DE102004020805B3 - Sterile container for surgical instruments and material has lid with gas exchange aperture which is closed by filter which also acts as pressure release valve - Google Patents

Abstract

Sterile container for surgical instruments and material has a lid (10) with a gas exchange aperture (24). This is closed by a filter (26) which also acts as a pressure release valve.

Description

The The invention relates to a sterile container, in particular for receiving and sterile storage of surgical utensils or surgical material, with one through a container bottom and container walls formed Reception room, with a lid to close the recording room, with a gas exchange opening, which of a held in a filter holder sterile filter lockable is and with at least one pressure relief valve, which is a valve opening and a flapper for opening and closing having the valve opening, the pressure relief valve is designed such that it assumes a closed position in a basic position, in which the valve opening is closed, and that it is at a minimum pressure difference between in the receiving space and in an environment of the sterile container prevailing pressures one Durchlasstellung occupies, in which the valve opening at least partially open is, wherein the sterile filter forms the valve flap.

Sterile container of The type described above are known in numerous variants. The sterile filter allows a fluid exchange, that is an exchange of gases, liquids or gas-liquid mixtures, in particular air, between an environment and the receiving space of the sterile container, prevents at the same time that germs and bacteria in the Can reach the recording room. As a gas flow through the sterile filter basically limited is, it can happen, in particular when sterilizing the sterile container, that large pressure gradients arise between an environment of the sterile container and the receiving space can. To both an implosion and an explosion of the sterile container too It is known to be closed under normal conditions Provide secondary current paths that exceed a certain Open pressure differential between the receiving space and the environment of the sterile container, at least briefly increased air mass exchange enable and so damage of the sterile container avoid helping. Nebenstrompfade can, for example in the form of additional on the sterile container provided openings be formed, which e.g. selectively closed by means of pressure relief valves can be. Indeed means the provision of a pressure relief valve An additional Effort in the production, combined with an additional Maintenance and cleaning, as the function of the pressure relief valve checked regularly and that Valve must be cleaned about damage of the sterile container and the undesirable Prevent germs from entering through the valve.

From the generic DE 102 10 905 A1 a sterile container is known in which a movably mounted on the sterile container filter unit forms a pressure relief valve. A similar sterilization container is in the DE 34 38 463 A1 disclosed. Another such sterile container is from the DE 101 56 937 A1 known. Further sterile containers with filters are described in WO 99/27969 A2, in WO 96/07436 A1, in DE 35 00 026 A1 , in the DE 29720 450 U1 , in the DE 41 111 077 A1 , in the DE 34 07 112 A1 , in the US 4,661,326 and in US 2003/0072701 A1.

It is therefore an object of the present invention, a sterile container of initially described type to improve so that it is easy to manufacture and to wait is.

These Task is in a sterile container of The type described above, according to the invention achieved in that the gas exchange opening comprises the valve opening and that a part the valve flap is immovably held on the sterile container.

These Design makes it possible with the sterile filter on the one hand to prevent germs and Bacteria in the sterile container can reach, and on the other hand, excessively high Pressure gradients catch, through which the sterile container damaged or completely complete destroyed can be. In that at least a part of the valve flap and thus a part of the sterile filter immovable on the sterile container held, a remaining part of the valve flap can be closed high pressure gradient the valve opening, according to the vorlie ing Invention a part of the gas exchange opening, release. The gas exchange opening is used So at the same time as a valve opening, so that no further openings on the sterile container must be provided. Furthermore, the sterile filter can not slip, as it at least partially immovably held on the sterile container.

Advantageous it is when the sterile filter is placed on an inside of the sterile container is. In the sterile container It is particularly good against damage, especially during transport of the sterile container protected. additionally For example, a protective device in the form of a gas exchange opening of covering outside Be provided protective cover.

In order to the functionality the valve flap in the desired Way, it is convenient if the sterile filter is flexible and / or flexible.

To make a one hundred percent waterproofing of To ensure sterile container in the closed position, it is advantageous if the valve flap carries a seal that rests in the closed position surrounding the valve opening on the sterile container. In this way, a gas exchange between the receiving space and an environment of the sterile container in the closed position can only take place through the sterile filter, which forms a sterile barrier for germs and bacteria.

One Replacement of the sterile filter, for example due to contamination or damage, can be done easily if the sterile filter and the filter holder solvable are connectable when the sterile filter in a removal position detachable from the filter holder and held in a connection position on the filter holder is.

advantageously, comprises the sterile filter a holding frame and held on the holding frame Filter media. The support frame allows the sterile filter to without touching the filter medium itself come. As a result, the filter medium is protected, in particular against contamination or damage.

Around to adjust the operation of the valve flap in the desired manner can, is it cheap when the support frame is flexible and / or flexible. This can be done the overall designed as a resilient element valve flap in designed in a way that with Pressure differences below the minimum pressure difference the valve flap the closed position occupies, at higher pressure differences as the minimum pressure difference, the passage position.

Of the Construction of the sterile filter becomes particularly easy when the support frame the seal is wearing. Further This facilitates the maintenance of the sterile container, as with a Replacement of the support frame and at the same time the gasket to be replaced can.

One particularly stable construction of the sterile filter is achieved by the holding frame comprises a first and a second frame part and by the filter medium is held between the two frame parts. In this way, the filter medium is additionally protected.

In order to not even at low pressure differences between the receiving space and an environment of the sterile container the filter medium in unwanted Way arched and possibly damaged can be, conveniently be provided that at least one of the two frame parts, the gas exchange opening at least partially overlapping Support sections for supporting of the filter medium. This can additionally a thickness of the filter medium can be reduced, whereby a gas exchange between the receiving space and the environment of the sterile container is facilitated.

Conceivable would it be, form the holding frame in two parts in such a way that a between the two frame parts einbringbares filter medium are exchanged can. Since when replacing the filter medium this damaged or It can be polluted, it is for the handling of the sterile container very cheap, if the filter medium, the first and the second frame part insoluble with each other are connected, in particular glued, jammed or welded, and form a filter unit. This allows the filter unit replace as a whole, so in particular the entire valve flap, if their function can no longer be guaranteed.

Around Maintenance intervals of the sterile container too extend, It may be advantageous if the filter medium is a permanent filter is, in particular made of polytetrafluoroethylene (PTFE).

Basically, the pressure relief valve as outlet valve be educated. conveniently, is the pressure relief valve but in the form of an inlet valve formed, which assumes the passage position, if a in the environment of the sterile container prevailing pressure a pressure prevailing in the receiving space around the Exceeds minimum pressure difference. This is especially the common occurring situation that during a sterilization process in the environment of the sterile container a much higher one Pressure prevails as in the recording room. The inflow of superheated steam into the receiving space is achieved by opening the pressure relief valve facilitated.

In order to even with pressure differences between the recording room and the environment of the sterile container, which are smaller than the minimum pressure difference, the pressure relief valve remains in the closed position and also without a prevailing pressure difference, the valve opening safely can be closed, it is advantageous if the valve flap in the closed position held under pretension on the sterile container is. In particular, over the bias also the desired Minimum pressure difference can be specified at which the valve flap the valve opening releases.

Of the Structure of the sterile container becomes particularly easy if the sterile filter and the gas exchange opening are circular or essentially circular are formed.

According to a preferred embodiment of the invention can be provided that the sterile Filter having at least one holding portion, that the filter holder comprises at least one holding element and that the at least one holding element holds the at least one holding portion immovably on the sterile container. In this way it is ensured that at least a part of the sterile filter is immovably held on the sterile container. As a result of a pressure difference which is higher than the minimum pressure difference, the sterile filter can deform, whereby the valve opening is opened and a gas flow can flow through the valve opening to reduce the prevailing pressure difference.

Around a secure hold of the sterile filter to the sterile container guarantee, it is advantageous if at least two retaining elements are provided.

One Particularly simple construction of the at least one retaining element is achieved by the at least one retaining element covering the holding portion Holding arm which parallel or substantially parallel to a gas exchange opening surrounding wall of sterile container is arranged running. In this way, for example, a Part of the sterile filter in a press fit between a wall of the Sterile container and the holding arm to be held immobile.

Around a damage of the filter medium, it may be advantageous if the Holding arm a holding frame portion of the holding frame at least partially covered. The sterile filter is not in this way on the filter medium, but on the Holding frame held.

Advantageous It is when the at least one retaining element over a Angular range extends in the circumferential direction of the sterile filter. In order to will ensure that the Sterile filter on the one hand at least partially immovable held on the sterile container is, on the other hand, enough Travel for one Deformation of the sterile filter for ingestion of the passage position remains.

Especially It is advantageous if the angular range has values of 10 ° to 180 °. Especially with an angular range of about 180 ° it can be sufficient to provide a single holding element, with which the Sterile filter then about half immovable on the sterile container can be held.

One especially small and compact construction of the holder becomes possible if more than one holding element is provided and if the angle range a Value from 10 ° to 30 °, in particular 20 °.

Around the sterile filter in a defined and possibly centered position the gas exchange opening keeping it low, it is convenient if at least two holding elements are provided and if the at least two retaining elements symmetrically around the gas exchange opening around are arranged.

According to one preferred embodiment of Invention may be provided that a holding element provided is and that the Angular range a value of 180 ° or in about 180 °. This allows the sterile filter, for example, parallel to a wall surface of the sterile container to insert into a receptacle defined by the one holding element.

In order to the sterile filter completely covers the gas exchange opening at all times, it is favorable to provide centering stops for centering the sterile filter over the gas exchange opening.

In principle, it would be conceivable the gas exchange opening on a container wall or at the bottom of the container provided. Preferably, however, the gas exchange opening is provided on the lid. That's how it works for example, even with a filled sterile container the Easily replace the filter by removing the lid, the sterile filter is removed and a new one is inserted.

Around a damage of the sterile filter, it is beneficial if at least a stop is provided, which is an opening movement of the valve flap from the valve opening limited way. By the stop so also a maximum opening of Valve flap in the open position specified. Furthermore at the same time becomes excessive deformation the valve flap due to an increased pressure difference between the receiving space and the environment of the sterile container prevented.

Especially Simple to manufacture and especially easy is the sterile container, though the lid is made of a plastic material, in particular Polyetheretherkethon (PEEK) or Polyphenylensulfon (PPSU). Further let yourself a lid made of a plastic almost in any way colorize. It would be possible it also to reinforce the plastic, for example by carbon fibers and / or glass fibers.

The following description of preferred embodiments of the invention used in conjunction with the drawings for further explanation. Show it:

1 : a top view on an inside egg nes first embodiment of a container lid;

2 a sectional view taken along line 2-2 in FIG 1 ;

3 a sectional view taken along line 3-3 in FIG 1 ;

4 a plan view of an inside of a second embodiment of a container lid;

5 a sectional view taken along line 5-5 in 4 ;

6 a sectional view taken along line 6-6 in 4 ;

7 a plan view of an inside of a third embodiment of a container lid; and

8th a sectional view taken along line 8-8 in FIG 7 ,

In 1 is a total with the reference numeral 10 provided lid for a container trough, not shown, of the lid 10 and the container tub comprehensive sterile container shown. The lid is substantially square and has rounded corners 12 on. From a substantially flat lid surface 16 there is a lid edge 14 from which side walls of the container trough of the sterile container partially covered. To connect the lid 10 with the container trough are two locking flaps 18 symmetrical on mutually parallel sections of the lid edge 14 arranged.

To exchange gas between an environment 20 and an interior 22 of the sterile container 10 , which serves as a receiving space, for example, for surgical instruments and surgical material to allow, is the lid 10 in the middle with a circular opening 24 Mistake. This will be on an inside of the lid 10 from a likewise circular filter unit 26 completely covered. To the stability of the lid 10 increase are the opening 24 overarching and subdividing into individual segments webs 28 integral with the lid surface 16 connected.

The filter unit 26 is formed by two frame halves 30 and 32 between which is held a polytetrafluoroethylene (PTFE) continuous filter formed in the form of a flat filter disk. The two frame halves 30 and 32 are essentially identical and comprise an outer frame ring 36 respectively 38 , which are connected directly adjacent to each other, preferably glued or welded. Concentric with the outer frame rings 36 and 38 are a center of the same surrounding inner frame rings 40 and 42 provided, which with these eight, symmetrically arranged, extending in the radial direction support webs 44 are connected. They essentially serve to stabilize the frame rings 36 and 40 respectively 38 and 42 the frame halves 30 and 32 as well as to support the permanent filter 34 , The inner frame rings 36 and 38 additionally by a support cross 46 stabilized, which two are in the center of the two frame halves 30 and 32 includes appropriate webs.

For easier handling of the filter unit 26 this has a total of four gripping surfaces 48 which is essentially parallel to the permanent filter 34 on the outer frame rings 40 and 42 arranged in pairs adjacent to each other and diametrically opposite each other and in the form of a toward the center of the frame halves 30 and 32 widened ring portion are formed.

The three in the 1 to 8th illustrated embodiments are consistent with respect to the above-described features of the lid 10 however, differ in the way in which the filter unit 26 on the lid 10 is held. Therefore, below in one in the 4 to 6 illustrated second embodiment of a lid 10a and at one in the 7 and 8th illustrated third embodiment of a lid 10b identical reference numerals used for identical elements.

The holder of the filter unit 26 gets at the lid 10 by means of two retaining clips 50 and 52 realized, which are identically formed and diametrically opposite to each other adjacent to the opening 24 are arranged. The two brackets 50 and 52 are each formed in one piece and comprise a cuboid, with the lid surface 16 connected part 54 respectively 56 and one each of this projecting, parallel to the lid surface 16 extending projection 58 respectively 60 , The headband 50 and 52 are arranged so that the projections 58 and 60 each facing each other. Overall, the headband form 50 and 52 thus two groove-like shots 62 respectively 64 for the filter unit 26 , in which these parallel to the lid surface 16 can be inserted. The projections 58 and 60 overlap sections of the outer frame rings 36 and 38 the frame halves 30 and 32 , An optimal clamping fit of the filter unit 26 in the recordings 62 and 64 the headband 50 and 52 is achieved by one in an annular groove 66 of the frame ring 36 inserted sealing ring 62 , which from the frame ring 38 towards the cover surface 16 something protrudes. The sealing ring 68 is elastic, so that manufacturing tolerances both in the brackets 50 and 52 as well as the filter unit 26 can be compensated.

The means of the headband 50 and 52 on the lid 10 held filter unit 26 acts on the one hand as a sterile barrier, on the other hand as a pressure relief valve, whose function in conjunction with the 2 and 3 will be explained in more detail below.

The filter unit 26 is in the shots 62 and 64 immovable on the lid surface 16 held. Moreover, due to a resilient embodiment of the frame halves 30 and 32 elastic and flexible serving as a valve flap filter unit 26 relative to the lid surface 16 movable. For example, exceeds one in the environment 20 of the sterile container prevailing pressure in the interior 22 prevailing pressure by a certain value, so the filter unit bulges 26 through, which causes the frame halves 30 and 32 except for her in the shots 62 and 64 held portions of the lid surface 16 lift off and a valve opening 70 release so that a gas flow from the environment 20 through the opening 24 in the interior 22 can flow in to reduce a pressure difference.

Decreases the pressure difference between the environment 20 and the interior 22 again below a certain value, then goes the filter unit 26 back to its original shape and closes the opening 24 completely, allowing a gas exchange between the environment 20 and the interior 22 only through the permanent filter 34 through is possible. The sealing ring 68 lies in this closed position again on its entire circumference on the lid surface 16 at.

As protection for the filter unit 26 is one on an outside of the lid 10 Clip on protective cover 72 provided, which the opening 24 completely covered and due to a weak curvature prevents, for example, forming condensate directly on the filter unit 26 and instead of the opening 24 is routed away.

The in the 4 to 6 illustrated lid 10a is different from the lid 10 only in that in addition to the headband 50 and 52 two similar trained attacks 74 and 76 are provided, in the same way, but relative to the brackets 50 and 52 offset in the circumferential direction in each case by 90 °, diametrically opposite each other adjacent to the opening 24 are arranged. They differ from the headband 50 and 52 in that a distance 78 between the projections 58 respectively 60 and the lid surface 16 is less than a distance 80 between protrusions 82 and 84 the attacks 74 respectively 76 and the lid surface 16 , In this way, an opening movement is due to one in the environment 20 acting overpressure arching filter unit 26 limited, by the fact that the outer frame ring 36 at the projections 82 and 84 strikes. So will a maximum valve opening 70 given what the lid 10 as he is in the 1 to 3 is not the case, because the lid 10 could be the filter unit 26 continue to bulge.

In the in the 7 and 8th illustrated lid 10b is only a single retaining projection 86 for holding the filter unit 26 on the lid surface 16 intended. The retaining projection 86 has the same cross section as the headband 50 and 52 but not just one in 1 with the reference numerals 88 respectively 90 provided angular range of about 20 °, but extends over an angular range 92 of 180 °. In this way, a semi-annular, groove-like recording 94 for the filter unit 26 formed, in which this parallel to the lid surface 16 can be inserted and held in place by clamping. Similar to the projections 58 and 60 engages over a retaining projection 96 of the holding element 86 the outer retaining ring 36 the frame half 30 but about half of the circumference of the frame ring 36 ,

The filter unit 26 is in the recording 94 immovable on the lid surface 16 However, it can fulfill the function of a valve flap, as one from the recording 94 protruding area of the filter unit 26 is free to move and as a result of being in the area 20 opposite the interior 20 acting positive pressure deformed and a valve opening 70 releases.

All elements of the lid except the locking flap 18 are made of a plastic.

Claims (32)

Sterile container, in particular for receiving and sterile storage of surgical utensils or surgical material, having a receiving space formed by a container bottom and container walls, having a lid ( 10 . 10a . 10b ) for closing the receiving space ( 22 ), with a gas exchange opening ( 24 . 70 ), which one of in a filter holder ( 50 . 52 ; 86 ) held sterile filter ( 26 ) is closable, and with at least one pressure relief valve ( 26 . 70 ), which has a valve opening ( 70 ) and a valve flap ( 26 ) for opening and closing the valve opening ( 70 ), wherein the pressure relief valve ( 26 . 70 ) is designed such that it is in a basic position a closed position occupies, in which the valve opening ( 24 . 70 ) is closed and that it is at a minimum pressure difference between in the receiving space ( 22 ) and in an environment ( 20 ) of the sterile container prevailing pressures assumes an open position, in which the valve opening ( 70 ) is at least partially opened, wherein the sterile filter ( 26 ) the valve flap ( 26 ), characterized in that the gas exchange opening ( 24 . 70 ) the valve opening ( 70 ) and that a part of the valve flap ( 26 ) is immovably held on the sterile container. Sterile container according to claim 1, characterized in that the sterile filter ( 26 ) is arranged on an inner side of the sterile container. Sterile container according to claim 1 or 2, characterized in that the sterile filter ( 26 ) is designed to be flexible. Sterile container according to one of the preceding claims, characterized in that the sterile filter ( 26 ) is flexible. Sterile container according to one of the preceding claims, characterized in that the valve flap ( 26 ) a seal ( 66 ), which in the closed position, the valve opening ( 70 ) surrounding the sterile container. Sterile container according to one of the preceding claims, characterized in that the sterile filter ( 26 ) and the filter holder ( 50 . 52 ; 86 ) are detachably connectable that the sterile filter ( 26 ) in a removal position from the filter holder ( 50 . 52 ; 86 ) releasably and in a connection position on the filter holder ( 50 . 52 ; 86 ) is held. Sterile container according to one of the preceding claims, characterized in that the sterile filter ( 26 ) a holding frame ( 30 . 32 ) and on the holding frame ( 30 . 32 ) held filter medium ( 34 ). Sterile container according to claim 7, characterized in that the holding frame ( 30 . 32 ) is designed to be flexible. Sterile container according to claim 7 or 8, characterized in that the holding frame ( 30 . 32 ) is flexible. Sterile container according to claim 7 to 9, characterized in that the holding frame ( 30 . 32 ) the seal ( 66 ) wearing. Sterile container according to one of claims 7 to 10, characterized in that the holding frame ( 30 . 32 ) a first and a second frame part ( 30 . 32 ) and that the filter medium ( 34 ) between the two frame parts ( 30 . 32 ) is held. Sterile container according to claim 11, characterized in that at least one of the two frame parts ( 30 . 32 ) the gas exchange opening ( 24 . 70 ) at least partially overlapping support sections ( 44 ) for supporting the filter medium ( 34 ). Sterile container according to one of claims 11 or 12, characterized in that the filter medium ( 34 ), the first and the second frame part ( 30 . 32 ) are inseparably connected to each other, in particular glued, clamped or welded, and a filter unit ( 26 ) form. Sterile container according to one of claims 7 to 13, characterized in that the filter medium ( 34 ) a permanent filter. A sterile container according to claim 14, characterized in that the permanent filter of polytetrafluoroethylene (PTFE) is made. Sterile container according to one of the preceding claims, characterized in that the overpressure valve ( 26 . 70 ) in the form of an inlet valve ( 26 . 70 ) is formed, which assumes the passage position, if one in the environment ( 20 ) of the sterile container, a pressure prevailing in the receiving space ( 22 ) prevailing pressure exceeds the minimum pressure difference. Sterile container according to one of the preceding claims, characterized in that the valve flap ( 26 ) is held under preload on the sterile container. Sterile container according to one of the preceding claims, characterized in that the sterile filter ( 26 ) and the gas exchange opening ( 24 . 70 ) are circular or substantially circular in shape. Sterile container according to one of the preceding claims, characterized in that the sterile filter ( 26 ) at least one holding section ( 36 . 38 ), that the filter holder ( 50 . 52 ; 86 ) at least one retaining element ( 50 . 52 ; 86 ) and that the at least one retaining element ( 50 . 52 ; 86 ) the at least one holding section ( 36 . 38 ) immovably held on the sterile container. Sterile container according to claim 19, characterized in that at least two holding elements ( 50 . 52 ) are provided. Sterile container according to one of claims 19 or 20, characterized in that the at least one holding element ( 50 . 52 ; 86 ) one the hold section overlapping support arm ( 58 . 60 ; 96 ) which is parallel or substantially parallel to a gas exchange opening ( 24 . 70 ) surrounding wall ( 16 ) of the sterile container is arranged to extend. Sterile container according to claim 21, characterized in that the holding arm ( 58 . 60 ; 96 ) a holding frame section ( 36 . 38 ) of the holding frame ( 30 . 32 ) at least partially covered. Sterile container according to one of claims 19 to 22, characterized in that the at least one retaining element ( 50 . 52 ; 86 ) over an angular range ( 88 . 90 . 92 ) in the circumferential direction of the sterile filter ( 26 ). Sterile container according to claim 23, characterized in that the angular range ( 88 . 90 . 92 ) Has values of 10 ° to 180 °. Sterile container according to claim 23 or 24, characterized in that more than one holding element is provided and in that the angular range ( 88 . 90 ) has a value of about 20 °. Sterile container according to one of claims 19 to 25, characterized in that at least two holding elements ( 50 . 52 ) are provided and that the at least two retaining elements ( 50 . 52 ) symmetrically around the gas exchange opening ( 24 . 70 ) are arranged around. Sterile container according to claim 23 or 24, characterized in that a holding element ( 86 ) is provided and that the angular range ( 92 ) has a value of 180 ° or approximately 180 °. Sterile container according to one of the preceding claims, characterized in that centering stops ( 50 . 52 . 74 . 76 ; 86 ) are provided for centering the sterile filter ( 26 ) above the gas exchange opening ( 24 . 70 ). Sterile container according to one of the preceding claims, characterized in that the gas exchange opening ( 24 . 70 ) on the lid ( 10 . 10a . 10b ) is provided. Sterile container according to one of the preceding claims, characterized in that at least one stop ( 74 . 76 ) is provided, which an opening movement of the valve flap ( 26 ) from the valve opening ( 70 ) Limited. Sterile container according to one of the preceding claims, characterized in that the lid ( 10 . 10a . 10b ) is made of a plastic. A sterile container according to claim 31, characterized in that the plastic polyetheretherketone (PEEK) or polyphenylene sulfone (PPSU).