WO2007045943A1

WO2007045943A1 - Box-like container for surgical sterilized tools and method for packaging thereof

Info

Publication number: WO2007045943A1
Application number: PCT/IB2006/001973
Authority: WO
Inventors: Umbro Staccini; Elizabetta Maria Anzanello
Original assignee: Tecnosanimed S.R.L.
Priority date: 2005-10-21
Filing date: 2006-07-18
Publication date: 2007-04-26
Also published as: ITMI20052009A1; EP1937321A1

Abstract

Closable box-shaped container for sterilised surgical instruments intended for a particular surgical operation on an individual patient, characterised in that it comprises a first covering means provided with passages for the sterilisation steam and a second covering means fixed in a removable manner to said box-shaped container, said second covering means being available at least above part of said first covering means.

Description

"Box-like container for surgical sterilized tools and method for packaging thereof"

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FIELD OF THE INVENTION The present invention concerns a closable box-shaped container for sterilised surgical instruments (or surgical tools) and relative packaging method for use in operating rooms. PRIOR ART It is known that in common use in hospital environments closable box- shaped containers are preferably used for storing and transporting surgical instruments from the central sterilisation unit, where the surgical instruments together with the equipment contained in the closable box-shaped container are sterilised, to the operating room, where said surgical instruments are used on the patient. It is also known, as described in US 4,643,303, that these box-shaped containers contain the surgical instruments necessary for the surgical operation and that the latter are connected in a removable manner to supporting elements fixed on the base of the container and adjustable inside the container according to the type of surgical instrument chosen for the surgical operation and the type of surgical operation. In this way, for each surgical operation, the surgeon arranges the supporting elements so as to facilitate identification of the surgical instrument and its disengagement from the supporting element at the time of use in the operating room. Said container is advantageously provided with a removable cover with passages housing biobarriers, for example textile filters, Pasteur labyrinths or pressure valves for passage of the sterilisation steam. Said barriers, after permitting inlet of the steam at high temperature for sterilisation, prevent the subsequent inlet of contaminants. In this way the surgical instruments can be sterilised directly with the box-shaped container closed, thus facilitating transport of said container from the central sterilisation unit to the operating room. This type of container for sterilised surgical instruments is not without drawbacks. In fact, the effectiveness of said biobarriers is significantly affected by the microclimatic conditions of the premises where the box-shaped containers for surgical instruments are kept while awaiting use and by the length of time they are kept. This makes it impossible to draw up an appropriate stock plan for said containers for scheduled or emergency surgical operations, since the level of efficiency and prompt response required in hospitals cannot be guaranteed. It should be added that the box-shaped container, although sterilised together with the surgical instruments during sterilisation of the same, has the drawback of being exposed to the contamination of contaminating substances in the environment in which it is stored. Therefore, even if the contents can, in theory, remain sterile, the container can have a bacterial load higher than the level permitted in the operating room and therefore introduce a possible risk factor for the patient undergoing the surgical operation. In addition, a further drawback of said container lies in the fact that the hospital personnel assigned to transport of the containers cannot check correspondence of the contents of the container with the needs of the surgical operation and/or the requirement of the surgeon other than by raising the lid provided with biobarriers. It is furthermore known that after each use the surgical instruments need to be removed from the operating room and transported to the decontamination and sterilisation areas; in order to guarantee safety of the personnel assigned to the handling of said instruments, further sealed containers are used inside which the contaminated surgical instruments are collected.

The need is therefore felt, in the hospital environment, to produce a container for surgical instruments that can be stored and kept sterile, even for several days, in the storage premises near to the hospital operating department and which at the same time allows the hospital personnel to easily and quickly identify the container to be used for a particular surgical operation and for a particular surgeon. A further object of the present invention is to permit removal of the surgical instruments used during a surgical operation in the operating room without this constituting a risk for the personnel assigned to said removal.

A further object of the present invention is to reduce the bacterial load of the surgical instruments and of the box-shaped containers for said surgical instruments introduced into the operating room. SUMMARY OF THE INVENTION

These objects are all achieved by the present box-shaped container for surgical instruments according to the attached claims and in particular due to the possibility of inserting on the box-shaped container a first covering means provided with passages for sterilisation of the surgical instruments contained in said container and a second sealing covering means for safe handling of said box- shaped container.

According to a particular embodiment of the box-shaped container, in correspondence to the upper surface of the second covering means graphic means are applied for identification of the contents of the container and/or further means for automatic identification of the contents via recognition elements of the barcode type or similar. Subsequently the container is packaged in a plastic film, preferably heat-shrink, to guarantee conservation of the sterility of the surgical instruments contained in the container and sterility of the container itself before being used.

In accordance with a second embodiment of the box-shaped container according to the invention, the second covering means is a plastic film, preferably heat-shrink, with said graphic means for identification of the contents inside the container and/or further means for automatic identification of the contents of the barcode type or similar, positioned between said first covering means and said second covering means. BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the present invention and relative method will be more evident from the detailed description of a preferred but not exclusive embodiment of a container for sterilised surgical instruments for use in operating rooms, illustrated in the attached figures, in which: figure 1 is a schematic axonometric view of the box- shaped container according to the invention, when open; figure 2 is a section view of the box-shaped container of figure 1 with first covering means, second covering means and means for graphic reproduction and identification of the contents; figure 3 is a view of a graphic reproduction of the set of surgical instruments; figure 4 is a section view of the box-shaped container in accordance with a second embodiment of the invention.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

With particular reference to said figures, 1 indicates the box-shaped container subject of the present invention. The box-shaped container 1, substantially in the form of a parallelepiped, comprises, according to a known technique, a first pair of walls 1 a and 1 c opposite each other and a second pair of walls Ib and Id opposite each other, joined in a continuous manner along the common edges 2a, 2b, 2c and 2d.

Inside the container 1, in correspondence to the lower wall Ie, a supporting grate 3 for surgical instruments 4 is positioned, preferably made of metal, connected to the box by press-fitting or via removable means of the screw type 5, and if necessary comprising means for temporary retaining 6 of said surgical instruments 4 prior to use. Said temporary retainers 6 comprise appropriate clips 14 connected in an integral manner to the supporting grate 3 and made of elastically deformable biocompatible material, for example silicone. Each temporary retainer 6 is produced to house a particular surgical instrument 4 or type of surgical instrument. According to a further embodiment of the container, said temporary retainers 6 are provided preferably by pairs of metal lips (not shown) like a spring on the supporting grate 3 which can deform by pressure when the surgical instrument 4 is inserted. It should be noted that, although in the drawing only one grate 3 has been illustrated, it is possible to provide several grates 3, housed in the container 1 side by side, overlaid or in any other convenient manner. According to a known technique, said box-shaped container 1 is made preferably of metal or biocompatible plastic able to withstand jets of steam at high temperature, of the type generated by autoclaves during the sterilisation of surgical instruments for operating rooms, without losing either their mechanical or chemical properties. On the upper open part 15 of the container 1, opposite the wall Ie, a first covering means 7 is positioned, substantially in the form of a parallelepiped shaped so as to reproduce the design of said upper part 15 of said container 1, but of slightly larger dimensions, so as to lie over and completely cover it, for example resting on the inner ledges 10a, 10b, 10c, and 1Od of the container. Said covering means 7 is provided with suitable passages 11 or slots which, when the box-shaped container 1 is closed, permit passage of the steam for complete sterilisation both of the surgical instruments 4 inside the container 1 and the supporting grates 3 for said surgical instruments 4. Said holes 11 house biobarriers 40, for example fabric filters, Pasteur labyrinths or pressure valves. Said biobarriers 40, after allowing inlet of steam at high temperature for sterilisation, prevent the subsequent inlet of contaminants. In this way the contents inside the container can be sterilised directly in the closed box-shaped container 1, thus facilitating transport of the box-shaped container 1 from the central sterilisation unit to the operating room.

Advantageously, at the end of sterilisation, in a completely sterile environment, a second covering means 12 is positioned above the first covering means 7 for safe handling of said box-shaped container 1, as will become clearer from the following description of the packaging method of said container 1.

Said second covering means 12 engages on the container 1 substantially reproducing the form of the first covering means 7. Stable application of said covering means 12 on said container 1 can be obtained, preferably, by means of grooves 17 arranged in the vicinity of the edges 9a, 9b, 9c and 9d of the covering means 12, which engage by press-fitting in the protruding edges 8a, 8b, 8c and 8d of the relative walls 1 a, 1 b, 1 c and 1 d of the container 1. Advantageously above said second covering means 12 a graphic reproduction 13 of the set of surgical instruments contained in it is provided. Each graphic reproduction 13 is obtained, preferably, by means of photographic device and can present a further identification symbol 16 of the position of each surgical instrument 4 that can be positioned on the relative supporting grate 3. Together with the graphic reproduction 13 a further means for identification of the set of surgical instruments 4 can be provided, for example a barcode 14 or one or more identifiers of the contents and related functions, such as a colour code (not shown here) per type of surgical operation or type of set rather than an alphanumeric name. Said container 1 comprising a first covering means 7, a second sealing covering means 12 and graphic means 13 for identifying the contents, is further packaged in a plastic film 18, preferably heat-shrink, which, once heated, shrinks guaranteeing a further seal inside the closed container 1, protection of the container 1 and a further blocking system for any accidental opening of the container 1.

According to a second embodiment of the invention (figure 4), the closable box-shaped container can comprise a first covering means 7, a second sealing covering means 12 and graphic means 13 for identifying the contents positioned between said first covering means 7 and said second covering means 12. According to said embodiment said second covering means 12 is a plastic film, preferably heat-shrink, so as to guarantee both sterile storage of the surgical instruments contained in said container 1 and safe transport thereof. The operating characteristics of the box-shaped container 1 described above will be evident from the following description of the method of packaging of said box-shaped container 1. According to a preferred form of packaging of said box-shaped container 1, the surgical instruments 4 necessary for a particular surgical operation are correctly positioned inside the box-shaped container 1, resting on grates 3 previously housed in the container 1. Subsequently said box-shaped container 1 is closed by positioning of a first covering means 7 provided with passages 11 for the sterilisation steam. The closed container 1 then undergoes the sterilisation process inside a sterilisation apparatus (not shown here) positioned inside the central sterilisation unit.

As soon as sterilisation of the surgical instruments 4 and of the box- shaped container 1 housing them is complete, a second sealing covering means 12 is applied, in a completely sterile environment, for the safe handling of said surgical instruments.

Subsequently the container is packaged in a film 18 of thermoplastic material to guarantee the sterility of the container 1 and the surgical instruments 4 contained in it. The phase of packaging said box-shaped container in a plastic film 18, preferably heat-shrink, can be preceded by the phase of applying between the upper surface of said second covering means 12 and the packaging film 18 one or more indicators and/or graphic representations 13 of the instruments housed in the container 1. According to an alternative form of the method, said box-shaped container 1, as soon as it has come out of the sterilisation apparatus, can be packaged by means of a second sealing covering means 12, for example a plastic film, preferably heat-shrink, without the need to apply a further plastic film 18. In said case the phase of affixing a second sealing covering means 12 is preceded by the phase of applying between the upper surface of said first covering means 7 and said second covering means 12 one or more indicators and/or graphic representations 13 of the instruments housed in the container 1. From the central sterilisation unit the closed box-shaped container 1 is sent to the operating room or, alternatively, to the room assigned to storage of the box-shaped containers 1. At the end of the surgical operation in which that container is used for that particular surgical operation, the contaminated surgical instruments are re-placed in the box-shaped container 1 and both the first covering means 7 and the second covering means 12 are affixed.

Application of the second sealing covering means prevents the contaminated surgical instruments being a danger to the hospital personnel assigned to removal of the surgical instruments 4.

The container, according to the invention, is simple in terms of structure and construction, adaptable to any construction form; it keeps the surgical instruments contained in it sterile for a long time due to affixing of the first covering means, the second sealing covering means and the heat-shrink film. In addition the insertion of graphic reproductions of the contents inside the box positioned above said second covering means with the box-shaped container closed permits quick easy identification of the set of surgical instruments used for that particular surgical operation by that particular surgeon and more accurate programming of the surgical operation on the basis of a programme of stocks of sterilised isolated containers stored in a room provided for the purpose in the vicinity of the operating room. It should be furthermore noted that the possibility of having graphic reproduction of the contents and identification means if necessary, of the barcode type, permits the production of a system for sanitisation, disinfection and sterilisation of surgical instruments with automatic recognition of the container in each phase of the sanitisation process both before and after the surgical operation, making the work performed in the central sterilisation unit simpler and safer, from the cleaning phase to re-packaging and sterilisation of the used surgical instruments.

Furthermore the packaging method is simple and effective, guaranteeing a high level of sterility even after long-term conservation of the container and, subsequently, safe removal of said contaminated surgical instruments at the end of the surgical operation.

The invention, conceived as above, is subject to numerous modifications and variations all falling within the scope of the inventive concept.

Furthermore all the details can be replaced by other technically equivalent details. In practice any materials, forms and dimensions can be used according to requirements, without departing from the scope of the following claims.

Claims

1 ) Closαble box-shaped container for sterilised surgical instruments intended for a particular surgical operation on an individual patient, characterised in that it comprises a first covering means provided with passages for the sterilisation steam and a second covering means fixed in a removable manner to said box- shaped container, said second covering means being provided at least above part of said first covering means.

2) Container as claimed in claim 1 , characterised in that it is packaged in a plastic film.

3) Container as claimed in claim 2, characterised in that said film is heat-shrink.

4) Container as claimed in claim 1 , characterised in that said second covering means is a plastic film. 5) Container as claimed in claims 2, 3 or 4, characterised in that it presents between the outer surface of said second covering means or said first covering means and said plastic film, one or more indicators of its contents and/or relative functions.

6) Container as claimed in claim 5, characterised in that said indicators comprise a graphic representation of the instruments housed in the container.

7) Container as claimed in claim 5, characterised in that said indicators comprise instructions on the use and function of the instruments housed in the container. 8) Container as claimed in claim 5, characterised in that said indicators comprise labels or symbols for traceability of the container and relative instruments before and after the surgical operation.

9) Container as claimed in one or more of the preceding claims, characterised in that the instruments are housed in the container on supporting grates.

10) Container as claimed in claim 9, characterised in that means are provided for temporarily attaching one or more single instruments to the relative supporting grate. 1 1 ) Packaging method for surgical instruments by means of a box-shaped container as claimed in the claims from 1 to 10, comprising the following phases: a) position the surgical instruments inside said box-shaped container; b) affix on said container a first covering means provided with passages for the sterilisation steam; c) provide for sterilisation of the surgical instruments contained in said container and of the container itself; characterised in that it comprises subsequently to phase c) of the method the following phase: d) affix at least partly above the first covering means a second covering means, said second covering means being connected in a removable manner to said box- shaped container. 12) Packaging method for surgical instruments as claimed in claim 1 1 , characterised in that said phase of affixing a second covering means at least partly above the first covering means comprises the phase of packaging said container in a plastic film, said film constituting said second covering means. 13) Packaging method for surgical instruments as claimed in claim 1 1 , characterised in that said phase of affixing a second covering means at least partly above the first covering means is followed by the phase of packaging said container in a plastic film.

14) Packaging method for surgical instruments as claimed in claim 12 or 13, characterised in that said phase of packaging said box-shaped container in a plastic film is preceded by the phase of applying to the box-shaped container one or more indicators and/or graphic representations of the instruments housed in the container. 15) Packaging method for surgical instruments as claimed in any one of the claims from 1 1 to 14, characterised in that at the end of use of the sterilised surgical instruments intended for a particular surgical operation on an individual patient, the following phases are performed: e) positioning the surgical instruments used inside said box- shaped container; f) affixing said second covering means above the first covering means.