Sterilizing container

p0001The invention relates to a sterile container, in particular for the holding and sterile storage of surgical instruments or material, comprising an accommodating space formed by a container bottom and container walls, a lid for closing the receiving space and a gas exchange opening which is closable by a held in a filter holder sterile filter, wherein the sterile filter and the filter holder form a filter unit, and wherein the filter holder is mounted on the cover, wherein the sterile filter is held on a carrier element, said carrier member having a first and a second support member, and wherein the sterile filter is held between the two support elements.

p0002Such sterile containers are sterilized with, for example, stored therein surgical instruments or material in a sterilizer. They can then be placed in a sterile operating area and opened there. The sterile filter is required in order to prevent after the sterilization process the penetration of germs into the receiving space of the container. However, this filter must be replaced from time to time. This is only possible with known cumbersome sterile containers. Moreover, the production of a cover with integrally arranged thereon filter holder is very expensive.

p0003Examples of the sterile container, in particular for the holding and sterile storage of surgical instruments or material, are known from <patcit id="pcit0001" dnum="US5176884A"><text>US 5,176,884</text></patcit>, of the <patcit id="pcit0002" dnum="DE3407112A1"><text>DE 3407112 A1</text></patcit>, of the <patcit id="pcit0003" dnum="US5324489A"><text>US 5,324,489</text></patcit> and the <patcit id="pcit0004" dnum="US5183643A"><text>US 5,183,643</text></patcit> known.

p0004Therefore, it is object of the present invention to improve a sterile container of the type described above so that a stability of the filter unit is increased.

p0005This object is in a sterile container of the kind described at the outset, that the support element comprises a first and a second supporting element (42,43) and wherein the sterile filter (52) between the two support elements (42,43) is held, at least one of the two supporting elements, the gas exchange opening comprises at least partially cross-support sections for supporting the sterile filter.

p0006This configuration makes it possible to optionally replace completely the filter unit. Given the sterile filter must especially when loading no longer even resorted, on the one hand to avoid damage thereto, on the other hand soiling is prevented. The manufacture of the cover is simplified, as the filter holder can be mounted on the lid later. To avoid damage to the sterile filter, the sterile filter is held on a carrier element. To increase the stability and maintain the form of the sterile filter, the support element comprises a first and a second support member held and the sterile filter between the two support elements. The sterile filter can thereby be sure to take the support member without the filter is dirty or damaged. To further increase the stability of the filter unit is provided, that at least one of the two support elements comprises the gas exchange opening at least partially cross-support sections for supporting the sterile filter. Thereby, although the gas exchange opening is reduced, free surfaces of the sterile filter, but also, so that it is possible to stabilize the shape thereof, which is advantageous in particular when acted upon by pressurized superheated steam.

p0007It is advantageous if the sterile filter and the filter holder are detachably connectable when the sterile filter in a removal position of the filter holder is detachable and held in a connecting position on the filter holder. In this way, only the sterile filter itself needs to be replaced, not the entire filter unit during filter replacement. Although the filter unit could be replaced altogether, however, would then at a still intact filter holder it replaces, although this would not be necessary. Consequently, the whole of the sterile container is improved.

p0008According to a preferred embodiment of the invention it can be provided that the sterile filter, the first and second supporting elements are inextricably linked, in particular glued, clamped or welded. Thus, a total of dimensionally stable unit comprising formed the support element and the sterile filter, whereby the exchange is facilitated thereof.

p0009The support element and the filter holder can be interconnected in various ways, for example, screwed or jammed. It is particularly advantageous if a bayonet connection is provided for connecting the support element and the filter holder and for transferring the carrier element from the removal position into the connection position. The support element can be easily connected to the sterile filter, namely by the carrier element is first inserted into the filter holder and then rotated through a certain angle range, which depends substantially on the number of mutually engageable bayonet projections and recordings and their angular extent. The connecting position is usually defined by relative strokes between the support element and the filter holder, which limit a rotational movement.

p0010In order to ensure a defined connected position and prevent release of the sterile filter from the filter holder, it is advantageous when a locking mechanism is provided for locking the connection position of the sterile filter and the filter holder.

p0011Particularly easily implement a locking mechanism by a locking connection.

p0012In a further advantageous embodiment of the invention it can be provided that the filter unit comprises a cover for covering one side of the sterile filter. Thus, the sterile filter on one side protected against damage, for example by the stored in the sterile container objects.

p0013To ensure an optimal gas exchange and at the same time safely protect the sterile filter from damage, it may be advantageous if the cover is provided with openings for allowing gas exchange through the apertures therethrough and when the perforations in a direction transverse to a forward direction with opening covers are covered.

p0014Preferably, the cover is spaced apart from the sterile filter. This prevents that the sterile filter does not come when subjected to superheated steam in contact with the cover, if the sterile filter deformed, for example, bulges.

p0015The cover and the filter holder may be Although formed in one piece, in a preferred embodiment of the invention but it can be provided that the cover with the filter holder can be releasably connected, in that the cover in a decreasing position of the filter holder is removable and held in a closure position on the filter holder is , The cover can thus be removed easily in order to exchange the sterile filter.

p0016The cover could be fixed, for example with screws or clamps on the filter holder, but it is particularly advantageous if a second bayonet connection is provided for connecting the cover and filter holder and for transferring the cover from the decreasing position into the closure position. A compound could be prepared for example by the cover is inserted with corresponding projections in recesses of the filter holder and then twisted as a whole relative to the filter holder. Conversely, can the cover removed easily.

p0017To avoid unintentional release of the cover from the filter holder a second locking mechanism is provided for locking the cover and the filter holder in the closure position.

p0018The second locking mechanism could be implemented, for example by means of a separately actuated locking element. It is particularly simple, however, when the second locking mechanism comprises a second latching connection. Here all kinds of snap connections are possible, for example, spring-loaded locking projections, which engage in corresponding recesses.

p0019Further, it is advantageous if the support member comprises a be brought into engagement with the cover centering element for centering of the cover on the filter holder. Thus, the placement of the cover is particularly facilitated and simplified. In addition, the centering aid can also serve as a stop to help prevent damage to the sterile filter through the cover.

p0020In addition, to control a gas exchange between the receiving space and the environment of the sterile container and / or closed, it can be advantageous if the filter unit is mounted for movement, when the filter unit in a closed position closes a flow path and in an open position to open the flow path, so that gas exchange in the closed position is possible only through the sterile filter and in the open position through the sterile filter and / or through the flow path. Thus, particularly when a larger gas exchange is necessary, transferred to the filter unit in the open position and an additional flow path to be opened.

p0021Is particularly simple assembly of the sterile container when storage elements are provided for supporting the filter unit on the cover on the filter holder and the lid.

p0022A particularly simple design of the sterile container with a movably mounted filter unit results in an advantageous manner if the storage elements comprise at least one bearing pin and an assigned bearing bush when the bearing pin at each end has a stop for limiting movement of the bushing relative to the bearing pin and when the bearing bolt on the cover and the bearing bush on the filter holder or positioned inversely.

p0023No additional parts are required when one of the two stops is formed by the cover and the other stop by a head of the bearing bolt.

p0024Enhanced protection of the storage elements is obtained when the cover covers the storage elements. In this way, the storage elements are protected against accidental manipulation.

p0025To close an additional flow path, thereby allowing an aseptic storage in sterile containers of stored objects, the filter unit in the closed position on the sterile container is maintained under pretension.

p0026Such bias can be realized when supported acting in the longitudinal direction of the bearing pin biasing element between one of the two stops and the bearing bush particularly easy. As a biasing element can be any elastic elements, for example, coil springs or rubber elastic elements, can be used.

p0027It is advantageous if a sealing element for gas-tight storage of the filter unit is provided on the lid. Characterized a complete seal of the filter unit can be realized on the cover, so that a gas exchange is possible only through the sterile filter through.

p0028it if the sealing element comprises a bearing on the carrier element sealing ring is particularly favorable. Sealing rings are particularly easy to manufacture and arrange in a simple manner on the carrier element.

p0029According to a further preferred embodiment of the invention, it is advantageous if a pressure relief valve is provided, when the pressure relief valve is arranged so that it occupies a closed position to an initial position and when it adopts a passage position when a pressure in an environment of the sterile container a pressure exceeds in the sterile container by a predetermined pressure difference. In this way, damage to the sterile container can be avoided, because before the sterile container may be deformed in the area or a correspondingly high pressure gradient due to a particularly large pressure opens the relief valve and allow the inflow of gas into the container.

p0030No additional components and other openings are required if the filter unit forms the overpressure valve. The filter unit thus performs two functions, on the one hand it serves the retention of germs, the other as a pressure relief valve.

p0031Preferably, a filter unit is spaced above opaque protective member is provided. This is particularly the sterile filter from mechanical damage can safely protect.

p0032it, when the filter unit is mounted on an inner side of the cover and when the protective element is disposed on an outer side of the cover is particularly favorable. Thus, the filter unit with the sterile filter from both sides is safely protected from mechanical stresses.

p0033To minimize impingement of the sterile filter with liquid, it is advantageous, if between the protective element and the lid associated with, the gas exchange opening in fluid connection gas passage opening is provided at least, arranged so that a gas flow in a substantially transverse to the forward direction of the sterile filter extending flow direction is made possible. In this way, gas, such as superheated steam for sterilization, pass through easily through the sterile filter, while liquids are first kept away from the sterile filter.

p0034To make it harder for liquids in addition to penetrate into the filter unit, it is advantageous if one arranged on the outside of the lid and of the gas exchange opening facing away, is provided outwardly relative sloping to a lid plane inflow. If a liquid on the cover, it may flow from the gas exchange opening away and therefore not reach the filter unit due to the inclination of the inflow.

p0035To facilitate installation of the filter holder and increase the stability of the same, is provided in a preferred embodiment of the invention that the filter holder against rotation is mounted on the cover.

p0036Preferably, the sterile filter is a durable filter, in particular made from polytetrafluoroethylene (PTFE). This maintenance intervals of the sterile container can be extended, for a total replacement of the filter unit only rarely required.

p0037Particularly cheap and simple to manufacture the sterile container, when the lid is made of a plastic, in particular polyetheretherketone (PEEK) or polyphenylene (PPSU).

p0038The following description of a preferred embodiment of the invention serves in conjunction with the drawings for further explanation. Show it:<dl id="dl0001"><dt>Figure 1:</dt><dd>An exploded view of a disassembled, three-part filter unit;</dd><dt>Figure 2:</dt><dd>a sectional view taken along line 2-2 in <figref idrefs="f0001">figure 1</figref> and</dd><dt>Figure 3:</dt><dd>a sectional view taken along line 3-3 in <figref idrefs="f0001">figure 1</figref>,</dd></dl>

p0039In the <figref idrefs="f0001 f0002 f0003">Figures 1 to 3</figref> there is shown a whole with the reference numeral 10 provided, three-piece filter unit which is mounted on a cover 12 of a sterile container, not shown.

p0040The filter unit 10 comprises a cover 12 connected with the holding frame 14, an insertable in the holding frame 14 and can be connected to this filter element 16, and a connectable to the support frame 14 cover the eighteenth

p0041The holding frame 14 includes an octagonal outer contour having cover plate 20 which has a circular opening 22 which is surrounded by a circumferential inner edge 24th A peripheral outer edge 26 adjoins the octagonal outer contour of the cover plate 20 so that is formed in the cross section is substantially U-shaped hollow profile. circumferentially offset by 90 ° in the cover plate four identical, used as bushings 28 serving cylindrical sleeves, which have at their 20 away from the cover plate end a parallel to the cover plate 20 extending, inwardly facing annular flange 30th Between the bushes 28 are four identical, to positioned over an angular range of 45 ° extending slots 32, which are partly covered by an integrally formed with the cover plate 20 projection 34, to which a circumferentially oriented, molded resilient locking lug joins 36, which is somewhat movable perpendicular to the cover plate 20 and on a 20 pointing away from the cover plate side has a non-illustrated small spherical projection. The projection 34 and the locking lug 36 cover approximately 40% of the slot 32 in the circumferential direction from one end of the slot 32 starting.

p0042Further, the inner edge 24 with four symmetrically distributed over the circumference, extending circumferentially and radially inwardly projecting radial protrusions 38 which extend approximately over an angular range of 40 °. On one side, the radial projections 38 are extended with offset parallel projecting locking tabs 40 which are perpendicular to the top plate 20 a little movable.

p0043A free, from the cover plate 20 facing away edge line 27 of the outer edge 26 is partially curved and designed to correspond to a non-illustrated internal surface of the lid 12, which can be realized on the cover 12 is a positive contact of the holding frame fourteenth

p0044The filter element 16 comprises two clamping plates 42 and 43, the 46 and 50 each comprise a eight radially extending webs to an outer ring 44 and inner ring 48 connected to 45 and 49th The inner ring 45 of the clamping plate 42 is located four cross-shaped retaining elements 54 passes through the central wear a centering 56th Between the clamping plates 42 and 43, a sterile filter 52 is inserted, which completely covers the 44 and 48 delimited by the outer rings annular opening 58th The two clamping plates 42 and 43 and the sterile filter 52 are fixed to each other, for example, glued or ultrasonically welded, and form a single unit.

p0045The outer diameter of the annular filter element 16 corresponds to the inner diameter of the opening 22 of the holding frame 14 and can therefore be inserted into this opening 22nd For connecting the filter element 16 with the holding frame 14 of the outer ring 48 is provided with four symmetrically distributed over the circumference receiving grooves 60 which are opened radially outward. Each lateral end of the groove 60 is closed with a Nutendwand 62nd The filter element 16 is inserted into the holding frame 14 so that the four grooves 60 engage between the radial projections 38 provided with the portions of the inner edge 24th A radially projecting Außenringflansch 64 of the outer ring 48 is located in such a position in the radial protrusions 38th The filter element 16 is now rotated so far, until the Nutendwand 62 abuts against the end edge 39 of which engages in the receiving groove 60 radial projection 38th In this connection position of the holding frame 14 and the filter element 16 which is arranged on the latching tongue 40 projections in corresponding recesses 66 at the open end immerse a respective side wall 61 of the receiving groove, which results in a latching locking the connection position.

p0046Furthermore, the outer ring 48 is provided with an open facing away from the outer ring 44 annular groove 68, into which a sealing ring 70 is inserted.

p0047The filter unit 10 is closed by the cover 18, which has an outer contour of the cover plate 20 corresponding octagonal base plate 72, which is provided with a central bore 74 for introducing the centering 56th A circular area 76 is provided with in quarter circle sectors each parallel slots 78 of different lengths, so that webs 80 remaining between the slots 78, which project obliquely, approximately at an angle of 60 ° extended relative to the baseplate 72 to extend. Slanted web regions 81 cover the slots 78 respectively completely so that obliquely extending channels are formed 82nd A direct passage perpendicular to the base plate 72 through the slots 78 is not possible.

p0048From a bottom 84 of the base plate 72 protrude four symmetrically distributed, off over an angle of about 30 ° extending, cross-sectionally L-shaped retaining projections 86, having their one free leg at one end a perpendicular to the base plate 72 extending bore 88th

p0049The cover 18 is connected to the holding frame 14 as follows: the cover 18 is introduced with the retaining projections 86 in not of projections 34 covered areas of the slots 32, until the underside 84 of the base plate 72 abuts against the cover plate twentieth By rotating the cover 18 clockwise engage behind the free leg of the retaining projections 86, the projections 34, to an end face 87 of the retaining projection 86 abuts a front edge 33 of the slot 32nd In this closed position a dive arranged on the latching lug 36 hemisphere 37 into the hole 88 and locks the closed position of the cover 18 and the holding frame fourteenth

p0050In connection with <figref idrefs="f0002">figure 2</figref> the attachment of the holding frame 14 is illustrated on the cover 12th On the cover 12 are arranged vertically from the lid 12 away spreading adjacent to a non-illustrated circular opening on its inside four substantially cylindrical retaining bolts 90th The holding frame 14 is slid with the bushings 28 via the retaining bolt 90, so that the annular flange 30 surrounding the rest retaining bolt 90 at the inside of the lid 12th Each retaining pin 90 is surrounded by a helical spring 92 which is supported on one side on the annular flange 30 on the other side to an annular flange 94 of a lid 96 which has a central bore 97 whose internal diameter corresponds to the outer diameter of the retaining bolt 90th The lid 96 is ultrasonically welded or glued to the retaining bolt.

p0051Because of this storage, it is possible to lift the entire filter unit 10 from the inside of the lid 12 against the bias of the coil springs 92nd This happens for example when a container with a sterile filter unit 10 disposed thereon is introduced into a sterilizer and is subjected to hot steam under pressure. The sterile container surrounding the pressure is higher than the pressure inside the container, in this case, so that the entire filter unit 10 lifts off the lid 12 and an additional flow path open for the inflow of hot steam. This prevents that the sterile container is deformed due to excessive applied pressure differences. Is the pressure acting from the outside back again, the filter unit 10 is biased by the coil springs 92 against the inside of the lid 12th The sealing ring 70 is in this closed position to seal against a corresponding projection 98 of the lid 12, so that only a gas exchange through the sterile filter 52 through the interior of the sterile container is in possible. Due to this resilient mounting the entire filter unit 10 also takes over the function of a relief valve.