WO2008084047A1

WO2008084047A1 - Thermal closing unit for a sterilization receptacle

Info

Publication number: WO2008084047A1
Application number: PCT/EP2008/050150
Authority: WO
Inventors: Roland Antoni; Lutz-Rüdiger ZEMKE
Original assignee: Roland Antoni; Zemke Lutz-Ruediger
Priority date: 2007-01-09
Filing date: 2008-01-08
Publication date: 2008-07-17
Also published as: DE102007002105A1

Abstract

The invention relates to a thermal closing unit (10) for a sterilization receptacle, which has at least one opening (21). The opening (21) is closed at the usage temperature by at least one closing sealing element (4), which is attached to a deformation element (3) made of a memory metal or a memory plastic. If the sterilization temperature is above the usage temperature, the closing sealing element (4) releases the opening by deforming the deformation element (3).

Description

Thermal lock unit for a sterilization container

The invention relates to a thermal closure unit for a sterilization container, which has at least one opening.

By 1990, 99% of the sterilization containers used in clinical sterilization practice were made of metal. With the advent of a variety of instruments for minimally invasive surgery, more and more plastic containers had come on the market until 1992 due to the better processability, the cheaper manufacturing process and the realization of the most complex design variants. With these new generations of plastic containers the transport and the use phase could be realized at the same time. The disadvantage is the introduced hole grids both in the upper part and in the lower part, which should ensure the inflow of steam for sterilization, as well as the removal of moisture in the drying phase of the sterilization program. To ensure sterile conditions, these containers had either to be placed in steel containers, wrapped in sterile wipes or sealed in sterile bags. This is very understandable, time-consuming and no longer meets the requirements of current national and international clinical sterilization practice.

The object of the invention is to provide a self-closing closure unit, which allows an inflow of steam during sterilization and closes the container automatically after completion of the process.

This is achieved by a thermal closure unit having the features of claim 1.

A container equipped with the closure unit according to the invention is closed in a sterile manner before and after sterilization and is automatically opened by the closure unit during the sterilization process and automatically closed again by the same after the drying process.

The thermal sealing unit for use in sterilization containers makes it possible to carry out a safe, maintenance-free and also, according to the authorities, documentable sterilization procedure for medical products of all kinds, since the container is sealed sterile-tight before and after sterilization. Only during the sterilization process is it automatically opened by the closure unit and closed again automatically by the same after the drying process. This ensures sustainable storage security after the process has ended.

The sterilization container, consisting of a lower part and an upper part, in the closed state, ie at temperatures of less than 50 ° - 80 ⁰ C, a represent sterile-tight locked unit. All openings that connect the interior and the external environment are closed.

If now the locked sterilization container placed in the autoclave and heated, so occurs at a temperature of 80 ° -110 ° C, the one or more existing thermal closure unit in action and releases the openings to the interior. Above this temperature, the sterilization process is now initiated and it is carried out by means of vacuum and Dampfeinströmzyklen and further heating up to the sterilization temperature, the safe sterilization in the interior of the container.

After completion of the sterilization, the interior drying takes place by moisture is removed from the interior with a slow temperature reduction by means of controlled vacuum generation. The thermal shutter unit closes at the temperature of less than 110 ° -80 ⁰ C the interior again sterile-tight manner.

The fact that the pressure in the interior changes due to temperature adaptation or temperature fluctuations, which could lead to a tight suction of the upper part, is avoided by a ministerial filter. About him only the air exchange takes place at over / under pressure.

At the bottom of the container, an injection-molded or deep-drawn part of a resterilisierbarem plastic material such as PP, PMP, PSU, PES, PEI, PPSU, PPO, PPS, PTFE or PEEK, laterally mounted between two and eight thermal lock units, one to four in each case the long sides or one to four at the short Pages. Adapted to the respective thermal closing units is on the short sides of a carrying handle construction or are on the long side, the closures for Oberteilarretierung.

The upper part, likewise an injection-molded or deep-drawn part, preferably of one of the abovementioned resterilisierbarem plastic materials, includes a seal to the lower part, which consists of a thermally resilient elastic plastic material such as SI, TPE, PUR, PTFE to greater tolerances in the distance lower part / Balance upper part and at the same time build a sterile barrier between lower part / upper part.

In the upper part of the sterilization container, a plurality of thermal closure units according to the invention can be installed. It is particularly advantageous to provide two closure units, wherein: at a first, the deformation element is mounted on a covering the opening of the sterilization container covering and is connected via a connecting element with the closure seal member which is disposed below a lid on the sterilization container, and at a second the deformation element on the top of a lid on the sterilization container covering cover is mounted and the closure sealing element between the top of the lid and the deformation element is arranged.

This creates a double security:

In the first closure unit, the sealing element presses from the outside onto the container and thus acts as a pressure relief valve with a high container pressure.

In the case of the first closure unit, the sealing element pushes from the inside onto the container wall and therefore, if necessary, makes it possible to equalize the pressure at a high negative pressure in the container.

By setting the bias of the Verschlussdich- management elements and / or the deformation elements can be preset, which differential pressure in each case should cause the opening. However, this refers to pressures at service temperature. At the sterilization temperature, all seal sealing elements open and allow the influx of steam.

The sterilization container, consisting of the container base and container upper part, in the closed state is a locked unit with a closed interior. All openings which connect the interior and the external environment are closed with the closure seals of the thermal closure units.

Now, if the locked sterilization container placed in the autoclave and heated, so occurs at a predetermined temperature of eg T ~ 80 ... 110 ⁰ C, the one or more existing thermal sealing unit in action and are the openings to the interior by lifting the closure sealing elements by means of the memory metal or memory plastic strip existing deformation elements free.

Above this temperature, the sterilization process is initiated and by means of vacuum / steam cycles and further heating up to the sterilization temperature sterilization carried out in the interior of the container.

After sterilization is complete, interior drying takes place by removing moisture from the interior with a slow temperature reduction and vacuum. The thermal closure unit closes at a pre-set temperature, which is defined by the use of memory materials, in particular 110 ° -80 ° C, by means of the attached to the memory metal or memory plastic strip seals the openings to the interior of the sterilization container again. The sterilization container is further cooled in this closed state and can later be removed sterile from the autoclave.

The use of external sealing sealing elements and sealing sealing elements in the interior of the sterilization container enables a quick reaction to external influences.

The thermal closure unit is constructed in detail as follows:

Provided are memory strips of metal and / or plastic as deformation elements for the closure sealing elements, which directly contact the opening edge region. The number of memory material strips is preferably set to two pieces. This makes it possible to operate two sealing gaskets directly with the memory material strips.

The geometric shape of the individual memory material strips is due to mechanical conditions such as Size of the closure unit, the sealing behavior, etc. different.

The material used is preferably surface sections of a memory material based on multilayer metal layers of up to 30 layers or polymer matrix structures with memory-effect characterization.

The closure sealing element is preferably contoured out as a stiff shape and can have various geometric shapes.

The invention will be explained in more detail using an exemplary embodiment with reference to the drawing. The figures show in detail:

1 shows a sterilization container with two thermal sealing devices in plan view.

Fig. 2 is a section along the line A-A in Fig. 1 and

Fig. 3 is a section along the line B-B in Fig. 1st

In a view of the lid region of the sterilization container 20 shown in FIG. 1, a container wall 25 encloses an interior space 22. Two thermal closure units 10, 10 'are arranged on its lid 23. These are arranged on a common cover plate 8, which maintains a distance to the top of the cover via spacers 9.

Between cover plate 8 and spacers 9 strip-shaped deformation elements 3 are clamped in the their middle are each connected to a closure sealing element 4, 5.

In the case of the upper closure unit 10 ', which is shown in detail in FIG. 2, the deformation element 3' rests on the top side of the cover in the illustrated use state. The associated closure sealing element 4 is located in a recess in the lid 23 of the sterilization container 20 and contacted there the surrounding area of an opening 21. When heated, the deformation element 3 ', buckles or bulges in the arrow direction and lifts the closure seal member 4 from the opening 21 , Upon cooling, due to the memory characteristic, it again assumes the configuration shown in FIG. 2 and returns the closure sealing element 4 to the opening 21.

The reverse arrangement is selected in the closure unit 10 '. Here, a recess for receiving a closure sealing element 5 on the underside of the lid 23 is provided. The closure sealing element 5 is connected to the deformation element 3 via a connecting element 7, which projects through the opening 21.

An inner cover plate 24 protects the opening 21 or the closure sealing element 5 from contact by sterilizing agent 20 present in the sterilization. List of reference numbers:

10.10 'Thermal lock unit

3, 3 'deformation element

4.5 sealing sealing element

6 attachment for deformation element

7 connecting element

8 cover plate

9 spacer element

20 sterilization containers

21 opening

22 Interior of the sterilization container

23 lids

24 inner cover plate

25 container wall

Claims

Claims:

A thermal closure unit (10, 10 ') for a sterilization container (20) having at least one opening (21),

characterized in that the opening (21) at use temperature by at least one closure sealing element (4, 5) is closed, which is fastened to a deformation element (3, 3 '), which formed from a memory metal or a memory plastic and wherein the closure sealing element (4, 5) releases the opening at a sterilization temperature above the temperature of use by deformation of the deformation element (3; 3 ').

2. Thermal closure unit (10 ') according to claim 1, characterized in that the deformation element

(3 ') is mounted on a covering element (8) covering the region of the opening (21) on the sterilization container (20) and via a connecting element (7) with the closure sealing element (5) which is located below a lid (23) on the sterilization container (20 ) is connected.

3. Thermal closure unit (10) according to claim 1 or 2, characterized in that the deformation element

(3) on the top of a lid (23) on which the sterilization container (20) covering cover member (8) is mounted and the closure sealing element

(4) between the top of the lid (23) and the deformation element (3) is arranged.

4. Thermal closure unit (10, 10 ') according to claim 1 or 2, characterized in that the deformation element (3, 3') is strip-shaped.

5. Thermal closure unit (10, 10 ') according to one of claims 1 to 4, characterized in that the deformation element (3, 3') is formed from a memory metal or a memory plastic surface element, the

6. Thermal closure unit (10, 10 ') according to one of claims 1 to 5, characterized in that the deformation element (3, 3') in a thickness of 0.1 to 20 mm in the cover plate (8) is introduced.

7. Thermal closing unit (10, 10 ') according to one of claims 1 to 6, characterized in that the deformation element (3, 3') is fastened to the bearing point under a pretension of 0.1 to 25 mm.

8. Thermal closure unit (10, 10 ') according to one of the preceding claims, characterized in that the closure sealing elements (4, 5) consist of a polymer material of groups SI, TPE, PUR, PTFE.

9. Thermal closure unit (10, 10 ') according to any one of the preceding claims, characterized in that the attachment (6) of the deformation elements (3, 3') to the closure sealing elements (4) and (5) in ge glued, welded, clamped or riveted form.

12

10. Thermal closure unit (10, 10 ') according to one of the preceding claims, characterized in that the cover element (8) consists of a polymer material of the groups PP, PMP, PSU, PES, PEI, PPSU, PPO, PPS, PTFE, PEK, PEEK is formed.

11. Thermal closure unit (10, 10 ') according to one of the preceding claims, characterized in that the cover element (8) is provided with spacer elements (10, 10').

12. Thermal closure unit (10, 10 ') according to claim 11, characterized in that the spacer elements (10, 10') are made of a polymer material of the groups PP, PMP, PSU, PES, PEI, PPSU, PPO, PPS, PTFE, PEK , PEEK are formed.

13. Sterilization container with at least one thermal closure unit according to at least one of the preceding claims.

14. Sterilization container according to claim 13, characterized by a first closure unit according to claim 2 and a second closure unit according to claim 3.

15. Sterilization container according to claim 13 or 14, characterized in that the housing walls (20) made of a polymer material of the groups PP, PMP, PSU, PES, PEI, PPSU, PPO, PPS, PTFE, PEK, PEEK, or a Me- tallmaterial the groups aluminum, titanium, stainless steel V2A / V4A are formed.

16. Sterilization container according to one of claims 13 to 14, characterized in that below the opening (21) and spaced from an underside of the lid (23) an inner cover plate (24) is arranged.

17. Sterilization container according to claim 16, characterized in that the inner cover plate (12) made of a polymer material of the groups PP, PMP, PSU, PES, PEI, PPSU, PPO, PPS, PTFE, PEK, PEEK, or of a metal of the groups aluminum , Titanium, stainless steel V2A / V4A is formed.