 'and container 3' can be coupled together to form an integral unit. For this reason, various types of coupling means known from the prior art can be used as long as an airtight or at least substantially airtight connection is obtained between the components 2 ', 3'.

  The container 3 'needs to be filled with gas before connecting the connector 2' to the receptacle 6 '. The volume of the container 3 'is preferably variable. In order to obtain a container 3 ′ having a variable volume, the container is made of a relatively hard material and is made of a relatively soft material and a first part 17 ′ coupled to the connector 2 ′. And a second portion 18 'attached to 17'. The second portion 18 'can be made expandable, for example, by manipulating a handle 20' disposed at the end of the container 3 '. As a result, the volume of the container 3 'can be increased or decreased. For example, the container 3 'can be a bellows that can be manually compressed and expanded into the container. The container 3 'is preferably provided with a handle 20' for adjusting the volume of the container 3 '.

  The volume of the container is preferably variable as shown, but there are other ways to fill the container and at the same time ensure that the gas passes through the filter 21 '. For example, the gas container can be composed of a sealed vacuum-packed soft bag that can be sealed to allow gas to flow into the bag. Alternatively, the gas container is rigid or semi-rigid and uses pressurized gas to fill the container.

The amount of gas, preferably air, supplied by the prefilled container should be suitable for the volume of the receptacle to be emptied. The volume of gas when present in the receptacle should preferably correspond to the volume of the receptacle so that the receptacle can be completely emptied. This is because if the gas pressure is substantially the same in the receptacle and in the container, the volume of clean or sterile gas in the pre-filled container is preferably approximately equal to or greater than the volume of the receptacle. It means that there is. For most medical bottles or vials, the gas volume should be between 1 and 100 cm ^{3 at} atmospheric pressure.

  The expression “clean” gas means that the particulate and / or living microorganisms are to the extent that the gas is filtered through a filter, such as a particulate air filter, and the gas is classified as sterile and is recognized by the relevant authorities and / or any criteria. Means that it has been removed. Cleanliness can be expressed as the largest particle that can pass through the filter for a constant gas flow rate. In some cases, particles having a size greater than 5 μm are tolerated in the clean gas with little or no presence. However, the acceptable particle size is determined by the requirements of the intended application. In the handling of some drugs, particles having a size greater than 0.15 μm need to be substantially all removed from the gas by a particulate air filter. As an example, a filter having a mesh size of 0.2 μm can be used to remove substantially all particles and microorganisms of that size.

  Furthermore, the medical device 1 'is provided with a fixture 30' according to the present invention. The fixture 30 'and the medical device 1' are interconnected with each other. In the embodiment shown in FIG. 1, the fixture comprises a shield 22 'for covering the tip 23' of the needle member 14 'of the medical device 1'. According to the present invention, the filter 21 'is integrated with or at least part of the needle member tip shield 22'. In the illustrated embodiment, the filter is arranged to filter the gas that is to be transferred to the medical device via the needle member 14 '. The filter 21 ′ is preferably a particulate air filter that cleans a gas such as air to be transferred to the medical device via the needle member 14 ′.

  In this example, the needle member shield 22 ′ comprises a holder or frame 24 ′ for accommodating a filter 21 ′, hereinafter referred to as a particulate air filter, which is attached to the medical device 1 ′, ie the connector 2 ′. Connectable. The main part of the needle member shield 22 'is suitably constituted by a particulate air filter 21' arranged to clean the gas to be transported from the surroundings to the container 3 '. In other words, the particulate air filter 21 ′ is used to fill the container 3 ′ with gas (by increasing the volume of the container 3 ′) before connecting the connector 2 ′ to the receptacle 6 ′. Is arranged to clean the gas passing through.

  According to the present invention, the filter is integrated with or constitutes a part of the needle member tip shield. The expressions “integrate” and “constitute at least part” refer to an arrangement in which the filter is removable or permanently connected to the needle tip shield, or an arrangement that is made as one piece with the shield, and the filter itself. Includes an embodiment that constitutes part or all of the needle member tip shield. Furthermore, in other embodiments of the present invention, the fixture may comprise more than one filter.

  In a preferred embodiment of the present invention, the needle member tip shield is arranged to at least partially cover or surround the tip of the needle member of the medical device when the fitting is interconnected to the medical device. Suitable for. This means that the needle member tip shield covers the tip in at least one direction in order to avoid inadvertent injury of the fixture user by the needle.

  For example, the shield can be disposed immediately before the tip so as to cover the tip in the longitudinal direction of the needle member. The shield can also be designed as a tube or part or portions of the tube surrounding the needle tip. Such a shield covers the tip in a direction substantially perpendicular to the longitudinal direction of the needle member, but the tip in the longitudinal direction of the needle also prevents contact with the needle member tip in the longitudinal direction. It extends beyond the part and away from the needle member.

  The particulate air filter 21 ′ is preferably disposed in front of the tip 23 ′ of the needle member 14 ′ and when the fitting is interconnected with the medical device, of the needle member 14 ′ of the medical device. The tip is at least partially covered or surrounded. As described above, the particulate air filter 21 'may be further disposed within a frame or holder 24' or the like attached to the connector 2 '. Furthermore, the particulate air filter 21 ′ itself can be designed to engage with the connector 2 ′ and / or the needle member 14 ′ instead or in combination, or the particulate air filter 21 ′ is held in place. Thus, it is possible to partially penetrate the particulate air filter 21 ′ by the needle member 14 ′. Thus, in one embodiment of the present invention, the particulate air filter 21 ′ has a distal end 23 ′ of the needle member 14 ′ of the medical device 1 ′ when the fixture 30 ′ is interconnected with the medical device 1 ′. It is arranged to wrap up.

  Instead of being partially penetrated by the needle 14 ', the particulate air filter 21' can be provided with a channel 31 '(shown in FIG. 1b) that houses the tip 23' of the needle member 14 'therein. In any case, in order to prevent gas from being transported into or out of the needle member 14 ′ without passing through the particulate air filter 21 ′, the particulate air filter 21 ′ has a tip 23 ′ of the needle member. Enclose tightly.

  According to a preferred embodiment of the present invention, the particulate air filter 21 'is designed and arranged as a protection for the needle member shield 22'. This is because the particulate air filter 21 ′ at least partially covers or surrounds the tip 23 ′ of the needle 14 ′, so that the particulate air filter 21 ′ cleans the gas and at the same time the particulate air filter 21 ′ is the device 1 ′. It means that it functions as a protective part during handling. Furthermore, the needle member tip shield 22 'protects the sterile package enclosing the device during transport or storage of the device.

  The particulate air filter 21 ′ is preferably in contact with the needle member tip 23 ′ or, strictly speaking, directly on the portion of the needle having an opening 32 ′ for fluid transport into or out of the needle member 14 ′. Placed in contact. By covering the opening 32 'of the needle 14' with the particulate air filter 21 ', it is ensured that the gas placed in the container 3' must pass through the particulate air filter 21 '.

  In this manner, the attachment member is configured such that the needle member tip shield 22 'is detachably disposed on the medical device 1'. In the illustrated example, the needle member shield 22 'is removed prior to connection with the vial 6' of the medical device 1 ', as further described below. The fixture 30 ′ according to the present invention is arranged such that the particulate air filter 21 ′ is removed from the integrated unit 4 ′ after the container 3 ′ is filled with clean gas. Following filling of the container 3 ', the particulate air filter 21' is removed and then the connector 2 'is connected to the receptacle 6'.

  After the container 3 ′ is filled with gas, the particulate air filter 21 ′ is removed prior to interconnection with the connector 2 ′ and the receptacle 6 ′, thereby removing any air collected from the gas and collected in the particulate air filter 21 ′. The contaminating particles are removed from the integrated unit 4 ′. In this way, one and the same flow path 15 'can be used both for filling the container 3' with clean gas and for transferring clean gas from the container 3 'to the receptacle 6'.

  FIG. 5 shows a variation of the fixture 30 'according to the present invention. The particulate air filter 21 ′ is disposed in the frame 24 ′ to be connected to the medical device, and the particulate air filter 21 ′ covers the needle member tip portion 23 ′. According to such an embodiment of the invention shown in FIG. 5 in which the particulate air filter 21 ′ does not surround the needle member tip 23 ′ and is spaced somewhat from the needle member tip 23 ′, the fixture 30. 'Can preferably be connected to a medical device, for example a connector 2', so that a substantially airtight connection is obtained between the medical device and the needle member shield 22 '. This is because a limited space 35 ′, which is blocked from the surroundings, is formed around the distal end 23 ′ of the needle member 14 ′ of the medical device, so that the space 35 ′ and the surroundings are separated only through the particulate air filter 21 ′. Means that gas can be moved between the two.

  Cover means, for example a lid (not shown), can be provided to cover the particulate air filter, preferably in an airtight manner. The lid is directed from the medical device toward the environment, or in the opposite direction, i.e., from the periphery into the medical device, to prevent any undesirable material in the receptacle from escaping to the environment or being introduced into the medical device. It has the function of preventing the movement of liquid, gas or some vapor in the direction.

  Such a lid can be used to prevent further communication between the interior of the medical device and the surrounding environment via the particulate air filter after filling the container. The container can be filled with clean gas, after which a lid is attached to cover the particulate air filter to prevent further gas transport through the particulate air filter. The fixture can then be removed from the medical device and connector and the receptacle can be interconnected so that subsequent operations can be performed safely.

  It will be appreciated that the invention is not limited to the embodiments described above and shown in the drawings, but rather, those skilled in the art will recognize that numerous modifications and variations may be made within the scope of the appended claims.

Claims (18)

A fitting (30 ') for use with a medical device, comprising a shield (22') for the tip (23 ') of the needle member (14') of the medical device (1 '), the fitting (30 A filter (21 ′) for filtering the gas to be transferred to the outside or inside of the medical device (1 ′) via the needle member (14 ′) when ') is interconnected with the medical device wherein the filter (21 '), the needle member tip shield (22') and either integral, or constitutes at least a part thereof, the container (3 '), the medical device is a receptacle A fixture characterized by being configured to be filled with gas that passes through the filter (21 ') while not connected .   The needle member tip shield (22 ') is arranged to at least partially cover or surround the tip (23') of the needle member of the medical device when the fixture is interconnected with the medical device. The fixture according to claim 1, wherein:   The filter (21 ′) at least partially covers the tip (23 ′) of the needle member (14 ′) of the medical device (1 ′) when the fixture is interconnected with the medical device; The fixture according to claim 1, wherein the fixture is arranged so as to surround. The filter (21 ′) is arranged to cover the opening (32 ′) of the needle member (14 ′) of the medical device (1 ′) when the fitting is interconnected with the medical device. The fixture according to any one of claims 1 to 3, wherein The filter (21 ′) is arranged to wrap around the tip (23 ′) of the needle member (14 ′) of the medical device (1 ′) when the fitting is interconnected with the medical device. The fixture according to any one of claims 1 to 4, wherein:   6. A fitting according to claim 5, characterized in that the filter (21 ') is partially penetrated by the tip (23') of the needle member (14 ').   6. A fitting according to claim 5, characterized in that the filter (21 ') is provided with a channel (31') for receiving the tip (23 ') of the needle member (14'). The filter (21 ′) is disposed in front of the tip (23 ′) of the needle member (14 ′) of the medical device (1 ′) when the fitting is interconnected with the medical device. The fixture according to any one of claims 1 to 7, wherein The needle member tip shield (22 ') is mainly or completely the filter (21', characterized in that it is constituted by a) fitting according to any one of claims 1 to 8. 10. A fitting according to any one of the preceding claims , characterized in that the fitting (30 ') is detachably arranged on the medical device (1'). The fitting (30 ') is connected to a medical device (1') so that a substantially airtight connection is obtained between the medical device and the fitting . The fixture according to any one of 10 . The fixture according to any one of claims 1 to 11 , characterized in that the filter is a particulate air filter (21 '). The attachment (30 ') comprises a frame (24') for accommodating the filter (21 ') connectable to a medical device (1'), according to claim 1-12. The fixture according to any one of the above.   A medical device (1 ') provided with a needle member (14') and a fitting (30 ') according to any of claims 1-13.   The medical device (1 ') according to claim 14, characterized in that the fitting (30') is detachably arranged on the medical device (1 ').   15. A device according to claim 14, characterized in that the fitting (30 ') is arranged on the medical device (1') so that a substantially airtight connection is obtained between the medical device and the fitting. 15. The medical device (1 ′) according to 15.   The medical device according to any one of claims 14 to 16, characterized in that the medical device (1 ') is a device for supplying clean gas to the receptacle (6').   The medical device according to any of claims 14 to 17, characterized in that the medical device (1 ') is a device used in dispensing.