DE102016101913A1 - Medical sterile container with sandwich structure - Google Patents

Abstract

The present invention relates to a medical sterile container (1) having a trough-like first container part (2) with a container opening (3), a lid-like second container part (4) for closing the container opening (3) of the first container part (2) and one of the first container part (2) and second container part (4) surrounded container interior (10), wherein the first container part (2) and / or the second container part (4) has a laminate structure or sandwich structure with an outer layer (14), a core (16 ) and an inner layer (15), wherein the outer layer (14) and the inner layer (15) made of stainless steel and the core (16) consists of a material having a higher thermal conductivity than stainless steel and / or with a lower specific gravity than stainless steel consists. The invention further relates to a method for producing a medical sterile container (1), in which a laminate composite with a first edge layer (14), a second edge layer (15) and between the first edge layer (14) and the second edge layer (15) arranged core (16) by deep drawing to a trough-like first container part (2) and / or a lid-like second container part (4) is formed, wherein the two edge layers (14, 15) made of stainless steel and the core (16) made of a material with a higher coefficient of thermal conductivity than stainless steel and / or is less specific gravity than stainless steel.

Description

The present invention relates to a sterile medical container having a trough-like first container part with a container opening, a lid-like second container part for closing the container opening of the first container part and a container interior surrounded by the first container part and second container part. It further relates to a method for producing a medical sterile container, in particular a medical sterile container according to the invention.

Sterile containers are well known in the art and are used in medicine, particularly in surgery, to sterilize surgical instruments, implants, and the like, and to temporarily store and transport after sterilization. Items to be sterilized are placed in the container interior. The container is closed by placing the container lid on the container base and, with the items to be sterilized received therein, supplied to a sterilizer by exposing the container interior to a sterilizing gas, e.g. Steam is applied.

The sterile container is heated for this purpose and cooled after passing through the respectively required sterilization cycles. For the purpose of the fastest possible and efficient sterilization, including cooling, the highest possible thermal conductivity and possibly good heat storage properties of the sterile container are advantageous.

Common sterile containers of the prior art are made of either aluminum or stainless steel. Aluminum aluminum containers offer the advantage of good heat distribution, good heat storage and a relatively low weight. However, it is disadvantageous that aluminum is not particularly resistant to chemicals. Aluminum sterile containers can therefore only be cleaned with special cleaning procedures that take place in a pH-neutral or at least mildly alkaline medium. It is known to improve the cleaning ability lid and tray of Sterilcontainers formed from deep-drawn anodized aluminum. While this provides good thermal conductivity and capacity with low weight, it is still associated with cleanability limitations as only neutral or mild alkaline cleaners can be used.

Stainless steel sterile containers offer excellent chemical resistance. They therefore have a high resistance to aggressive environments in chemical cleaning processes and can be subjected to a wide range of cleaning options (even at high pH values). However, this advantage is diminished by the disadvantage of a relatively high weight and a relatively low thermal conductivity and capacity compared to aluminum, especially for the same sheet thicknesses.

Against this background, the present invention has the object to provide a medical sterile container and a method for its production, which can be cleaned with a variety of cleaning methods, in particular with (highly) alkaline cleaning method, and at the same time a good heat capacity and conductivity for efficient sterilization. Furthermore, the container should be easy and inexpensive to produce.

This object is achieved according to the present invention by a sterile container according to the preamble of claim 1, which is characterized in that the first container part and / or the second container part has a laminate structure or sandwich structure with an outer layer, a core and an inner layer wherein the outer layer and the inner layer are made of stainless steel and the core consists of a material with a higher coefficient of thermal conductivity than stainless steel and / or with a lower specific gravity than stainless steel.

The object is achieved with regard to the production by a method for producing a medical sterile container, in particular a medical sterile container according to the present disclosure or according to one of the appended claims, characterized in that a laminate composite with a first edge layer, a second edge layer and a core arranged between the first edge layer and the second edge layer is formed by deep drawing to a trough-like first container part and / or a lid-like second container part, wherein the two edge layers made of stainless steel and the core of a material having a higher thermal conductivity than stainless steel (higher than 15 W / mK, in particular higher than 75 W / mK, preferably in the range of 200 to 250 W / mK) and / or with a lower specific gravity than stainless steel (lower than 7.85 g / cm ³ , especially lower than 5 g / cm ³ , preferably in the range of 2 -3 g / cm ³ ).

By the invention and in particular the sandwich construction of the sterile container, the advantageous properties of the material stainless steel, such as better compared to aluminum cleanability and resistance to aggressive environments, with the advantageous properties of the material aluminum, as compared to stainless steel better thermal conductivity and capacity . be specifically combined and united for the first time in a sterile container. It is crucial that the final surface of the sterile container, ie the outer layer formed from one edge layer of the laminate or laminate material and the inner layer formed from the other edge layer of the laminate, is made of stainless steel, since the container only then the desired high durability and cleaning suitability of stainless steel has. The core provides the desired thermal conductivity and heat storage capacity and desirable low weight. In contrast to the state of the art in sterile containers, the invention achieves easy cleaning (cover sheet stainless steel) of the sterile containers with simultaneously high heat capacity and conductivity (eg aluminum core).

Advantageous embodiments of the invention are claimed in the subclaims and are explained in more detail below.

An embodiment of the invention is characterized in that the core has a layer of aluminum or an aluminum alloy. In this way, a particularly good thermal conductivity (237 W / mK) and heat storage capacity of the sterile container is achieved. The specific gravity is 2.75 g / cm ³ . Alternatively or additionally, the core may have a layer of a metal alloy, in particular of a copper alloy. Thus, thermal conductivity and heat storage capacity can be set up specifically.

A further embodiment of the invention is characterized in that the core has a layer of solid material, in particular consists entirely of it. In this case, the heat storage capacity is particularly high. Alternatively or additionally, the core may comprise a layer of a foam material, nonwoven material or braiding material, in particular completely consist thereof. In this way, a lightweight sterile container can be produced while maintaining good thermal conductivity and / or heat storage capacity. The core of the sterile container can be constructed according to the invention in particular variable multi-layered. That is, it can be constructed not only of a material and / or a single layer, such as a metal or a metal alloy, but also with other metal alloys, for example, based on copper and / or multiple layers. In particular, the core does not have to consist of a solid material, but can, for example, be present completely or at least partially or in sections as foam and wire mesh.

A further embodiment of the invention is characterized in that the core and at least one layer of outer layer and inner layer are joined together. This connection can be done in particular by gluing, welding or cold welding. In this context, preference is given to using a sandwich material or sandwich sheet which does not bond the individual layers by gluing but has been brought together by mechanical / thermal methods in order to achieve high temperature stability. Such sterile containers can be advantageously exposed to sterilization temperatures in ranges of about 134 ° C without being damaged.

A further embodiment of the invention is characterized in that the sandwich structure is sealed at edges of the first container part and the second container part, respectively, such that the core is tightly enclosed by the inner layer and the outer layer. In such a sterile container, the core is advantageously completely surrounded by material of the inner and outer layer and thus shielded from the environment and sealed. With regard to the production of the sterile container, the first boundary layer and the second boundary layer are sealingly connected to one another before or after deep-drawing, so that the core is surrounded tightly by the two boundary layers.

A further embodiment of the invention is characterized in that the inner layer and / or the outer layer has or have peripheral edge tabs projecting beyond the core, which are folded around the core and sealed to the inner layer or the outer layer, in particular glued or welded are. Such a sterile container is particularly easy to produce. With regard to the production of the sterile container, it is of particular advantage if the core is processed by the material removal after the deep drawing, so that over the edge of the core protruding edge tabs of the first edge layer and / or the second edge layer are formed. Alternatively, according to the invention, a sealing flap may be attached to the edge of the first edge layer and / or the second edge layer, in particular welded or glued.

A further embodiment of the invention is characterized in that the inner layer and / or the outer layer has a layer thickness in a range of about 0.3 mm to about 0.9 mm, preferably in a range of about 0.4 mm to about 0, 7mm, more preferably of about 0.5mm or have. The total sheet thickness, ie the sum of the layer thicknesses of all layers of the laminate, is preferably in a range of about 1 mm to about 3 mm. By particularly thin layer thicknesses in the above areas, the weight of the sterile container can be kept low while that of the Inner layer and the outer layer surrounded and shielded core is securely protected.

A further embodiment of the invention is characterized in that the core has a layer thickness in a range of about 0.6 mm to about 1.2 mm, preferably in a range of about 0.8 mm to about 1.0 mm. Such layer thicknesses cause a heat storage capacity particularly suitable for sterile containers and their sterilization.

Particularly advantageous embodiments of the invention are characterized in that the sterile container consists of a sandwich sheet with an aluminum core with a thickness of 1.2 mm and stainless steel cover plates or outer layer and inner layer with a thickness of 0.7 mm and is deep-drawn in the form of a container lid / tray / becomes. In another embodiment, the sterile container may consist of a sandwich sheet with an aluminum core with a thickness of 1.0 mm and stainless steel cover sheets or outer layer and inner layer with a thickness of 0.5 mm and be deep drawn in the form of a container lid / tray. In a further embodiment, the sterile container can consist of a sandwich sheet with a copper core with a thickness of 1.2 mm and stainless steel cover sheets or outer layer and inner layer with a thickness of 0.7 mm and be deep-drawn in the form of a container lid / tray. In another embodiment, the sterile container may consist of a sandwich sheet with a core made of stainless steel wire mesh with a thickness of 0.6 mm and stainless steel cover sheets or outer layer and inner layer with a thickness of 0.3 mm and be deep-drawn in the form of a container lid / tray. In a fifth embodiment, the sterile container may consist of a sandwich sheet with an aluminum foam core with a thickness of 0.8 mm and stainless steel cover sheets and inner layer with a thickness of 0.4 mm and be deep-drawn in the form of a container lid / tray.

• – bessere Wärmekapazität im Vergleich zu reinen Edelstahlsterilcontainern (bei Verwendung eines Aluminiumkerns
• – bessere Wärmeverteilung im Vergleich zu reinen Edelstahlsterilcontainern (bei Verwendung eines Aluminiumkerns)
• – höhere Beständigkeit gegen chemische Reinigungsverfahren im Vergleich zu Sterilcontainern aus Aluminium
• – geringeres Gewicht im Vergleich zu reinem Edelstahl (bei Verwendung eines Aluminiumkerns, aber auch bspw. bei der Verwendung von Edelstahldrahtgeflecht

In particular, the following advantages can be achieved by the invention:

• - Better heat capacity compared to pure stainless steel containers (when using an aluminum core
• - better heat distribution compared to pure stainless steel containers (when using an aluminum core)
• - higher resistance to chemical cleaning processes compared to aluminum sterile containers
• - Lower weight compared to pure stainless steel (when using an aluminum core, but also, for example, when using stainless steel wire mesh

In summary, the invention combines the advantages of stainless steel with those of aluminum in a sterile container, thus enabling a sterile container with high resistance to chemical cleaning processes, good heat distribution and good heat capacity. A particular embodiment of the invention is the use of a stainless steel wire mesh as a core. In this case, the weight saving compared to the exclusive use of stainless steel is the main advantage.

Further features and advantages of the present invention will become apparent from the following exemplary and non-limiting description of the invention with reference to figures. These are merely schematic in nature and are only for understanding the invention. Showing:

1 a sterile container in a perspective view,

2 a sectional view of a part of the container of 1 along the line II-II and

3 a sectional view of a part of the container of 1 along the line III-III.

In 1 is a sterile container 1 shown in perspective according to the invention. This has a trough-like first container part 2 , in the present embodiment, as a container base 2 or container pan 2 can be designated with a container opening 3 and a lid-like second container part 4 , which in the present embodiment also as a container shell 4 or container lid 4 may be designated for closing the container opening 3 of the first container part 2 on. The container base 2 consists essentially of a container bottom 5 , two longitudinal walls 6 . 7 and two end walls 8th . 9 , which work together with the container lid 4 a container interior 10 surround and limit. The container lid 4 is by means of two locking units 11 , which are designed as tamper-evident locks, at the bottom of the container 2 shut off. The container lid 4 is by means of a sealing unit not shown in the figures with respect to the container base 2 sealed. The container interior 10 is by means of a filter unit 12 fluidly with the environment 13 connected. However, this is not necessary for the invention and the sterile container 1 can therefore be formed without such a filter unit.

The first container part 2 and the second container part 4 are each manufactured as a molded part by deep drawing of a sandwich material or laminate. Its structure is in 2 based on a cross section through the container bottom 5 along the line II-II in 1 shown. The floor 5 (as well as the walls 6 . 7 . 8th . 9 ) has an outer layer 14 on the outside of the container pan 2 formed. The inside of the container trough 2 is through an inner layer 15 educated. Between the outer layer 14 and the inner layer 15 is a core 16 arranged or formed.

The outer layer 14 and the inner layer 15 are made entirely of stainless steel. The core 16 whereas it consists of a material with a higher coefficient of thermal conductivity than stainless steel. As a core 16 Also, a material with a lower specific gravity than stainless steel can be used. The core 16 , the outer layer 14 and inner layer 15 are connected. In the present embodiment, this is done via cold welding. Alternative options are gluing or welding.

As 3 shows have the inner layer 15 and the outer layer 14 at the edge over the core 16 protruding edge tabs 17 and 18 on. These embrace the core 16 and are folded around him. The side flap 17 the outer layer 14 is sealing with the edge tab 18 the inner layer 15 connected. The outer layer 14 and the inner layer 15 therefore form a kind of dense recording for the core 16 out.

LIST OF REFERENCE NUMBERS

1

 A sterile container

2

 first container part, container lower part, container pan

3

 container opening

4

 second container part, container top, container lid

5

 container bottom

6

 longitudinal wall

7

 longitudinal wall

8th

 bulkhead

9

 bulkhead

10

 Container interior

11

 locking unit

12

 Atmosphere, environment

13

 Filter unit, filter

14

 Outer layer, surface layer

15

 Inner layer, surface layer

16

 core

17

 Outer flap, sealing flap

18

 Outer flap, sealing flap

Claims (13)

Medical sterile container ( 1 ) with a trough-like first container part ( 2 ) with a container opening ( 3 ), a lid-like second container part ( 4 ) for closing the container opening ( 3 ) of the first container part ( 2 ) and one from the first container part ( 2 ) and second container part ( 4 ) surrounded container interior ( 10 ), characterized in that the first container part ( 2 ) and / or the second container part ( 4 ) a laminate structure or sandwich structure with an outer layer ( 14 ), a core ( 16 ) and an inner layer ( 15 ), wherein the outer layer ( 14 ) and the inner layer ( 15 ) are made of stainless steel and the core ( 16 ) consists of a material with a higher coefficient of thermal conductivity than stainless steel and / or with a lower specific gravity than stainless steel. Medical sterile container ( 1 ) according to claim 1, characterized in that the core ( 16 ) has a layer of aluminum or an aluminum alloy. Medical sterile container ( 1 ) according to claim 1 or 2, characterized in that the core ( 16 ) has a layer of a metal alloy, in particular of a copper alloy. Medical sterile container ( 1 ) according to one of the preceding claims, characterized in that the core ( 16 ) comprises a layer of solid material and / or a layer of a foam material, nonwoven material or braiding material. Medical sterile container ( 1 ) according to one of the preceding claims, characterized in that the core ( 16 ) and at least one layer of outer layer ( 14 ) and inner layer ( 15 ) are glued together, welded or cold-welded. Medical sterile container ( 1 ) according to one of the preceding claims, characterized in that the sandwich structure at edges of the first container part ( 2 ) or of the second container part ( 4 ), such that the core ( 16 ) from the inner layer ( 15 ) and the outer layer ( 14 ) is tightly enclosed. Medical sterile container ( 1 ) according to claim 6, characterized in that the inner layer ( 15 ) and / or the outer layer ( 14 ) at the edge over the core ( 16 ) superior edge tabs ( 17 . 18 ) having the core ( 16 ) are folded around and with the inner layer ( 15 ) or the outer layer ( 14 ) are sealingly connected, in particular glued or welded. Medical sterile container ( 1 ) according to one of the preceding claims, characterized in that the inner layer ( 15 ) and / or the outer layer ( 14 ) has a layer thickness in a range of about 0.3 mm to about 0.9 mm, preferably in a range of about 0.4 mm to about 0.7 mm, particularly preferably of about 0.5 mm or have. Medical sterile container ( 1 ) according to any one of the preceding claims, characterized characterized in that the core ( 16 ) has a layer thickness in a range of about 0.6 mm to about 1.2 mm, preferably in a range of about 0.8 mm to about 1.0 mm. Method for producing a medical sterile container ( 1 ), in particular a medical sterile container ( 1 ) according to one of the preceding claims, characterized in that a laminate composite with a first surface layer ( 14 ), a second boundary layer ( 15 ) and one between the first boundary layer ( 14 ) and the second boundary layer ( 15 ) arranged core ( 16 ) by deep drawing to a trough-like first container part ( 2 ) and / or a lid-like second container part ( 4 ), wherein the two boundary layers ( 14 . 15 ) are made of stainless steel and the core ( 16 ) consists of a material with a higher coefficient of thermal conductivity than stainless steel and / or with a lower specific gravity than stainless steel. Method according to claim 10, characterized in that the first boundary layer ( 14 ) and the second boundary layer ( 15 ) are sealingly joined together before or after deep-drawing, so that the core ( 16 ) close to the two boundary layers ( 14 . 15 ) is surrounded. Method according to claim 10 or 11, characterized in that the core ( 16 ) is processed after deep drawing on the edge material erosion, so that over the core ( 16 ) peripheral edge tabs ( 17 . 18 ) of the first boundary layer ( 14 ) and / or the second boundary layer ( 15 ) be formed. Method according to one of claims 10 to 12, characterized in that the first boundary layer ( 14 ) and / or to the second boundary layer ( 15 ) at the edge a sealing flap ( 17 . 18 ), in particular welded or glued.

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