Sterile container and filter unit for a sterile container

ES 2 290 451 T3

DESCRIPTION

Sterile container and filter unit for a sterile container.

The invention relates to a filter unit for a sterile container, especially for the accommodation and sterile storage of instruments or surgical material, comprising a housing container, a lid for closing the housing container and a gas exchange opening closable by the filter unit, the filter unit comprising a sterile filter held by at least one support member, the filter unit presenting at least one gripping area separate from the sterile filter for gripping and holding the filter unit, and the gripping area comprising a gripping surface, the at least one support element comprising a first external holding frame, the sterile filter being attached to the external holding frame, the at least one support member comprising a second internal holding frame, and the internal clamping frame being arranged within the first external clamping frame, and being attached thereto by means of attachment elements.

Furthermore, the present invention relates to a sterile container, especially for the accommodation and sterile preservation of surgical instruments or material, comprising a housing space formed by a container base and container walls, a lid to close the storage space. housing and a gas exchange opening which can be closed by a filter unit.

In sterile containers of this type, instruments or surgical material are sterilized and housed, for example. In order for hot steam to enter the sterile container during the sterilization operation, a gas exchange opening is required. However, to prevent germs, bacteria or the like from entering the sterile container after sterilization, the gas exchange opening is already closed before the sterilization operation with a sterile filter, which allows gas exchange, but does not allow penetrate any unwanted pathogens into the sterile container.

When exchanging the filter units in the sterile container, it has proved disadvantageous that, in the case of a not very careful procedure when exchanging the sterile filter, it can come into contact with the fingers and thus can get dirty.

From US 5,736,043 filter units are known which have gripping areas arranged on a support element, which protrude radially outwards.

Therefore, the object of the present invention is to improve a filter unit and a sterile container of the type described at the beginning so as to increase the stability of the filter unit.

This object is achieved according to the invention with a filter unit of the type described at the beginning, because the sterile filter is arranged between two of the mentioned support elements and because the connection elements of the two support elements connected to each other are arranged rotated. with respect to each other around an axis of rotation oriented parallel to a direction perpendicular to a plane defined by the sterile filter.

By means of the separate gripping area of ​​the sterile filter it is possible for a person during the exchange to grasp and hold the filter unit in the specially provided gripping area. In this way the filter unit can be safely grasped in the grip area, thus avoiding the danger of the person slipping their fingers over the sterile filter and making it dirty. In order to form a passage surface through the sterile filter as large as possible, while guaranteeing a secure and stable fixation of the sterile filter, it is provided that the at least one support element comprises a first external holding frame, and that the sterile filter is attached to the external holding frame. It is favorable that the at least one supporting element comprises a second internal clamping frame, and that the internal clamping frame is arranged within the first external clamping frame and is connected to it by means of connecting elements. In particular, in the case of highly flexible, thin or particularly sensitive sterile filters, the sterile filter is additionally stabilized by this special configuration. However, it is also advantageous if the connecting elements of the two supporting elements connected to one another are arranged rotated relative to each other about a rotational axis oriented parallel to a direction perpendicular to a plane defined by the sterile filter. Although the passage area through the sterile filter is slightly reduced as a result, the stability of the filter unit is nonetheless increased, since in the event of an inadvertent slippage of a finger when holding the filter unit, the sterile filter it cannot be traversed so easily. The connecting elements form barriers that cannot be damaged by fingers.

Preferably, the at least one gripping zone is arranged on the at least one support element. This increases the stability of the filter unit, especially the support elements and the gripping area can be configured in one piece.

It is favorable when the at least one gripping area comprises a recess arranged in the at least one support element. If an operator grasps the filter unit by the grip area, then the operator's fingers are clamped in the notch, preventing slippage.

In a preferred embodiment of the invention, several gripping zones can be provided on the at least one support element. This increases the probability of catching the filter unit in one of the

ES 2 290 451 T3 gripping zones in the event of accidental gripping. In addition, various grip areas allow the filter unit to be grasped on both sides, for example with two hands, thus facilitating the exchange of the filter unit.

The fact that the sterile filter between two support elements is held tightly is advantageous. In this way you are at least partially protected on both sides against contact with your fingers.

It is favorable when the sterile filter is connected, in particular glued or welded, inseparably with the at least one support element. This prevents the sterile filter from falling out. Furthermore, the exchange of the sterile filter is facilitated since it is exchanged as a unit with the at least one support element. Furthermore, the sterile filter is stabilized via the at least one support element, which is advantageous especially in the case of commonly used flexible sterile filters.

In order to protect the sterile filter even more reliably and to further increase stability, the two support elements can be inseparably connected, especially glued or welded to one another.

A particularly large passage surface for gas exchange results when the internal and / or external clamping frames are configured in the form of a ring.

The manufacture of a filter unit is especially simple and inexpensive when the connecting elements comprise radial webs oriented away from a center of the internal and external clamping frames.

The sterile filter is held even more securely if the connecting elements of the two supporting elements joined together are arranged in an overlapping manner in a direction perpendicular to a plane defined by the sterile filter. As a result, when the sterile filter is fastened on both sides between the two supporting elements in the region of the connecting elements, a particularly stable fastening of the sterile filter is achieved. Furthermore, the passage surface of the sterile filter is maximized for a gas exchange.

It is favorable when the connecting elements of the two supporting elements connected to each other, arranged rotated relative to each other, are displaced relative to each other by an angle of rotation resulting from the quotient between 360 ° and twice the number of connecting elements. For this reason, all the connecting elements in total of the filter unit serve as stabilization for the sterile filter, whereas in the case of an overlapping arrangement of the connecting elements only the simple number of connecting elements contributes to the stabilization. filter unit.

In order for the sterile filter to be held particularly securely, it is advantageous when the at least one gripping area is arranged on the external and / or internal holding frame.

To avoid inadvertent sliding of the fingers on the sterile filter, it can be advantageous when the external and / or internal clamping frame have a frame width in the radial direction, and when the at least one grip area has a width of area of grip in the radial direction, which is greater in sections at least than the frame width of the outer and / or inner clamp frame sections adjacent to the grip zone. The grip area widened accordingly with respect to the adjacent sections of the holding frames enables the filter unit to be held securely, thereby reducing the danger of fouling or damaging the sterile filter.

To further hinder a sliding of the fingers from the grip area, the at least one grip area may comprise a finger retention element. The finger retention element retains fingers that could slide from the grip area. Therefore, the finger retainer therefore arbitrarily forms a barrier for a finger.

Preferably, the finger retention element comprises an edge surrounding the gripping surface of the gripping area. The edge surrounding the gripping surface at least in sections prevents a finger when grasping the gripping surface of the gripping area from slipping off the gripping surface.

A particularly good grip can provide a structured and / or rough grip surface.

The aim set out at the beginning is achieved according to the invention with a sterile container of the type described at the beginning in that the filter unit comprises one of the filter units according to the invention described above.

By providing the sterile container with such a filter unit, the danger of fouling or damaging the filter unit is reduced, so that the functionality of the sterile container is overall improved. The risk of germs or pathogens entering the sterile container after sterilization is reduced.

The following description of preferred embodiments of the invention serves in conjunction with the drawing for a more detailed explanation. They show:

Figure 1, a perspective view of a sterile container;

2 290 451 T3 FIG. 2, a sectional cross-sectional view through a lid of the sterile container shown in FIG. 1 along line 2-2;

Figure 3 is a perspective view of a first embodiment of a filter unit; and Figure 4, a perspective view of an embodiment of a filter unit that is not part of the present invention.

In figure 1 a sterile container is represented, provided as a whole with the reference number 10, with a tray 12 to house, for example, instruments or surgical material and with a lid 14 that closes the tray 12.

The lid 14 can be connected to the bowl 12 via two closures 16 arranged on the front side in each case. Each closure comprises a support 18 arranged on the front side on the cover 14 and a bracket 20 rotatably housed therein which, in a locked state, as shown in Figure 1, embraces a locking projection 22 arranged on cuvette 12.

To allow gas exchange between an environment and the interior of the sterile container 10, two substantially circular ventilation openings 24 are symmetrically arranged in the lid which are covered by two interlocking webs 26.

On an outer side of the cover 14 each of the two ventilation openings 24 is completely covered by a protective cover 28.

In the sectional view in Figure 2 a filter cassette 30 is shown which completely covers the ventilation opening 24 inside the cover 14 comprising a semi-monocoque filter housing 32 with a filter unit 34 housed in the herself. The filter housing 32 comprises an annular filter housing frame 33 elastically pre-stressed in the direction towards the cover 14 to house the filter unit 34. The filter housing frame 33 is covered with a base 40 on a side opposite to a lower lid side 36, so that through the two pieces a flat, cylindrical filter housing 46 open in the direction towards the bottom side 36 of cover. The filter cassette 30 is configured substantially symmetrically with respect to an axis of symmetry oriented perpendicular to the lid 14. The base 40 is provided with longitudinal grooves 42 which form passage openings inclined obliquely with respect to the base 40 and with a central perforation 44.

The filter unit 34 comprises two clamping washers, namely an upper clamping washer 48 directed to the lower side 36 of the cover and a lower clamping washer 49 between which a flat sterile filter in the shape of a disk is fastened, for example a filter PTFE that can be used as a permanent filter.

As can be seen in Figures 2 and 3, each of the two clamping washers 48 and 49 comprises an external clamping ring 52 or 53 and an internal clamping ring 54 or 55 that are joined together through eight spokes 56 or 57 running radially in each case. Additionally, for stabilization purposes, inside the internal clamping ring 55 of the lower clamping washer 49 is placed an arrangement 58 of webs of two intersecting webs that supports in the center a cylindrical centering journal 60 indicating in the opposite direction to the bottom side 36 of the lid.

In order to join the lower clamping washer 49 with the upper clamping washer 48, the upper clamping washer 48 is provided with an annular groove 62 in which an annular projection 64 is engaged, pointing in the direction of the lower side 36 of the cover. In a further annular washer of the upper clamping washer, open towards the lower side 36 of the lid, is inserted a sealing ring 68 with which the upper clamping washer 48 and thus the entire filter cassette 30 can be sealed with respect to the bottom side 36 of cover.

To connect the filter unit 34 to the filter housing 32, a bayonet connection is provided between the filter housing frame 33 and the upper clamping washer. To this end, the upper clamping washer 48 supports a number of bayonet grooves 70 open on its perimeter radially outwards into which a corresponding projection, oriented radially inwards, can penetrate into the filter housing frame 33.

Furthermore, two gripping zones 72 facing each other diametrically are configured in the filter unit 34, and specifically in the outer clamping ring 53 of the lower clamping washer 49. Each gripping zone 72, symmetrically adjacent to a radius 57, is configured symmetrically thereto, an extension 74 of radius 57 separating two recesses 76 and 77 from one another, which at their base support in each case a gripping surface 78 or 79 and an edge 80 or 81 protruding from the corresponding gripping surface 78 or 79 in the form of a protrusion. Each of the two gripping surfaces 78 or 79 is further provided with a rib structure 82. Instead of rib structure 82, gripping surface 78 or 79 may be structured or roughened in any other way.

The recesses 76 and 77 have a width at their end facing in the opposite direction of the extension 74 which is slightly less than the width of the external clamping ring 53 in the radial direction. In the direction towards the extension 74 the gripping surface 78 or 79 widens on one side in the direction towards the axis 38 of symmetry. This is limited by the edge 80 at least on its side that points towards the direction of the axis of symmetry 38, however it can also

ES 2 290 451 T3 be totally surrounded by edge 80. Edge 80 serves especially as a finger retention element to prevent fingers entering recesses 76 or 77 from sliding into sterile filter 50.

The filter cassette 30 is assembled by grasping the filter unit 34 in the grip areas 72 with the fingers and inserting it into the filter housing frame 33 already mounted on the cover 14 in the direction of the axis of symmetry 38 and then rotating it around it. By the bayonet attachment, the filter unit 34 is held in the filter housing frame 33. Finally, the base 40 is displaced with its perforation 44 over the centering pin 60 and is joined with additional locking projections in the area of ​​mutually adjacent surfaces between the base 40 and the filter housing frame 33.

In the exemplary embodiment shown in FIG. 3 of a filter unit 34, the two clamping washers 48 and 49 are joined together in such a way that the spokes 56 and 57 run relative to each other offset by an angle 84 of rotation of 22 , 5 °. The sterile filter 50 is therefore not fixed between two spokes 56 and 57 but is positioned by changing sides in each case on one of the two spokes 56 or 57. By this relative orientation of the spokes 56 and 57 with respect to each other, the sterile filter is additionally protected against damage, because at the 22.5 ° separation one of the spokes 56 or 57 in each case prevents the sterile filter from being penetrated, in the event that a person or object grabs or reaches into the filter unit 34.

Figure 4 shows an example of embodiment of a filter provided as a whole with the reference number 134, which is not part of the present invention, in which the identical parts are provided with the same reference numbers and additionally with the number 1 in front. Units 34 and 134 differ in that, in filter unit 134, spokes 156 and 157 are arranged overlapping each other, such that a spacing of spokes 156 and 157 corresponds to a radius angle 186 of 45 °. The sterile filter 150 is therefore further fixed between two spokes 156 and 157, however, in this case, the free surface between adjacent spokes 156 is twice as large as in the filter unit 34.