AU2013100420A4 - Sterilisation Wrap - Google Patents

Abstract

Abstract The present invention relates to a sterilisation wrap (30) formed from a single sheet of sterilisation material folded about a fold line (32) to form two parts. The wrap (30) has a first margin (38) adjacent to the fold line (32), a second margin (42) opposite the fold line (32) and adjacent to the first margin (38), and a third margin (40) adjacent to the second margin (42) and the fold line (32). The two parts of the wrap (30) are bonded at the first margin (38) and at the second margin (42) but not at the third margin (40). The present invention also relates to a method of sterilising an article. The method includes the steps of using a sterilisation wrap (30) to wrap the article, and exposing the wrapped article to sterilisation for a sufficient period to substantially sterilise the article. '.34

Description

1 Sterilisation Wrap Technical Field This invention is concerned with a sterilisation wrap suitable for use in hospitals and similar environments. 5 Background of the Invention Sterilisation wraps are used in hospitals and other environments to wrap instruments which have been sterilised for use and reuse. From the mid-twentieth century the practice arose of setting up central sterilisation 10 units for sterilising reusable surgical instruments, etc., and wrapping them for delivery to a hospital ward or theatre. By the 1960s, disposal packaging for sterilised articles was adapted, mostly in the form of kraft paper, which had a good bacteria barrier, was permeable to steam during sterilisation and which could be disposed of easily. 15 However, studies around the same time showed that although the kraft paper and similar substitutes available at that time were superior in acting as a bacteria barrier, compared to surgical cloth which had been used previously, it was found that the paper could degrade over time and the bacteria barrier quality could decrease. 20 Further developments in the 1960s and 1970s saw the establishment of breathable barrier materials suitable for sterilisation wraps and bags. In relation to wraps, in order to reduce the likelihood of a sterility breach, whether by degradation of the wrap material or because of a tear or similar, it became a recommended practice to double wrap articles. In this practice, sheets of 25 sterilisation wrap were provided. An article to be sterilised would be wrapped first in one sheet and then in a second sheet, or else wrapped in one operation, using two sheets together. Typically, the sheets have consisted of laminates of separate layers. For example, a sheet may be made of a laminate of three separate layers, 2 the two outer layers being known as spun bond, being material made from extruded polyolefin fibres. In this example, the inner layer is known as a melt blown layer, also made from extruded polyolefin fibres. The middle, melt blown layer acts as a bacteria barrier, while the outer spun bond layers provide strength. 5 This type of laminate is known as an SMS material. Other laminates may have a different number of layers, with different combinations of spun bond and melt blown layers. Kimberly-Clark products sold under the trade mark KIMGUARD have provided an alternative to the two-step or single step double wrapping of articles to be 10 sterilised, using separate single sheets, as described above. The KIMGUARD products provide separate laminated sheets bonded together at a limited number of sites, the product being distinguishable as two sheets, despite the bonding. It is an object of the present invention to provide a sterilisation wrap which can have advantages over the prior art, or which at least will provide a useful 15 alternative. Disclosure of the Invention Accordingly, this invention provides a sterilisation wrap formed from a single sheet of sterilisation material folded about a fold line to form two parts, the wrap 20 having a first margin adjacent to the fold line, a second margin opposite the fold line and adjacent to the first margin, and a third margin adjacent to the second margin and to the fold line, wherein the two parts of the wrap are bonded at the first margin and at the second margin but not at the third margin. The invention also provides a method of sterilising an article, the method including 25 the steps of: (a) wrapping the article in the sterilisation wrap; and (b) exposing the wrapped article to sterilisation for a sufficient period to substantially sterilise the article.

3 In certain embodiments, the single sheet is square or rectangular in the unfolded state. The single sheet may be folded in half, or it may be folded in a different manner, so that the part folded is of a smaller dimension than the remaining part of the sheet. 5 The single sheet for the sterilisation wrap of the invention may be cut from a larger sheet. It will be appreciated by one skilled in the art that this can result in minimum wastage of sterilisation material. The folded single sheet includes bonding of the two parts at or around margins of the wrap. This may be for the purpose of forming a pocket. One margin of the 10 wrap may be left open for insertion of an article to be sterilised. Bonding may be effected by any suitable means, such as by ultrasonic bonding, bonding using heat, by stitching or by use of adhesives. The adhesive used in this option may be any suitable adhesive known in the art. Preferably, the bonding is achieved by continuous sealing. Alternately, the 15 bonding is achieved by spot sealing. In the method of the invention, the sterilisation to which the wrapped article is to be exposed may be any suitable sterilisation. One example is the use of steam. Others are ethylene oxide (EtO) and plasma-based sterilisation. In the sterilisation wrap and method of the invention, the single sheet is preferably 20 a laminate of a polyolefin, preferably polypropylene. More preferably, the laminate has five layers, the first two and the fifth layer being spun bond and the third and fourth layers being melt down. The laminate may be referred to as SSMMS. The single sheet is not limited to this example. In choosing the sterilisation material for use in the wrap and method of the 25 invention, attention should be given to the qualities required for a sterilisation wrap, such as the need for the sterilisation procedure to penetrate the sterilisation material so as to sterilise the article, while at the same time providing a bacteria barrier to prevent contamination of the article and to provide strength to the material so that it is not easily compromised by the article or during handling after 4 the sterilisation procedure. As will be appreciated by one skilled in the art, the SSMMS laminate referred to above is regarded as sterilisation material. Brief Description of the Drawin2s 5 The invention may be better understood from the following non-limiting description of a preferred embodiment, in which: Figure 1 shows in plan view a single sheet being an embodiment of the invention; Figure 2 shows a folded version of the embodiment in Figure 1; and 10 Figure 3 shows a second folded version of the embodiment in Figure 1. Detailed Description of the Drawin2s Possible and preferred features of the present invention will now be described with particular reference to the accompanying drawings. However, it is to be 15 understood that the features illustrated in and described with reference to the drawings are not to be construed as limiting on the scope of the invention. The embodiment in Figure 1 shows wrap 30 in a square format sheet 12. It will be appreciated by one skilled in the art that a similar embodiment may be derived from a rectangular sheet. 20 Wrap 30 is shown as having two fold lines 32 and 34. Wrap 30 is made from an SSMMS laminate. When square sheet 12 is folded in half about fold line 32, the sterilisation wrap 30 shown in Figure 2 results. If square sheet 12 is folded about lower fold line 34, the sterilisation wrap illustrated in Figure 3 results, where the flap formed by folded 25 part 36 is a darker colour which contrasts against the exposed part of wrap 30, as indicated by the cross hatching.

5 In Figures 2 and 3, the wrap 30 has a first margin 38 adjacent to the fold line 32 (or 34), a second margin 42 opposite the fold line 32 (or 34) and adjacent to the first margin 38, and a third margin 40 adjacent to the second margin 42 and the fold line 32 (or 34). The two parts of the wrap 30 are bonded at the first margin 38 and 5 at the second margin 42 but not at the third margin 40, so that the wrap forms a pocket open at the third margin 40. The embodiment illustrated may be subject to bonding, using heat, ultrasound, stitching or adhesion. It will be appreciated by one skilled in the art that the embodiments described are 10 not limiting on the scope of the invention and that modifications and variations may be made within the spirit of the invention.

Claims (5)

1. A sterilisation wrap formed from a single sheet of sterilisation material folded about a fold line to form two parts, the wrap having a first margin adjacent to the fold line, a second margin opposite the fold line and adjacent to the first margin, and a third margin adjacent to the second margin and the fold line, wherein the two parts of the wrap are bonded at the first margin and at the second margin but not at the third margin.

2. The sterilisation wrap of claim 1, wherein the single sheet is square or rectangular in shape.

3. The sterilisation wrap of claim 1 or claim 2, wherein the two parts of the wrap are bonded at the first margin and at the second margin by continuous sealing.

4. A method of sterilising an article, the method including the steps of: (a) wrapping the article in a sterilisation wrap as claimed in any one of claims 1 to 3; and (b) exposing the wrapped article to sterilisation for a sufficient period to substantially sterilise the article.

5. A sterilisation wrap substantially as herein described with reference to any one of the accompanying drawings